Cross-posted from Pfizer's Think Science Now
The rise of the e-patient brings great opportunities — and some unique challenges — to clinical research and the conduct of clinical trials.
Rise of the e-Patient
Much has been written elsewhere about the rise of the e-patient. The white paper “e-Patients: How They Can Help Us Heal Healthcare” defines the e-patient as “a new breed of informed health consumer, using the Internet to gather information about a medical condition of particular interest to them.” Tom Ferguson MD, lead author of the e-patient white paper, described the e-patient as “empowered, engaged, equipped and enabled.”
Some key points about the e-patient:
e-Patients Are Everywhere
According to Pew Research Center’s Internet & American Life Project:
- 61% of American adults look online for health information (the “e-patient”)
- 60% of e-patients say they or someone they know has been helped by following medical advice or health information found on the internet (just 3% say they or someone they know was harmed)
e-Patients Are Organized
Last year The Society for Participatory Medicine was formed to organize a field defined as “a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners.”
e-Patients Are Not a Fad
Earlier this year, the National Library of Medicine hosted their 2010 conference “The ePatient: Digital and Genomic Technologies for Personalized Health Care”. Leaders from academia and government agencies gathered at the National Institutes of Health (NIH) to discuss the implications of genomic, digital and wireless technologies – increasingly patient-facing tools – in the context of comparative effectiveness, innovation and personalized medicine.
In many ways, the e-patient is the future. Their rise brings disruptive change in the delivery of healthcare, and brings similar implications for clinical trials.
e-Patients Are Organizing Around Clinical Research
Today, many patients participate in a variety of online communities. As the New York Times noted earlier this year (“When Patients Meet Online, Are There Side Effects?”), in some of these communities patients have moved beyond chatting or posting free text. Patients are increasingly sharing structured, longitudinal health information with one another. This structured information is databased and used for searching, but is also aggregated and available for research.
In these communities patients are essentially initiating their own research (prompting buzzwords such as Research 2.0 and Crowdsourced Research). They are filling out forms that look very much like the case report forms (CRFs) used in academic clinical research studies. But the patients are not waiting for academics or industry to take interest in their disease – they are self-organizing, collecting data, and analyzing the resulting database. In some cases, these communities have even published results in peer-reviewed journals.
We may be seeing the tip of the iceberg in patient communities publishing scientific findings. Earlier this month, one organization published a paper entitled “Web-Based, Participant-Driven Studies Yield Novel Genetic Associations for Common Traits” in PLoS Genetics. The study was described as a novel participant-driven research program, building a community of patients sharing both self-reported clinical data and genetic information.
Patients sharing data in a community are conducting a form of clinical research, but this should not be confused with a clinical trial. Clinical trials involve prospectively defined protocols (including eligibility criteria and other rules) and participants are often randomly assigned to one of several treatment options. Data generated by patient communities are an important step in the continuum of evidence and knowledge, but may be difficult to compare to a randomized clinical trial.
e-Patients: Opportunities (and Challenges) for Clinical Trials
While e-patients themselves are gathering in communities and may be generating their own research findings, they also bring potential opportunities and challenges for traditional clinical trials.
Patient community initiated research is different from a clinical trial (as noted above), but the roles and tools may be very similar:
- Both rely on an engaged patient as a participant
- Both rely on the participant being interested in self-tracking and reporting
- Both rely on the participant being willing to share data
#1. The engaged e-patient as a clinical trial participant
The most often-cited opportunity with e-patients in clinical trials is around engagement – reaching these patients, informing them about clinical trials, recruiting them to participate. There are many companies offering services in this space, and a seemingly endless number of conferences on the topic. As an example, Pfizer has a website to help patients match for trials, is using YouTube to share information with potential participants, and is building an online community to increase awareness and connect patients to investigators while ensuring privacy. Certainly online patient engagement is one tool to reach patients in support of trial recruitment. But this will not be a silver bullet, and should be considered one of many tools used to execute a recruitment strategy.
#2. The participant self-tracking (quantified-self)
There is an exciting trend in healthcare described as ‘quantified self’ – well described in Wired magazine and online at QuantifiedSelf.com characterized by individuals who self-track a range of information about themselves (often in the context of measuring their health and wellness). Many of the tools these self-trackers are using begin to resemble the electronic patient reported outcomes (ePRO) or electronic diaries we look to use in clinical trials, just requiring validation.
