Last month, we discussed patient-reported outcomes and some potential implications of the final FDA guidance on using patient-reported outcomes to validate claims in medical product labeling. I read an interesting blog article today about Foundation Medicine’s plan to genome-sequence every cancer tumor. The blog’s author, Trista Morrison, stated:

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.

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.

A new administration is running things in Washington D.C. and its key priorities are reforms in healthcare, education and energy. Already, over $20 billion in economic stimulus has been earmarked for healthcare.

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.