the changing face of clinical trials - patient-centered research in the internet age cal collins...
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The Changing Face of Clinical Trials - Patient-Centered
Research in the Internet Age
Cal CollinsCo-founder & CEOOpenClinica, LLC
June 21, 2013
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What is “Patient-Centered Research”?
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Part of a “learning healthcare system”?
A trendy buzzword?
Where the money is?
Cheaper and less rigorous than RCTs?
A major cultural shift in approaches to research?
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What is “Patient-Centered Research”?
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It is generally defined as research leading to evidence-based, patient-centered health interventions.
Umm, ok.
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Why is Patient-Centered Research Important?
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It helps people make more informed healthcare decisions by directing research toward questions that are important to patients, measuring outcomes that are noticeable and meaningful to them, and producing results that help them weigh the value of healthcare.
Due to a focus on 'real world' factors, it tends to be prominent in certain research designs:
Observational research
Registries
Pragmatic trials
But it has applications to the design and methods of explanatory randomized clinical trials as well.
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Why is Patient-Centered Research Important?
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Less than one-third of people who come in for a screening end up completing a clinical trial.[1]
Employing new ways to engage patients and physicians while increasing their level of knowledge and trust can improve the sponsor’s ability to meet recruitment goals.
[1] Getz, Ken, The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, 2007, p40.
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Why do people participate in trials?
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“Big picture” factors:
Access to needed treatment
Altruism (advancing science, helping those with similar conditions)
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Why do people participate in trials?
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“On the ground” factors that influence decisions:
Prior participation
Relationships with researchers
Trusted leaders
Trust in organization
Incentives
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Why DON’T people participate in trials?
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Recruitment/Matchmaking insufficient
Not convenient
Privacy concerns
Cultural norms
Confusing consent forms
Lack of knowledge about potential to participate
Control over data sharing/secondary use
Source: http://dx.doi.org/10.1016/j.atg.2012.07.001
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What roles can technology play?
Increase convenience (ePRO, web-based access to trial materials, email reminders).
Strengthen connections between participants and researchers. Create infrastructure for coordinated team-based care, home-based continuous monitoring, including wireless data reporting from medical devices.
Enhance communication structures - provide trial-specific information at the points in clinician and participant workflow when they can best make use of it.
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What roles can technology play?
Improve recruitment – social networks, cohort identification through patient record mining
Provide rewards/incentives to participation – gamification, access to health information, risk factors, etc on mobile devices
Better secondary data use/feedback loops
The (still elusive) promise of using the Electronic Health Record system in research to identify participants and capture clean, accurate trial data with less duplication
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What is Open Source? Why does it matter?
Open Source Software is software that allows programmers to freely run, read, redistribute, and modify the software’s source code.
We need new, innovative approaches to improving health outcomes. We need to be integrated and patient-centric, in care and research.
Open Source Software (OSS) can deliver improved integration, quality, and efficiency in patient-centered care and research environments.
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Why Open Source? When people can rapidly download and try things for
free, share ideas with a community, and see each others’ source code, a few surprising things happen:
It’s easier to evaluate… all the way down to the code Technologies get ‘mashed up’ in highly innovative ways Best practices emerge and are shared quickly Interoperability is easier Business can focus on where they contribute the most
value, rather than on the ‘plumbing’
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Prominent Patient Centered OSS Technologies
OpenDataKit (ODK) and OpenXData Mobile data capture by field workers and patients. http://opendatakit.org/ http://www.openxdata.org/
SMART The “App Store” for health care http://smartplatforms.org/
tranSMART Translational research platform (based on i2b2 http://www.transmartproject.org/
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Key Goals for Patient Centered Capabilities in OpenClinica
Patients require a simple interface that can be used without any training. As such, Participant Portal and mobile device solutions must meet several goals:
1. Make it easy for participants to securely access assessment forms and enter data in a timely fashion.
2. Send the participant a reminder when his assessment is due or overdue
3. Make sure the participant completes the correct assessment (assuming there are different questions at different time points).
4. Submit data back to the clinical trials database in real time
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Approach Develop stand alone modules that leverage core
OpenClinica
Study design is done in one place (OpenClinica) and deployed to all modules, including event/CRF design, skip logic, and study calendar => no separate study build process
Provide a simple, intuitive data entry interface and submit data back to the OpenClinica instance.
Provide participants the ability to complete the right forms at the right time plus provide the management tools needed to manage the patient responses.
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Participant Portal Overview Web-based survey and outcomes reporting by clinical
study participants.
A standalone application that interfaces with existing OpenClinica capabilities.
Leverages the existing investment in OpenClinica’s study design, data management, and extract capabilities.
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Participant Portal Overview
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Participant Portal OverviewPortal forms support:
Skip patterns
Real-time data checks
Multiple input types
Repeating Groups*
Simple UI with customizable layout
Design in OpenClinica
* - not implemented for proof of concept
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Tablet-based Data CaptureNeeds:
Tablet-based surveys/instruments for completion by patient
Provide immediate feedback on health risks and conditions for clinicians to use in the patient visit
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Uses existing open source components (OpenClinica, ODK), same technology foundation as Participant Portal
Uses OpenClinica CRF definitions and rules, no additional programming/design necessary.
Touch screen tablet, with support for other modes (SMS, IVR) in the future.
Standards-based form definition (CDISC ODM) provided by EDC System, automatically converted to XForm for mobile client device.
Open source technologies ‘mashed up’ in 9 month development period ODK Dimagi TouchForms OpenClinica EDC
Tablet-based Data Capture
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Vision
True transformation of healthcare must deliver on potential of research via integration into practice (translational research and precision medicine)
PCAST report on Health IT, Dec. 2010:
Nations are creating a “health data infrastructure in which patient data… can be accessed in de-identified form by researchers and public health agencies, and in which a market for applications that enhance EHR usability and patient involvement can flourish”
Nations are creating a “health data infrastructure in which patient data… can be accessed in de-identified form by researchers and public health agencies, and in which a market for applications that enhance EHR usability and patient involvement can flourish”
“Sound medicine needs to be based on empirical evidence… Aggregated de identified information could enable a wide range of studies on such topics as prevention strategies, frequency complications in particular settings, and the individuals response to specific drugs based on genotype”
“Sound medicine needs to be based on empirical evidence… Aggregated de identified information could enable a wide range of studies on such topics as prevention strategies, frequency complications in particular settings, and the individuals response to specific drugs based on genotype”
