WO2019140027A1

WO2019140027A1 - Method and system for managing clinical trial participation

Info

Publication number: WO2019140027A1
Application number: PCT/US2019/012959
Authority: WO
Inventors: Eric Walter Theodore Chojnicki; Eric Robert FEDYK; Magdalena SCHOENEICH; Riley T. SMITH; Carol Susan Meyer SOKOLOWSKI; Stephan Weber
Original assignee: Takeda Pharmaceutical Company Limited
Priority date: 2018-01-10
Filing date: 2019-01-10
Publication date: 2019-07-18

Abstract

A method includes receiving clinical trial document language associated with a clinical trial and interpreting the clinical trial document language. The method further includes executing trial management program configured to display a graphical user interface on a screen of a participant device. The trial management program is configured to display, in the graphical user interface, a first information window including the clinical trial document language. The trial management program is further configured to receive an input from a user for a second information window including the interpreted clinical trial document language, and to display the second information window including the interpreted clinical trial document language. The trial management program may be further configured to provide responses and prompts to a participant based on verbal inputs received from the participant device, and to coordinate with third party services based on clinical trial requirements.

Description

Method and System for Managing Clinical Trial Participation

TECHNICAL FIELD

[0001] This disclosure relates to managing participation in clinical trials. BACKGROUND

[0002] Clinical trials are utilized by healthcare organizations to evaluate the effects of various treatments on human health. A staggering number of clinical trials fail to meet participant recruitment requirements resulting in delay of the anticipated time to completion of the trial, leading to increased costs of the development of the drug, device, or vaccine for which the trial was undertaken. In addition to delayed recruitment, early trial termination by trial participants - absent medical reason and/or voluntary discontinuation - may result in an inability to draw conclusions at trial completion due to loss of statistical power. For example, one analysis found that 19% of registered trials that closed or terminated in 2011 either failed to meet accrual goals (85% of expected enrollment) or were terminated early due to insufficient accrual.

[0003] As a result of low participation, many viable treatments either remain unavailable or are delayed in the time at which they become available to the general public. Furthermore, challenges in recruiting trial participants indirectly lead to increased costs, as healthcare organizations must expend additional resources to satisfy recruitment requirements. One group estimates that the U.S. pharmaceutical industry allocates up to 40% of clinical trial budgets towards participant recruitment. Insufficient recruitment also results in missed opportunities for participants who can benefit from clinical trials, and wastes time, funds, and other resources of participant and healthcare organizations. Several factors are commonly associated with poor participant recruitment. For example, difficulties in understanding the medical language and complexities of the clinical trial process prevent many candidates from participating in clinical trials. Additionally, the lack of accessible, participant-friendly assistance and resources also contributes to participants quitting trials before they have completed the treatment. DESCRIPTION OF DRAWINGS

[0004] FIG. 1A and 1B are schematic views of an example system for managing a clinical trial participant.

[0005] FIGS. 2A and 2B are schematic views showing operations of the components of the system of FIGS. 1A and 1B.

[0006] FIGS. 3A-3D are schematic views of example graphical user interfaces displaying clinical trial document language for a participant.

[0007] FIG. 4A-4D are schematic views of example graphical user interfaces displaying a conversational interface for a participant.

[0008] FIGS. 5A-5C are schematic views of example graphical user interfaces displaying a third-party application interface for a participant.

[0009] FIGS. 6A and 6B are schematic views of example graphical user interfaces displaying an event calendar for a participant.

[0010] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION

[0011] Despite significant advances in modern medicine, there remains an ongoing need for improved treatments of many medical conditions. In order for new treatment methods, devices, and medications (collectively“interventions”) to be approved prior to commercialization or medical use, the approval process requires that the intervention must be demonstrated to be safe and efficacious through a clinical trial process. The National Institute of Health defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the those interventions on health-related biomedical or behavioral outcomes. However, recruitment of trial participants is an ongoing obstacle to conducting successful clinical trials. Reasons for poor recruitment include inability to identify participants who may be eligible for a specific clinical trial, availability of time and resources for the participant (i.e. transportation, child care, paid time off from work), and the length and complexity of application and consent forms. Therefore, it is desirable to have a clinical support system 100 (FIGS. 1A and 1B) that advises participants 10 and manages participation in clinical trials. Additionally, the clinical support system 100 may be configured to satisfy applicable regulatory requirements for maintenance of confidentiality of client related data and information exchanged between components of the system 100.

