By Kim Coghill
WASHINGTON ¿ Adverse and other unexpected events over the last several years, including the death of gene therapy patient Jesse Gelsinger, have led to an increased interest in clinical trials by the federal government.
And a panel of experts who spoke in Washington Thursday at the 44th Annual Educational Conference sponsored by the Food and Drug Law Institute agreed that the government¿s interest isn¿t expected to wane anytime soon.
Simply put, Greg Koski, director of the federal Office for Human Research Protections (OHRP), said, regarding clinical trials, ¿If you can¿t do it right, don¿t do it at all.¿ His office, which falls under the auspices of the Department of Health and Human Services, doesn¿t really care whether a major academic institution, a small company or a large company is conducting research ¿ uniform standards of conduct and regulation must apply equally.
¿We absolutely must have the confidence of volunteers who participate in human trials and the public,¿ he said.
Koski¿s office was created under the Clinton administration by former secretary of Health and Human Services Donna Shalala. It was the passing problems with clinical trials, like the death of Gelsinger, which prompted the Clinton team to begin reviewing ways of better ensuring the health and safety of the public.
Gelsinger, 18, was a participant in a University of Pennsylvania Phase I gene therapy study for patients with ornithine transcarbamylase deficiency. He died in September 1999, days after receiving a hepatic infusion of an altered adenoviral vector.
But Koski said his office wasn¿t built to add layers of regulations to those conducting clinical trials. Instead, OHRP¿s charge is to make existing rules and regulations work more efficiently.
Michael Werner, the Biotechnology Industry Organization¿s director of federal government relations and bioethics counsel, and a conference panelist, said, ¿Federal policy must protect research participants, but also must allow this critical research to continue. And from BIO¿s perspective, those are not mutually exclusive. To the contrary, those are mutually attainable goals. We can provide meaningful protection for people who participate in trials and do it in a way that we can allow this research to go forward so that it will in fact get to the ultimate goal, which is development of cures and treatment for disease.¿
Other than the safety of patients, including reporting of errors and misconduct, Koski said areas of concern among government agencies and those within the industry alike include the ¿inherent¿ financial or conflicts of interest aspects of clinical trials.
Stuart Nightingale, senior medical adviser to the assistant secretary for planning and evaluation in the Department of Health and Human Services, and a conference panelist, said despite some FDA regulations, currently there is no uniform, comprehensive approach to consideration of potential financial conflict of interest in human research. However, an HHS study has shown that about one-fourth of institutional review boards are considering financial arrangements with sponsors of research to varying extents, he said. Some include disclosures about financial relationships in consent forms.
Last May, Nightingale said Shalala announced initiatives to strengthen human subject protection, and among them was a rule to develop guidance on financial conflict of interest that would further protect research participants.
¿Clear demonstration by sponsors, institutions and investigators to potential subjects that conflicts are being eliminated or effectively managed when possible can help to develop a stronger bond of trust with the subjects and the public,¿ Nightingale said.
Potential or existing conflicts of interest should initially be dealt with by changing protocol and modifying consent documents, he said. When a conflict cannot be eliminated, either on the part of the clinical investigator or institution, Nightingale said the arrangement should be disclosed on the consent document.