Patient-centered research in the Internet age
Sponsors of clinical research must increasingly focus on improving patient engagement in order to meet many of today’s research challenges, discusses Cal Collins in this article. Promising disruptions are already under way that could define new models for patient recruitment and retention.
In a time when drug development success is becoming scarcer and more expensive, the industry is looking everywhere it can for new, innovative approaches to improving health. Increasingly we hear of the need for patient-centered research. In a highly regulated, process-oriented field such as clinical research, such changes, while essential, are highly disruptive and the outcomes are uncertain. What does patient-centered research mean? For an industry already beset with challenges, is it yet another complex burden, or can it provide a pathway to make the research process more targeted, smarter, and efficient?
“One cross-cutting area where thinking in a more patient-centric manner can help is in recruiting patients.”
Patient-centered research is generally defined as research leading to evidence-based, patient-centered health interventions. It helps people to 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. These principles can apply across all forms of clinical research, from observational outcomes studies to randomized clinical trials. While, due to their focus on ‘real world’ factors, they tend to be prominent in certain research designs – observational research, registries, and pragmatic trials – they have applications to the design and methods of explanatory randomized clinical trials as well.
One cross-cutting area where thinking in a more patient-centric manner can help is in recruiting patients. Meeting recruitment goals is one of the biggest challenges for traditional clinical research. 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.
An often overlooked factor for study participation and retention is convenience. Raising the level of convenience for both the investigator and participant can eliminate one of the biggest obstacles to non-participation or non-completion. A fundamental idea behind patient-centered research is to “amplify the patient’s role in the research process.”2 There are many ways to incorporate increased levels of patient and physician convenience into trial design and execution, particularly using Internet-based technologies.
“Participant retention post-recruitment can be improved by strengthening the connections between participants and researchers…”
For instance, social media can be an effective recruiting tool and an important way to build trust with targeted populations. Disease-specific online communities are becoming more and more prominent for chronic diseases. Matchmaking tools act as intermediators that draw together researchers and participants. “Traditional” social media offers a less targeted, but no less effective, way to engage patients and investigators.
In general, the four key determinants of a person’s likelihood to participate in a trial are prior participation in research, existing relationships with researchers, involvement of trusted leaders, and trust in the organization. Keys to recruiting success in social media should keep these determinants in mind, and engage communities in a thoughtful, ethical way while respecting the norms of the community you are targeting.
Participant retention post-recruitment can be improved by strengthening the connections between participants and researchers, and enhancing communication structures to support these relationships.3 Capturing Patient Reported Outcomes electronically (ePRO), through the web or mobile devices, offers a way to interact with the participant in a meaningful way while also capturing critical data. For instance, offering the ePRO user risk scores and health recommendations based on their data, or using gamification techniques to increase protocol adherence, can enhance the traditional ePRO experience by offering direct, immediate value to the user. Enabling a “Bring Your Own Device” (BYOD) strategy can increase convenience for populations who already own their own smartphones or tablets. Of course, the study design and applicable regulatory considerations should drive when and how these techniques are used.
“There is enormous potential to capture far more robust data and have better follow up than ever before…”
Increased focus on the patient experience is not a phenomenon unique to research, but something that is rapidly permeating healthcare systems. These rapid changes can enhance research engagement. There is enormous potential to capture far more robust data and have better follow up than ever before as widespread infrastructure is put in place for coordinated team-based care, home-based continuous monitoring, and wireless data reporting from medical devices. The (still elusive) promise of using the Electronic Health Record system in research to identify participants and capture clean, accurate trial data is more critical than ever before. As medical practices become more electronic and less paper-driven, investigators and staff should be engaged by providing them trial-specific information at the points in their workflow when they can best make use of it. Conversely, requiring them to go outside the workflows and systems they use in routine practice creates complexity and hassle that can deter research participation. A new level of integration between research and health data systems, based on standards (which exist) and open interfaces (which are coming, as part of Meaningful Use), will be necessary to make good on this potential.
As difficult research questions drive increased complexity in trial designs, many feel that the answer is to use technology in simple, scalable ways to engage more participants in research and capture more data. Dr. Russ Altman, a physician and Stanford professor recently told the New York Times, “There’s a growing sense in the field of informatics that we’ll take lots of data in exchange for perfectly controlled data. You can deal with the noise if the signal is strong enough.”4
1. Getz, Ken, The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, 2007, p40.
2. Pignone, Michael, MD, MPH, Challenges to Implementing Patient-Centered Research, Ann Intern Med. 18 September 2012,157(6):450-451
3. Nicholas Anderson, Caleb Bragg, Andrea Hartzler, Kelly Edwards, Participant-centric initiatives: Tools to facilitate engagement in research, Applied &, Translational Genomics, Volume 1, 1 December 2012, Pages 25-29, ISSN 2212-0661, 10.1016/j.atg.2012.07.001.
About the author:
Cal Collins is the Chief Executive Officer of OpenClinica, LLC the world’s leading open source clinical trial software company. He has also led clinical research informatics collaborations with the National Cancer Institute, the National Center for Research Resources, and the NIH’s Center for Information Technology. Prior to OpenClinica, Mr. Collins served as the Chief Technology Officer of a software consulting company where he oversaw engagements across the spectrum of clinical research. Mr. Collins is a graduate of Harvard College. You may reach Cal at firstname.lastname@example.org.
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