[0012] Referring to FIG. 1A and 1B, in some implementations, the clinical support system 100 analyzes clinical trial parameters for a participant 10 and coordinates resources to assist the participant 10 in participating in the clinical trial. As used herein, the participant 10 refers to a trial participant that may be located at some remote location, such as the participant’s 10 residence or place of employment. As used herein, the term“clinic” or“clinical” may refer to a medical facility, such as a hospital, treatment clinic, doctor’s office, or hospital call center. In some examples the clinical support system 100 includes a network 20, an application service provider (ASP) server 110, a participant device 120, a trial administrator system 130, and one or more third-party applications 140.

[0013] The ASP server 110 may include a data processing hardware 112 in communication with non-transitory memory 114. In some examples, the ASP server 110 may be a distributed system, including a plurality of data processors. The ASP server 110 provides the participant 10 and/or the trial administrator 30 with the trial manager 160 executable on the data processing hardware 112 of the ASP server 110. The trial manager 160 is accessible by the participant device 120 and/or the trial administrator system 130 through the network 20 via one or more of a downloadable mobile application, a web-site application, or a downloadable program executable on the data processing hardware 122, 132 of the participant device 120. The ASP server 120, or potentially a unique stand-alone server, may host a program enabling a process that allows a data exchange that is either fully anonymous between server and server clients when desired, or that is fully auditable between server and server clients, as required by the intended use of the data being exchanged.

[0014] The participant device 120 may include, but is not limited to, desktop computers l20a, smart phones l20b, tablets l20c, wearable or implantable sensors, or any other electronic device capable of sending and receiving information via the network 20. The participant device l20a, l20b, includes data processing hardware l22a, l22b, l22c (e.g., a computing device that executes instructions), non-transitory memory l24a, l24b, l24c, and a display l26a, l26b, l26c (e.g., touch display or non-touch display) in communication with the data processing hardware 122. The data processing hardware 122 may execute the trial manager 160, which allows the participant 10 to interact over the network 20 with at least one of the ASP server 110 and the trial administrator system 130. In some examples, the participant device 120 includes a keyboard, speakers, microphones, mouse, and a camera.

[0015] In some implementations, the trial administrator system 130 is located at a doctor’s office, clinic 32, or a facility administered by a hospital (such as a hospital call center) and includes data processing hardware 132, a non-transitory memory 134, and a display 136 (e.g., touch display or non-touch display). The non-transitory memory 134 and the display 136 are in communication with the data processing hardware 132. The data processing hardware 132 may access the trial manager 160 via the network for allowing the trial administrator 30 to graphically view the participant’s interactions with the trial manager 160 on the display 136 and to provide feedback to the participant 10. In some examples, the trial administrator includes a keyboard 138 in communication with the data processor 132 to allow a user (e.g., the administrator 30) to input data, such as participant information. The non-transitory memory 134 maintains participant records capable of being retrieved, viewed, and, in some examples, modified and updated by authorized trial personnel using the trial manager 160.

[0016] The system 100 may further include one or more third-party applications 140, corresponding to respective third-party service providers. As discussed in greater detail below, the trial manager 160 may be in communication with the third-party applications 140, such as transportation services l40a, healthcare services l40b, and caretakers l40c (e.g. childcare) via application programming interfaces (APIs).

[0017] As used herein, the trial manager 160 may refer to computer software that causes data processing hardware 112, 122, 132 to perform a task. In some examples, the trial manager 160 may be referred to as an“application,” an“app,” or a“program.” In the illustrated example, the trial manager 160 is centrally executed on the ASP server 110, and communicates with the participant device 120 and the administrator system 130 via the network 20. In alternative implementations, the trial manager 160 can be executed locally on a variety of computing devices, including mobile computing devices such as smart phones, tablets, and wearable computing devices (e.g., headsets and/or watches). Programs can also be locally executed on other types of computing devices having other form factors, such as laptop computers, desktop computers, or other consumer electronic devices. In some examples, programs may be installed on a computing device prior to a participant 10 purchasing the device. In other examples, the participant 10 may download and install applications on the computing device after purchasing the device.

