I am considering enrolling in

by francine Hardaway on May 16, 2006

I am considering enrolling in a clinical trial for a new osteoarthritis treatment. I don�t even know what the new treatment is yet, but I know I have osteoarthritis in my hip and I�m of a �certain age,� so they want me in the study. A research lab will give me a bunch of free diagnostic tests, and Novartis, the sponsor of the trial, will pay me $250.00 if I participate.

The money is obviously insignificant; the time involved may be more costly than the remuneration. And fortunately, I have health insurance and can get medical tests on my own if I need them.

So why would I even consider participating? Because somebody has to.

It is getting more and more difficult to get people into clinical trials, and more and more costly to develop new meds. This coincides with theoretically greater need for new therapies as the Boomers age and make their demands on the system.

Back in the day, clinical trials were carried out on prisoners, pacifists, and other captive populations who sometimes didn�t even know they were participating in a trial. Only thirty years later, when a group of people develops a weird-ass disease, do we learn that they were exposed to XYZ chemical in the Army has part of some trial.

But now it�s all different, and getting more so every day. The FDA is currently under a great deal of scrutiny. Last year was a banner year for screw-ups, with the recall of the Cox-2 inhibitors after they passed FDA approval and were in widespread use, and the �black box� warning that now must accompany anti-depressants prescribed for teen-agers to alert parents to the increased suicide risk. And just this morning I heard that Paxil, a common anti-depressant my late husband took a decade ago, has now been found to increase suicide risk in adults.

Every one of these incidents (and you can add the one in the UK, in which four patients in a clinical trial died recently) leads to Congressional hearings and greater concern on the part of the public. Apparently, a survey taken of the FDA�s own employees revealed that even THEY thought the agency was not giving enough attention to public health in its efforts to rush new drugs to market.

According to Laurie Halloran, a biotech consultant whose speech made me begin thinking about these issues, there has been quite a productivity gap in new drug development recently. Despite advances in science, the success rate of product development has NOT improved. New compounds entering Phase 1 development today have an 8% chance of reaching the market versus 14% chance 15 years ago
Phase 3 failure rates are now reported as high as 50% versus 20% in Phase 3, 10 years ago.

And when they get to market (Phase IV), there are clearly some surprises � enough to make the public skeptical about participating in trials unless they are terminal.

Laurie�s point (I hope I�m right because I�m learning all this from her) is that the process for drug development must be improved all along the product development cycle. The small biotech companies that typically contain scientists without management teams or clinical experience must change; the research sites that conduct the trials must change; and the FDA�s regulatory processes must change.

Change is good. But it�s not without struggle. We are not going to fix this process for getting drugs to market overnight. Even though we need the results in a hurry.

We have to train more American clinicians and research sites to conduct trials, and to gather what�s known as �good� data. Good data is accurate, it�s legal (the patient has signed an �informed consent,�) and it is collected from the right demographic.
We also have to find better ways to sponsor (which means pay for) these trials: right now they are fraught with potential conflicts of interest. The drug companies pay for them. That says it all. There are only seven pharmaceutical companies left � the result of half a century of mergers and acquisitions. That�s why the industry is called �Big Pharma.�

But most of all, we have to find ways to bring the innovative products of small biotech companies to the clinical trial stage. What does it take? It takes clinical experience, expertise in product development, patience (about ten years), patients willing to enroll in the trials, and MONEY.

I�m doing my part. I�m donating my body to science.

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