In January, the Food and Drug Administration published its final guidance on the use of patient-reported outcomes (PRO) instruments to support claims in approved medical product labeling. Although the guidance does not address the use of PRO instruments beyond this scope, it does lend itself to some interesting connections and observations about using PRO tools for other purposes. For instance, Ntrypoint Media has been talking to life sciences firms over the past year about capturing patient-reported outcomes before, during, and after clinical trials to accelerate recruitment and maximize retention at a lower cost.

The FDA defines a PRO as:

Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.

The FDA says sponsors should begin PRO instrument development and evaluation early in their medical product development life cycle, prior to clinical trial enrollment, and involve patients in the process who represent members of the intend population for the trial. If an online research community is used to capture patient-reported outcomes and general feedback on an ongoing basis, this requirement would be inherently satisfied. Also, actual recruitment can occur faster if the very target population for the trial is a captive audience who helped developed the PRO instrument from the start.

There are special considerations for electronic PRO tools. We are all seeing more and more of our information transfer to digital media and repositories. This can make recording PROs easier. Nevertheless, offline protocols still must be adhered to even if an ePRO instrument is incorporated. For example, direct control over source data should be exercised by the clinical investigator, not the sponsor or the contract research organization. An ePRO tool in the form of an online research community can simplify the process of screening patients for recruitment and give the clinical investigator the appropriate level of control.

The FDA’s published guidance demonstrates that the government is taking electronic health records (EHR) and personal health records (PHR) seriously. We can likely expect the FDA to issue similar guidance on how to use PRO for other purposes. Using PRO to identify and screen clinical trial participants is an obvious place to focus. This approach can support claims of the presence of hard-to-diagnose conditions, the environmental causal relationship on health conditions, and the likelihood of patient compliance throughout the trial.

Today, we learned that health reform took one step closer to its goal of expanding health insurance coverage to perhaps 30 million more Americans. Likely the politicians will agree to disagree. There is one thing we need more agreement on: personal responsibility. Whose responsibility is it to eat well, exercise, and get regular health check-ups? What about limiting children’s exposure to health risk factors like smoking, lead, and allergens?

While health reform is important, it is also essential to consider the major role individuals have to play in monitoring and managing their own health. If a person’s level of health insurance goes from none to some, or good to great, it wouldn’t change that person’s habits or alert them to lifestyle changes to improve their health. It also wouldn’t necessarily foster a closer, information-sharing relationship with their personal physician. And finally, it’s hard to see the positive correlation between greater health insurance and greater clinical research to fuel medical breakthroughs.

I guess I agree with the need for health reform, but fear the perception shared by many that this is all we need to improve public health. A segment of the public sector and private industry recognizes it will also take better drug surveillance methods and more effective health education. Unfortunately, those aren’t the focus of today’s health reform.

While Washington politicians duke it out over healthcare reform and what President Barack Obama called “health insurance” reform in his press conference on Wednesday night, ordinary consumers are cooking up a reform of their own. Young people who graduated this year without job prospects or health insurance and those workers who have lost their jobs and their health insurance, have found a way to change the game.  It’s called feelWellOnline.com. It’s a new site developed and operated by Frisco, Texas-based Ntrypoint Media now in its seventh month in beta that lets consumers, particularly those who are uninsured, earn “credits” to reduce or eliminate what they pay for healthcare by proactively getting involved in clinical research sponsored by academic institutions and big pharma.

Ntrypoint Media hopes legislators will pay more attention to this form of healthcare or health insurance reform that helps the uninsured by asking them to take personal responsibility for managing their health, rather than taxpayers. Hundreds of consumers have already signed up and earned over a million social credits to cover the cost of over-the-counter medications and preventive services from participating merchants. feelWellOnline.com, similar to sites like Inspire and PatientsLikeMe, is also one of the game-changing ways pharmaceutical, biotechnology, and medical device companies are engaging directly with consumers to inform them about clinical trials, track adverse events and improve screening and retention of clinical trial patients. According to Newsweek, 80 percent are delayed at least a month because of low enrollment. feelWellOnline.com does not sign up consumers for clinical trials, but facilitates the pre-participation education process, post-trial nurturing phase and referrals from patients to people they know who would benefit from participating in a clinical trial.

What makes feelWellOnline.com so different from typical online research communities or other social media such as Facebook and Twitter is how the site addresses information security, regulatory compliance such as the Health Insurance Portability and Accountability Act (HIPAA), and Good Clinical Practice (GCP), including informed consent. For example, HIPAA compliance requires adherence to specific data protection, intended use, auditing and disaster recovery policies. A basic review of most, if not all, social media would show they have a lot of work to do in these areas. Also, GCP requires that no clinical trial investigator involve a person who has not granted the legally effective informed consent or the person’s legally authorized representative.

Ntrypoint Media works with clinical sites, clinical research organizations and life sciences firms running trials in North America, and soon internationally.

There is no shortage of articles written about how pharmaceutical, biotechnology and medical device makers supposedly fear the Internet and social media. That’s why I am glad to see social media playing an increasing role in patient outreach as evidenced by sites like UC and Crohn’s, Novel Patient and PatientsLikeMe. Recent research published on the Pew Internet & American Life Project website found that 64% of Americans search the Internet for health information and defined these internet users as “e-patients.” It goes on to say that this group is more likely than other internet users to engage in social media.

So why is the life sciences industry still treading slowly if the Internet is more or less ripe for engaging e-patients with social media? Likely, it has little to do with fear in the sense that one is afraid of the dark, and more to do with strict regulations that govern their clinical research activities. In general, social media doesn’t fit the clinical research mold because of information security, regulatory compliance and no consideration for Good Clinical Practice (GCP).

• Encryption at all levels of communication, from login to logout, should be applied to protect information shared through social media and using online communities
• Specific data protection, role-based access, intended use, auditing and disaster recovery principles must be followed for HIPAA compliance
• A key component of GCP is protection for patients through Informed Consent

A basic review of most, if not all, social media would show they have a lot of work to do in these areas and the life sciences industry has good cause to be guarded in using tools like Twitter, Facebook and YouTube. However, I came across an article published in May of this year offering 10 suggestions for using Twitter for clinical trial patient recruitment. It offers good suggestions to get the word out about clinical trials, but I would say not as good as an online  research community. The community has to be designed with the considerations described above first and foremost, but also allow clinical investigators to stay engaged with patients before, during and after specific studies are done. The feelWell Online Online Research Community is an example of this approach that bridges the gap between social media and clinical research. Researchers can learn more here. It helps speed up patient recruitment, increase pre-screening intelligence and retain patients throughout the clinical trial and for future studies.

It is time life sciences firms take a more serious look at social media in the form of an Online Research Community like feelWell Online.