[0018] The network 20 may include any type of network that allows sending and receiving communication signals, such as a wireless telecommunication network, a cellular telephone network, a time division multiple access (TDMA) network, a code division multiple access (CDMA) network, global system for mobile communications (GSM), a third generation (3G) network, fourth generation (4G) network, a satellite communications network, and other communication networks. The network 20 may include one or more of a Wide Area Network (WAN), a Local Area Network (LAN), and a Personal Area Network (PAN). In some examples, the network 20 includes a combination of data networks, telecommunication networks, and a combination of data and telecommunication networks. The ASP server 110, the participant device 120, and the trial administrator system 130 communicate with each other by sending and receiving signals (wired or wireless) via the network 20. In some examples, the network 20 provides access to cloud computing resources provided by the ASP server 110, which may be elastic/on-demand computing and/or storage resources 24 available over the network 20. The term‘cloud’ services generally refers to a service performed not locally on a user’s device, but rather delivered from one or more remote devices accessible via one or more networks 20.

[0019] FIG. 1B is a schematic of exemplary components of the system 100 of FIG. 1 A. Referring to FIG. 1B, in some implementations, the data processing hardware 112 of the ASP server 110 executes the trial manager 160 for communicating with the participant device 120 and the trial administrator system 130 such that information can be communicated over the network 20 between the ASP server 110, the participant device 120, and the trial administrator system 130.

[0020] The trial manager 160 may include a plurality of subprograms 200, 300, 400 each including a set of instructions for carrying out a unique task. For example, the trial manager 160 includes an interpreter 200, chatbot 300, and a virtual assistant 400. The interpreter 200 is configured to receive a clinical trial document language, to interpret the clinical trial document language, and to output simplified and/or translated clinical trial document language, as described in greater detail below. The chatbot 300 is configured to interact with the trial participant 10 via the participant device 120. For example, the chatbot 300 may receive verbal inputs from the participant device 120, and provide an appropriate response to be communicated to the participant 10 via the participant device 120. The virtual assistant 400 is configured to interface with the participant device 120 and third- party applications 140 to facilitate scheduling and logistics for the participant 10 with the third-party application 140.

[0021] Referring still to FIG. 1B, the trial manager 160 communicates with the participant device, whereby the trial manager 160 cause the screen 126 of the participant device 120 to display a graphical user interface for providing inputs to the trial manager 160, and likewise, for receiving outputs from the trial manager 160. FIGS. 3 A-6B illustrate examples of graphical user interfaces that may be displayed on the participant device 120 by the trial manager 160.

[0022] FIGS. 2A and 2B provide schematic representations of the components and functions of the trial manager 160 and the participant device 120. Referring to FIGS. 2A and 2B, the interpreter 200 is configured to receive clinical trial document language 50, which may be considered complicated and overwhelming to the participant, and generate interpreted clinical trial language 202a, 202b to be transmitted to the participant device 120. The interpreter 200 may include a simplifier 200a and/or a translator 200b, which each receive the tagged clinical trial document language 50 and generate simplified clinical trial language 202a and/or translated clinical trial language 202b, respectively. As used herein, simplified clinical trial language 202b refers to substituting at least a portion of the clinical trial document language 50 to present an alternative version of the clinical trial documents in terms more easily understood by participants 10. For example, words and phrases that are identified by the interpreter 200 as being unnecessary or confusing may be removed or replaced with more general terms, as described with respect to FIG. 3C, below. Alternatively, translated clinical trial language 202b refers to supplementing language of the clinical trial document language 50 or the simplified clinical trial language 202a to present an explanation as to the meaning of the language, and why the language is pertinent to the trial participant 10. Additionally or alternatively, the translated clinical trial language 202b may be used to supplement terms of the simplified clinical trial language 202a that cannot be substituted. The clinical trial document language 50, the simplified clinical trial language 202a, and the translated clinical trial language 202b may be displayed within respective sub-windows 212, 214, 216 of a documents window 210 on the display 126 of the participant device, as shown in FIG. 2A and 3B-3D.

