July 29

High Mortality Rates in Clinical Trials

High Mortality Rates in Clinical Trials

Mon, 4 Nov 2002

Serious concerns are being raised about the high death rate in clinical trials. According to several articles in the American Journal of Respiratory and Critical Care Medicine, the lives of critically ill patients have been put at increased risk due to flaws in the research design and inadequate toxicity monitoring of patients.

Scientists from Washington University (St Louis) and the NIH, compared mortality rates of critically ill patients who participated in clinical trials at major research centers. They found that those who were exposed to the experimental treatment had exceedingly high mortality rates compared with patients in the control group who received standard care.

For example, a phase III trial(532 pts) testing human growth hormone: 42 patients treated with the experimental HGH died compared with 19 in the control group. In another phase III trial (112 pts)testing substitute blood (DCLHb): 46 patients treated with DCLHb died compared with 17 in the control group. Of particular note: this study was the first one conducted implementing the FDA’s new policy allowing waiver of informed consent in emergency care. The mortality rate in the study demonstrates why the policy is unethical–had the patients been given a choice, many would have lived.

[See: Bradley D, et al, “Safeguarding Patients in Clinical Trials with High Mortality Rates,” AJRCCM, 2001, vol 164, pp. 190-192 http://ajrccm.atsjournals.org/cgi/content/full/164/2/190]

On July 29, 2002, the Alliance for Human Research Protection (AHRP) filed a complaint with the Office of Human Research Protections about an acute respiratory distress syndrome study (ARDS)that had been conducted without valid informed consent–in which the death toll had reached 305 before the study was suspended. [See: complaint filed with OHRP, On July 29, 2002. http://www.researchprotection.org/ethical/Koski0729.php.]

The ARDS study was also criticized by critical care experts at NIH for failing to provide these critically ill patients with the best currently available standard of treatment–and thereby increasing the mortality rate. See: Eichacker, et al, “A Metaanalysis of ALI and ARDS Trials Testing Low Tidal Volumes” AJRCCM http://ajrccm.atsjournals.org/cgi/search?fulltext=eichacker&volume=166&issue=11&journalcode=ajrccm

It is clear that federal oversight agencies–both the FDA and OHRP– have an immediate responsibility to examine the charts of patients who died while participating in clinical trials. The death rate in these trials needs to be compared to the mortality rates for similarly ill patients who received standard community care. The public has a right to know!

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