A Closing Thought: Prescribing Fixes for a Broken System
Applied Clinical Trials
Arthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics, expressed his frank views about issues that are ailing the drug industry today during his DIA Keynote Address in mid-June.
Arthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics, expressed his frank views about issues that are ailing the drug industry today during his DIA Keynote Address in mid-June.
He began by recounting the circumstances surrounding the well-known 1999 death of Jesse Gelsinger, a subject in a gene therapy trial of a drug to treat OTC deficiency-a rare metabolic disease that prevents the body from properly processing protein and which is frequently fatal in infants.
Attendees exchanging ideas at DIAs 40th Annual Meeting, held at the Washington Convention Center in DC.
Caplan conceded that there were problems connected with the University of Pennsylvania trial, even though two separate IRBs as well as the NIH were involved. He also emphasized that although both the lead scientist and the university had possible conflicts of interests, they were nonetheless motivated to "save babies and do good."
Pointing to such issues as poor informed consent, ineffective peer review, and conflicts of interest, Caplan suggested several steps to help fix a " broken system ."
First, he says, the industry must do a better job collecting basic data on human subjects and adhering to accepted GCP protocols during clinical trials. "We have better data on animals than we have on people," Caplan lamented.
Attendees exchanging ideas at DIA's 40th Annual Meeting, held at the Washington Convention Center in DC.
Second, he advocates splitting the functions of the IRBs and DSMBs. Ethics committees, he argues, are overwhelmed and should focus on monitoring informed consent while the DSMBs should oversee data compliance. To better utilize IRB resources, Caplan favors increased audits at pivotal trials and fewer, more random audits in low-risk studies. When problems are uncovered in less critical trials, however, he says there should be heavier sanctions levied.
Third, Caplan favors creation of a central registry of adverse events: "Disclosure is great; transparency is greater."
Attendees exchanging ideas at DIAs 40th Annual Meeting, held at the Washington Convention Center in DC.
Finally, he believes a flexible, worldwide compensation policy for payouts to those affected by adverse events would help, cautioning, " One size does not fit all ."
It would be unrealistic to believe Caplan's solutions will be implemented in the near term. Nevertheless, these issues provide for provocative discussion in the ongoing dialogue over stronger subject protections in clinical trials.-Rob Davidson
Guidelines for Obtaining Informed Consent for Clinical Research
November 2nd 2003Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.
A Clinical Development Solution Tailored for Biopharmaceutical Companies
November 1st 2003The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).
Recruitment Rates and Data Quality -- Are They Linked?
November 1st 2003Clinical trials sponsors seek quick subject enrollment and high data quality, expressed by both strict adherence to good clinical practice (GCP) requirements and completeness and correctness of the data collected from investigative sites. However, the most informative sources of detailed information on data quality such as site monitoring visit reports, sponsor, and CRO audit reports are maintained as strictly confidential documents and are not publicly disseminated. Therefore, a substantial proportion of the information on data quality in clinical research that is available to the general public is based on anecdotal reports rather than well-referenced and organized observations. The U.S. Food and Drug Administration found no evidence of poor GCP compliance during inspections in the emerging clinical research countries, including Eastern Europe and the former Soviet Union.1-2