[0023] Referring to FIG. 2B, in some examples the interpreter 200 includes a tagger 204 and at least one of the simplifier 200a and the translator 200b. The tagger 204 receives the clinical trial document language 50 associated with clinical trial documents or forms. Examples of clinical trial documents may include trial protocol documents, informed consent forms, clinical trial journals, and clinical trial diaries. The tagger 204 may receive the clinical trial document language 50 from the trial administrator system 130 or from a different source. The tagger 204 is configured to segregate the clinical trial document language 50 by tagging the document based on an institutional review board (IRB) region 204a and therapeutic area 204b. Accordingly, the interpreter 200 may generate different simplified clinical trial language 202a or translated clinical trial language 202b depending on the IRB region 204a and/or the therapeutic area 204b tagged in the clinical trial document language 50.

[0024] Each of the simplifier 200a and the translator 200b may generate the interpreted clinical trial language 202a, 202b using machine learning. Accordingly, the simplifier 200a may receive a simplified language training data set 52a and the translator 200b may receive a translated language training data set 52b. Each of the data sets 52a, 52b are based on historical documentation from previous clinical trials, including clinical trial document language and corresponding feedback from participants, trial administrators, clinical operation experts, and medical and non-medical writers, for example. Using machine learning, each the trial manager 160 iteratively improves the quality of the interpreted clinical trial language 202a, 202b based on subsequent feedback received for each iteration. For example, the trial manager 160 may evaluate feedback for a first generated interpreted clinical trial language 202a, 202b and make changes to the simplifier 200a and/or the translator 200b to be incorporated in generating a second interpreted clinical trial language 202a, 202b. [0025] Referring still to FIG. 2 A, a schematic view of the chatbot 300 of the trial manager 160 is provided. As shown, the chatbot 300 may reside in the ASP server 110 and interacts with a conversational interface window 310 displayed on the participant device 120 to provide real-time feedback and assistance to the participant 10. The conversational interface window 310 may include inputs 312, such a text input 3 l2a and an audio input 3 l2b, for receiving language from the participant 10. The text input 3 l2a may be provided by a keyboard of the participant device 120, and the audio input 3 l2b may be provided via a microphone of the participant device 120, as described in FIGS. 4B- 4D, below.

[0026] The conversational interface window 310 further includes a dialogue window

314 displaying a textual representation of the interaction between the participant 10 and the chatbot 300. Additionally or alternatively, the participant 10 may interact with the chatbot 300 vocally, whereby responses from the chatbot 300 are provided as audio output via a speaker 128 of the participant device 120. The conversational interface window 310 may interface with the chatbot 300 via middleware 320. In some examples, the middleware 320 is hosted on HIPAA/GDPR compliant cloud computing platform, which is configured to maintain anonymity between participants 10 and third-party applications. One example of a suitable cloud computing platform is the Healthcare Blocks™ platform.

[0027] When a participant 10 provides an input 312 to the conversational interface window 310, the input 312 is transmitted to the chatbot 300 via an API request. The input 312 may be received by the middleware 320, which is configured to remove personal identification information from the input 312 to comply with HIPAA requirements, thereby generating an anonymous input 322. The middleware 320 then forwards the anonymous input 322 to the chatbot 300.

[0028] The chatbot 300 analyzes the anonymous input 322 and determines an appropriate response 302. In some examples, the chatbot 300 may determine a response 302 that is specific to a particular clinical trial associated with the input 322. Here, the chatbot 300 may interface with the interpreter 200 to determine responses 302 based on the clinical trial document language 50. In other examples, the chatbot 300 may determine a generic response 302 that is suitable across a plurality of trials. [0029] In some example, the trial manager 160 may conduct patient analytics as part of determining an appropriate response 302. For example, the chatbot 300 and/or the middleware 170 may query the data storage 170 for participant-specific data, including demographics, previous inputs and responses associated with the participant, trials in which the participant is enrolled. This data can then be analyzed in formulating a response 302 specifically for the participant 310.

[0030] The response 302 from the chatbot 300 may be coded by the chatbot 300, and transmitted to the middleware 320, which then sends a request 324 for the appropriate verbal response 326 to the data storage 170. The verbal response 326 received from the data storage 170 is forwarded from the middleware 320 to the conversational interface window 310, where it is output as text within the display 126 or audio from the speaker 128 of the participant device 120.