#3. Participants sharing their health data
Similar to patients sharing data in online communities, clinical trials have always been dependent upon the participant being willing to share data to improve scientific knowledge and public health, often without any direct benefit conferred back to the participant. Today’s e-patient, however, is highly engaged and informed in their health, appreciating their role as owner of their own health data.
Understand the Risks
The e-patient who advocates being an informed participant in their healthcare, may not be comfortable with many traits of a randomized and blinded clinical trial. This raises unique challenges:
- How can we keep the e-patient engaged in a clinical trial if we are unable to share traditional “participatory” information (or even their treatment assignment)?
- What happens when the e-patient is engaged with communities of patients online? Are they sharing information that may provide clues to treatment assignment? Are they sharing suspected adverse events (that may create a cascade of other participants reporting symptoms)? How does the pharmaceutical sponsor educate the study participants, or monitor or engage in this conversation?
- Is the e-patient more likely to show a response to placebo (because they are more highly engaged in their health)?
I have seen online patient communities with threads dedicated to discussing participating in specific studies. Some of these discussions have included:
- Coaching on how to adjust certain subjective tests to meet eligibility criteria
- Sharing potential symptoms that may indicate who is on active drug (vs. placebo)
The e-patients in these instances are doing what they do best – sharing information with one another. But the scientific implications for the study can include enrolling ineligible patients, unblinding, and influencing adverse event reporting rates. Disrupting the ability to answer important questions is not in the interests of the study sponsor, investigator or the participant.
New Opportunities, New Horizons
Moving forward we cannot ignore the role of the e-patient in a clinical trial.
Some questions to consider:
- How can we participate in the online discussions and communities to answer questions about studies? Can we educate participants about online conversations that may impact the scientific integrity of the study?
- Are there new opportunities for engagement with the e-patient that can help to mitigate some of the sacrifice they are making serving as a blinded participant? Specifically:
- Can we bridge the gap between the tools a self-tracking e-patient (“quantified self”) is using and the validated tools we are using in clinical trials?
- How can we best share the learnings from a clinical trial back with the participant?
There are clearly more questions than answers. But there are incremental solutions underway. One example is Pfizer’s work with the Center for Information & Study on Clinical Research Participation (CISCRP). Working together, Pfizer and CISCRP recently demonstrated a new way to share clinical research learnings and results with participants. This should be just the beginning of a new relationship between participants and clinical trials.
Excellent blog Craig.
I think the degree of visibility of information that is shared between ePatients in the future will be adjustable based on the demands of the study. If you take the PatientsLikeMe approach - no blinding exists, all information is shared openly. One step from that would be patient details blinded - you can see they exist, but you don't know who or where.
Next, you could control visibility across patient groups on outcomes. You might have information that subjects were being dosed, but the outcome, etc might be restricted. Finally, you, as per typical EDC systems, you would have complete blindness to other subjects. All of these can relatively easily be segmented based on the demands of the study, and could be applied based on metadata on the same ePatient Clinical trials platform.
With regards bridging the gap between patient information portals, and Clinical information systems such as EDC - I think this is already in the works. Many systems are moving towards 'the cloud' with open interfaces and methods to share data & metadata. CDISC standards are allowing a degree of simplication in dialogues between systems. By controlling the access to the scope of information that reaches the EDC system to the sponsor, you have also potentially answered some of the data privacy issues that persist in European countries specifically.
Thx again for posting.
I have 2 comments:
In multiple patient attitudinal research surveys I have conducted (20+ countries) for clients, I am stunned to see that most patients, under 40 years of age, indicate they receive most of the information about their disease from Facebook Forums. This is the patient support group of the future and it will be very difficult for our industry to keep content positive and balanced.
I want to address one of the last points Craig makes about follow-on patient contact. I worked on a 5 year analysis of why patients did not return to NIH for a subsequent study; one of the major patient dis-satisfactions was that they never received "the rest of the story" from the researchers. In other words, patients wanted to know what became of the drug so they could feel esteem around their contribution to mankind. We need to do the same with all trial participants.
Data collection in clinical trials is mainly a manual process; Investigators at the investigational sites manually transcribe/record data from the hospital files (source) on case report forms (CRFs).
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