Trends to Watch
Patients Take Lead in Creating 'Virtual' Drug Development Groups
A story in the July 29 Wall Street Journal discussed how patients are using technology and the online community to find new ways to support the development of new treatments and drugs to deal with a wide range of diseases. A “virtual drug development” organization has been set up to explore new avenues to deal with melanoma spurred on by an Internet entrepreneur who was diagnosed with the disease. The story details how Dr. Jay M. Tenenbaum, after learning his melanoma had relapsed in 2003 and spread to his liver, worked to find new therapies. In his search, he found a number of researchers, doctors, and groups with promising ideas but what he did not find was a single resource area where these ideas were being brought together. That’s when the Internet entrepreneur used his expertise to develop what the Journal described as “a company aimed at helping patients develop new therapies faster and cheaper for less common diseases, like melanoma, that often don't attract major pharmaceutical company research funding.”
The company - CollabRx - aims to expand patient-funded research further by connecting individuals or small numbers of patients with people who have the expertise and new services and treatments that apply to their specific need. Patients work with a CollabRx-assigned project manager to devise a research strategy, interpret the results and later steer any promising prospects toward development of possible treatments. The Journal notes that CollabRx “taps into the recent phenomenon of patient-supported research — a trend largely driven by people wealthy enough to help fund drug-discovery projects and who are affected by rare or overlooked diseases.” Dr. Tenenbaum noted that CollabRx's fees vary according to the scope of a project but clients can expect to pay for drug screens, clinical trials, and the costs of other contracted services. They will also pay CollabRx a management fee of 10% of a project's budget and the organization will receive a 20% share of any intellectual property that emerges from the project.
FDA Proposes Annual Clinical Trial Safety Reports, Comments Due Oct. 6
On August 5, the Food and Drug Administration issued a proposed guideline that would ask clinical trial sponsors to submit annual development safety update reports (DSURs) to the agency. This proposed guidance is designed to match one issued previously by the International Conference on Harmonisation (ICH). According to the FDA, the reports would replace those used now to ensure the safety of drugs in clinical trials, such as the IND Annual Report. In a DSUR, sponsors are supposed to update the trial’s status, summarize their understanding and management of identified and potential risks, describe new safety concerns that could affect the protection of trial subjects and examine whether the information collected during the previous year fits with knowledge about the product’s safety, the draft says.
Sponsors are advised to include other findings that affect subject safety, according to the draft. Those findings may come from nonclinical studies, related clinical trials conducted by the sponsor’s development partners and non-interventional or compassionate-use studies. Some of the information expected in a DSUR — based on safety findings, serious adverse reactions and relevant published articles — may be provided in the sponsor’s periodic safety updates for marketed products involved in current clinical trials, the draft says. The draft can be viewed in full at this website. Comments are due Oct. 6.
Major Vytorin Study Shows No Effect on Cardiovascular Events
First results of a clinical trial into a popular cholesterol-lowering drug found that it did not prevent worsening of cardiovascular disease or lower the need for valve surgery than a placebo. A July 21 report from the Associated Press noted that the findings on a just-completed study of Vytorin, marketed jointly by Merck and Schering-Plough that the drug was no better than placebo at lowering the risk of major cardiovascular events — including heart attack, stroke, heart surgery and death — in patients with a aortic stenosis, which involves partial blockage and stiffening of the aortic valve. Vytorin did lower cholesterol in the tests but did not protect patients’ heart valves.
The study of more than 1,800 patients which ended in March is the second major clinical trial that has cut into the highly-publicized drug’s reputation. Earlier this year, a long-delayed study called ENHANCE found that Vytorin was no better at reducing plaque buildup than the lower-priced generic drug Zocor, which has been on sale for two years. Also, the conduct of this particular clinical trial has drawn the interest of Congressional investigators who are looking into allegations that the companies deliberately delayed releasing that data to prop up sales of Vytorin.