[0031] Figures 3 A-3D show schematic views of a graphical user interface (GUI) of the trial manager 160 displayed on the display 126 of the participant device 120 for interacting with the trial manager 160. Referring to FIG. 3 A, the graphical user interface includes a navigation window 500, which functions as a parent window for the trial manager 160. The navigation window 500 includes hamburger button 502 for accessing a dropdown menu or trial manager options, and a search button 504. The navigation window 500 further includes a plurality of navigation buttons 306, which each corresponds to an associated one of the subprograms 200, 300, 400. Accordingly, the selection of one of the navigation buttons 506 by the trial participant 10 causes the trial manager 160 to execute the associated subprogram 200, 300, 400, or alternatively, to transmit an output of the subprogram 200, 300, 400 for display on the participant device 120. In the illustrated example, the navigation window 500 includes a documents button 506a, a chat button 506b, a calendar button 506c, and a logistics button 506d. In other examples, more or less navigation buttons 506 may be included in the navigation window 500.

[0032] As shown in FIGS. 3B and 3C, selection (indicated by pointer hand) of the documents button 506a causes the trial manager 160 to display the documents window 210 on the display 126 of the participant device 120. The documents window 210 includes an original text button 508 and a simplified text button 510 for selectively displaying either one of the clinical trial document language 50 or the simplified clinical trial language 202a based on a selection of the participant 10. As shown in FIG. 3B, the original text button 508 has been selected and the clinical trial document language 50 is displayed in a raw, uninterpreted form in the original text window 212. Alternatively, selection of the simplified text button 510 causes the simplified text window 214 including the simplified clinical trial language 202a to be displayed in the documents window 210, as shown in FIG. 3C

[0033] As shown in FIGS. 3B and 3C, the documents window 210 may include interactive points 512 associated with the clinical trial document language 50 and the simplified clinical trial language 202a. The interactive points 512 correspond to the translated clinical trial language 202b, whereby selection of one of the interactive points within either of the original text window 212 or the simplified text window 214 causes the translated text window 216 to display on the display 126 of the participant device 120, as shown in FIG. 5D, for example. As discussed with respect to FIG. 2A, above, the translated text window 216 supplements the original text window 212 and the simplified text window 214 by displaying the translated clinical trial language 202b associated with portions of the clinical trial document language 50 and the simplified clinical trial language 202a. For example, in some cases certain terms of the clinical trial document language 50 may be identified by the interpreter 200 is lacking clarity. However, it may be necessary that the term remains in the simplified clinical trial language 202a. In this case, both the clinical trial document language 50 and the simplified clinical trial language 202a may include interactive points 512 for displaying the translated text window 216.

[0034] In the illustrated example, the interactive points 512 are displayed as highlighted text (illustrated by bold, underlined text) of the clinical trial documents language 50 or the simplified clinical trial language 202a. Alternatively or additionally, the interactive points 512 may include buttons or prompts for opening the translated text window 216. With reference to FIG. 3D, the translated text window 216 is superimposed over the original text window 212. Alternatively, selecting one of the interactive points 512 may cause the translated text window 216 to open as a new, dedicated window.

[0035] FIGS. 4A-4E provide schematic views of example GUIs rendering the conversational interface window 310 of the trial manager 160, which are displayed on the display 126 of the participant device 120 for allowing the participant 10 to interact with the chatbot 300. With reference to FIG. 3A, the navigation window 500 is initially presented on the display 126. Selection of the chat button 506b by the participant 10, as indicated by the pointer, causes the trial manager 160 to display a conversational interface window 310, as shown in FIG. 4B. The conversational interface window 310 includes a text input window 3 l6a for receiving the text input 3 l2a and a voice input button 3 l6b, which causes the trial manager 160 to record the audio input 312b received via a microphone of the participant device 120. The conversational interface window 310 further includes the dialogue window 314 for displaying a history of verbal inputs 312 and verbal responses 326.

