If they can pull it off, this could totally change not only the way cancer is treated, but the way cancer drugs are developed and approved.

Foundation Medicine’s goal is to create a way for a cancer patient to compare their normal genome to their cancer genome, then see all the mutations. Ultimately, this comparative information could provide a personalized guideline for treating the cancer - essentially personalized medicine based on a person’s DNA.

It is easy to see how this will require a more personalized approach to clinical trials. If such an inventory of medicine is to be created to target each type of tumor a person has based on that individual’s own DNA, how will such medicines get tested? The traditional clinical trial format relies on the participation of hundreds or thousands of patients who respond to treatment in similar enough ways to prove a treatment can do what it’s promoted to do. That likely will not be the case with this new way of treating cancer.

The future clinical trial format will need to be more “personalized.” Rather than relying on treatment data for a large pool of patients, patient-reported outcomes will play a more central role. Patients will need to carefully keep track of their symptoms and their treatment in order to produce a sufficient amount of information about the efficacy of medicines on a person by person basis. Investigators and clinical research coordinators will even find that it could be easier to recruit participants for clinical trials if they can screen patients using eDiaries or journals.

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.

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.

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.

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.

One path we talked about was uninsured people, but we we assumed a lot of things about this group that discouraged us from reaching out to them. One assumption was that they were more likely to be unemployed and therefore hard to reach without a way to identify them through an employer or other trusted source. Instead, with further research on the matter, we found out that uninsured people are more likely to be employed than not, with over 80% of heads of households in this group holding a job according to the Robert Wood Johnson Foundation project, covertheuninsured.org. Another assumption was that uninsured people were more likely to work for very small companies in fragmented markets, and again, difficult to identify or reach out to. In reality, 1 in 5 uninsured workers are employed by firms with 500 or more employees.

So back to our online poll. We figured if most uninsured people are employed, polling LinkedIn users could be interesting. The results were interesting, if not saddening. More and more people are unemployed and uninsured, or employed and yet uninsured. Some of this has to be accounted for by people simply opting out because they do not think they need it. But that cannot be all there is to blame. Here is what we think: most of these people cannot afford it, or their employer doesn’t offer a suitable option for them.

Here are some comments from the respondents of our poll:

I am employed and insured, but after having my baby my insurance per month went from around 60.00 for just me, to 360.00 for both of us. Ridiculous!

Although [I am] un-employed, but insured, my COBRA will run out in two months… 

I am self-employed and insured paying over $15,000 annually for “normal” health insurance to include my immediate family and step-children. This is not including office visits. I see the doctor about 2 or three times annually max, there has got to be a better solution!

Insured but not with a good policy, which is very much the story of most peoples lives. With the amount of money that I spend annually on insurance you might as well lump me in with the percentage of those who don’t have any at all.

Agreed! There has to be a better way. Ntrypoint Media is cooking up a different kind of solution by forging unique partnerships with businesses and the healthcare industry to share information in powerful ways that results in lower costs for everyone involved, and better quality care. Our first project is feelWell Online. Learn more here.

As Alex points out, this is clearly part of a broader trend called consumer-directed healthcare and not necessarily the part that the healthcare industry wants to talk about. Sure there are cons to not going to a professional and receiving accurate diagnoses with a few prescriptions to go along with them. The problem is everywhere we consumers look, it just looks like doctors, pharmaceutical companies and insurance firms are benefiting  even while insurance premiums, drug costs and co-pays are on the rise. How can consumers be expected to trust a system, especially during hard economic times, that is attempting to bankrupt them?

Surely, some key industry players are staying awake at night. Insurers thought consumer-directed healthcare would become what they want it to…high deductible insurance plans, health savings accounts and the like…

What’s surprising, but not really that surprising, is consumers haven’t exactly leaped onto the bandwagon. Maybe they’re out buying vitamins…

Many challenges abound in the current healthcare system. Since 1994, the cost per person of American health care has more than doubled, with an annual growth rate regularly more than twice that of inflation. Fueled by rising costs of prescription drugs, inefficient outpatient care, expensive and unnecessary medical procedures, and ballooning insurance premiums, these costs are a burden on state and federal governments, businesses, and families. It is clear that reform is needed. 

Post marketing surveillance plays a critical role. Adverse events caused by medicines add significant costs to the healthcare system. The U.S. Food and Drug Administration (FDA) has come under increased scrutiny for safety issues associated with approved drugs. The FDA requires drug manufacturers to do extensive safety and efficacy testing of proposed new medications during the approval process. However, after FDA approval, there are concerns that the current post marketing reporting systems fail to:

• Detect drug safety risks and adverse events (AEs) in a timely fashion
• Monitor drug safety in populations that were not included in the drug approval process (e.g., children, pregnant women, and the elderly)
• Identify and contain AEs resulting from off-label medication use 

In response to criticisms that the FDA has not been able to ensure post marketing drug safety at acceptable levels, the FDA has responded with increased drug therapy rejection rates. The investments made in these therapies are placed at risk and may never be recouped, driving up the cost of drugs that do make it through the FDA approval process. 

To address this vicious cycle, the Veterans Health Administration (VHA) Patient Safety Center of Inquiry (PSCI) in Tampa, Florida has determined, by undertaking a series of proactive medication safety surveillance studies, that the use of large-scale national datasets allows researchers to conduct more sophisticated epidemiologic studies to better inform clinical decision-making. Also, it was found that a proactive medication safety surveillance system can be used on a national level to identify adverse outcomes and events in different settings of care that are associated with selected medications.

Ntrypoint Media aims to gather the world’s life experiences as a means to promote social change in healthcare. Ntrypoint Media is different because we provide social change media through a brand of “personal lifestyle records,” capable of converting social networkers into change agents by recording not only health information but complete experiences about how they live, work and play in any setting. Active contributors who accumulate “social credits” are rewarded with free or low-cost products and services donated by our exclusive network of for-profit and non-profit partners.