Patient Indemnification on Clinical Trials Paplauskas,Leonard 11 Jul 2001 10:48 EST
At the University of Connecticut Health Center, it has been our policy to insist that sponsors of investigational drug/device trials agree to reimburse subjects for medical care costs associated with injuries sustained as a result of participating in the clinical trial. In most cases, the sponsors agree to cover all costs which the subject's medical insurance will not cover. According to the Reuters article shown below, the insurance industry may be increasing the cost of providing such indemnification to clinical trial sponsors, and the result could be that arranging for such coverage in clinical trial agreements will be more difficult in the future. I am trying to collect information on this issue in preparation for an evaluation of our policy, and would very much like to hear from other institutions as to their policies on this matter. Leonard P. Paplauskas Associate Vice President for Research Administration University of Connecticut Health Center ASB-3, MC5355 Farmington, CT 06030-5355 xxxxxx@adp.uchc.edu (external e-mail) xxxxxx@exchange.uchc.edu (internal e-mail) 860-679-3173 (phone) 860-679-2670 (fax) ***************************** Insurance Companies Get Stricter on Clinical Trials By Kate Fodor SAN DIEGO (Reuters Health) - In preparation for what the insurance industry believes will be a marked increase in the number of lawsuits filed by subjects in drug and device trials over the next few years, underwriters are tightening up their requirements for companies seeking coverage of clinical trials, Chubb Insurance Life Sciences Casualty Manager Jill Wadlund said during an interview with Reuters Health. While litigation is not uncommon after a drug is approved, lawsuits involving clinical trials appear to be increasing, said Wadlund, who is slated to speak at the Biotechnology Industry Organization convention here on Tuesday. ``Litigation in the clinical trial area is definitely already on the upswing,'' and, for a number of reasons, Chubb believes the trend is likely to continue. ``For a very long time, there wasn't much litigation...but there are many more trials going on and the trials have gotten more complex,'' Wadlund explained. Simply put, more trials mean more opportunities for lawsuits. Several high-profile suits--including the one filed by the family of Jesse Gelsinger, who died in 1999 in a gene therapy trial at the University of Pennsylvania--have recently alerted trial participants and plaintiffs' attorneys to the potential for litigation, Wadlund noted. ``In the past, plaintiffs' attorneys didn't see a huge opportunity there,'' she said. ``Now, with all the media attention, they pay more attention to it...Some plaintiffs' attorneys have actually set up litigation units for clinical trials; that's how seriously they're taking it. And they will look where they may not have bothered to look before. ``Some new things that are coming up include what they are calling dignity harm,'' or a violation of human dignity as established by the Nuremberg Code and the Declaration of Helsinki, she said. Companies are also vulnerable to complaints from subjects who lose access to therapies they believe have been successful. ``When a study ends, maybe the company has established provisions for compassionate use and maybe they haven't--and you'll get lawsuits for not providing access to the drug,'' Wadlund said. ``You'll also get lawsuits where subjects didn't know they could be expelled from a study. The investigators might really think a patient needs to exit the program for his own safety, but the patient doesn't see it that way.'' In addition, recruitment techniques are under increased scrutiny, and companies must be careful not to leave themselves open to charges that they provided ``too much temptation'' to enrollees, either through monetary incentives or overblown promises about a therapy's efficacy. In general, given the new legal climate, companies and individuals need to be willing to rethink their established methods, she added. ``We're looking for willingness to be open to the idea that maybe you could do some things to tighten up your practices...If not, we're either going to decide to cover you at a much higher price and on much more restrictive terms or not to offer you coverage at all.'' ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================