[0036] In the illustrated example, the participant provided an input 312 including a question asking“How often do I need to go to the clinic?” As discussed with respect to FIG. 2A, the trial manager 160 receives the input 312 and provides a verbal response 326. The trial manager 160 may recognize that the input 312 is related to a particular action associated with the trial. For example, the input 312 requests information with respect to periods for clinic visits. Accordingly, the trial manager 160 may provide a response 426 including both an answer 326a and a prompt 326b. The prompt 326b may solicit an additional input 312 from the participant 10, which causes the trial manager 160 to record or schedule a corresponding event 332.

[0037] In one example, shown in FIG. 4B, the prompt 326b from the trial manager 160 asks the participant 10 if an event 332 should be recorded on a calendar. Upon receiving an affirmative input 312 from the participant 10, the trial manager 160 records the event 332 to the calendar. In the illustrated example, a calendar window 600 is provided by the trial manager 160 within the display 126 of the participant device 10. Additionally or alternatively, the trial manager 160 may interface with third-party calendar applications, such as Microsoft Outlook or Google calendars.

[0038] With reference to FIG. 4C, the trial manager 160 may also recognize situations where the participant 10 needs assistance with logistics related to participating in the trial. For example, the trial manager 160 may provide a prompt 326b to the participant 10 when the trial manager 160 records the event 332, as discussed above. Alternatively, the participant 10 may provide an input 312 with a direct request for assistance. In response, the trial manager 160 may display a logistics window 410 for scheduling third-party services. In the illustrated example, the logistics window 410 displays an interface for a transportation service, such a ride-sharing service. The logistics window 410 may include data entry fields 412 for scheduling the service. As shown in FIG. 4C, the data entry fields 412 may be automatically populated by the trial manager 160 based on known dates and locations for the event 432. Additionally or alternatively, the data entry fields 412 may be edited by the participant 10.

[0039] Referring to FIG. 4D, the chatbot 300 may be configured to provide direct responses to inquiries related to the clinical trial document language 50. For example, the participant 10 may provide an input 312 requesting clarification or explanation of one of the terms included in the clinical trial document language 50. In response, the chatbot 300 may provide a verbal response 326 based on the simplified clinical trial language 202a or the translated clinical trial language 202b.

[0040] Referring to FIGS. 5A-6B, the trial manager 160 is configured to allow direct interaction between the trial participant 10 and the virtual assistant 400 via the logistics window 410. In one example, shown in FIG. 5A and 5B, the logistics window 410 is accessible by selecting the logistics button 506d on the navigation window 500. The logistics window 410 may initially present a logistics navigation window 4l0a including buttons 416 for navigating to desired logistics sub-windows 4l0b. Referring to FIGS. 6A and 6B, the participant 10 may directly access a calendar window 600 to view events 332 by selecting the calendar button 506c on the navigation window 500.

[0041] Various implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations can include implementation in one or more computer programs and subprograms that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0042] These computer programs and subprograms (also known as programs, software, software applications or code) include machine instructions for a programmable processor and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms“machine- readable medium” and“computer-readable medium” refer to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term“machine-readable signal” refers to any signal used to provide machine instructions and/or data to a programmable processor.

[0043] Implementations of the subject matter and the functional operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Moreover, subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer readable medium for execution by, or to control the operation of, data processing apparatus. The computer readable medium can be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter affecting a machine-readable propagated signal, or a combination of one or more of them. The terms“data processing apparatus”,“computing device” and“computing processor” encompass all apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers. The apparatus can include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them. A propagated signal is an artificially generated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus.

[0044] A computer program (also known as an application, program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.

[0045] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).

[0046] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read only memory or a random access memory or both. The essential elements of a computer are a processor for performing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio player, a Global Positioning System (GPS) receiver, to name just a few. Computer readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. [0047] To provide for interaction with a user, one or more aspects of the disclosure can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube), LCD (liquid crystal display) monitor, or touch screen for displaying information to the user and optionally a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user's client device in response to requests received from the web browser.

[0048] One or more aspects of the disclosure can be implemented in a computing system that includes a backend component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a frontend component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such backend, middleware, or frontend components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).

[0049] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server. [0050] While this specification contains many specifics, these should not be construed as limitations on the scope of the disclosure or of what may be claimed, but rather as descriptions of features specific to particular implementations of the disclosure. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

[0051] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multi-tasking and parallel processing may be advantageous. Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0052] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results.

Claims

WHAT IS CLAIMED IS:

1. A method comprising:

receiving, at data processing hardware, clinical trial document language associated with a clinical trial;

interpreting, by the data processing hardware, the clinical trial document language; and

executing, at the data processing hardware, a trial management program configured to display a graphical user interface on a screen of a participant device in communication with the data processing hardware, wherein the trial management program is configured to:

display, in the graphical user interface, a first information window including the clinical trial document language;

receive, in the graphical user interface, an input from a user for a second information window including the interpreted clinical trial document language; and

display, in the graphical user interface, the second information window including the interpreted clinical trial document language.

2. The method of Claim 1, wherein the step of interpreting the clinical trial document language includes tagging the clinical trial document language based on at least one of an institutional review board region and a therapeutic area.

3. The method of Claim 1, wherein the step of interpreting the clinical trial document language includes substituting the clinical trial document language with simplified clinical trial document language.

4. The method of Claim 1, wherein the step of interpreting the clinical trial document language includes supplementing the clinical trial document language with translated clinical trial document language.

5. The method of Claim 1 , wherein the first information window includes one or more interactive points corresponding to the interpreted clinical trial language.

6. The method of claim 5, wherein the trial management program is configured to, in response to the user selecting one of the interactive points on the information window: query memory hardware in communication with the data processing hardware to obtain the translated clinical trial language corresponding to the selected interactive point; and

display a translation window including the translated clinical trial language.

7. The method of Claim 5, wherein the interactive points corresponding to the translated clinical trial language are displayed as highlighted clinical trial document language.

8. A system comprising:

data processing hardware; and

memory hardware in communication with the data processing hardware, the memory hardware storing instructions that when executed on the data processing hardware cause the data processing hardware to perform operations comprising:

receiving clinical trial document language associated with a clinical trial; interpreting the clinical trial document language; and

executing a trial management program configured to display on a screen in communication with the data processing hardware a graphical user interface, wherein the trial program is configured to:

9. The system of Claim 8, wherein the operation of interpreting the clinical trial document language includes tagging the clinical trial document language based on at least one of an institutional review board region and a therapeutic area.

10. The system of Claim 8, wherein the operation of interpreting the clinical trial document language includes substituting the clinical trial document language with simplified clinical trial document language.

11. The system of Claim 8, wherein the operation of interpreting the clinical trial document language includes supplementing the clinical trial document language with translated clinical trial document language.

12. The system of Claim 8, wherein the first information window includes one or more interactive points corresponding to the interpreted clinical trial language.

13. The system of claim 12, wherein the trial management program is configured to, in response to the user selecting one of the interactive points on the information window: query memory hardware in communication with the data processing hardware to obtain the translated clinical trial language corresponding to the selected interactive point; and

display a translation window including the translated clinical trial language.

14. The system of Claim 12, wherein the interactive points corresponding to the translated clinical trial language display as highlighted clinical trial document language.

15. A method compri sing :

interpreting, by the data processing hardware, the clinical trial document language; and executing, at the data processing hardware, a trial management program configured to display a graphical user interface on a screen of a participant device in communication with the data processing hardware, wherein the trial management program is configured to:

receive, from the graphical user interface, a first verbal input corresponding to a clinical trial participant;

determine, at the data processing hardware, a response to the verbal input, the response including at least one of a verbal answer to the verbal input and a verbal prompt based on the clinical trial document language; and

transmit, by the data processing hardware, the response for display in the graphical user interface.

16. The method of Claim 15, wherein the operation of interpreting the clinical trial document language includes tagging the clinical trial document language based on at least one of an institutional review board region and a therapeutic area.

17. The method of Claim 15, wherein the determining the response includes identifying at least one clinical trial associated with the verbal input.

18. The method of Claim 15, wherein determining the response includes evaluating at least one of a participant demographic, a previous input associated with the participant, and clinical trials associated with the participant.

19. The method of Claim 15, wherein the trial management program is further configured to:

receive, from the graphical user interface, a second verbal input, the second verbal input being an affirmative input corresponding to the verbal prompt; and

schedule, by the data processing hardware, an event based on the verbal prompt and the affirmative input.

20. The system of Claim 19, wherein the trial management program is configured to communicate, by the data processing hardware, the event to a third-party service provider.