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Controlling for quality in clinical trials

CARNEGIE MELLON (US)—Scientists and regulators alike often focus on how individual patients should be protected from risk and as a result, overlook how medical advance itself can be negatively affected by poorly designed clinical trials, a new study reports.

“Right now, ethical oversight is highly focused on protecting research participants and giving individuals access to scientific developments,” says Alex John London, associate professor of philosophy at Carnegie Mellon University.

“These are important issues. But ethical oversight needs to also ensure that decisions about launching human testing are based on a range of considerations that are not easily captured in the current focus.”

For the past few decades, London says, numerous highly innovative therapies have been introduced into human testing, including genetic-based approaches, stem cells treatments, and therapies aimed at reprogramming the immune system.

Patients with serious illnesses often flock to these studies in hope of a cure. These studies are often controversial, however, because some scientists and regulators consider them too risky while others suggest it is unethical to deny critically ill patients access to these studies.

In the study, published in Science, London and study coauthors argue that debates over access neglect key ethical issues.

“What is often overlooked,” says Jonathan Kimmelman, associate professor at McGill University, “is that allowing studies of poor scientific quality to proceed potentially undermines the entire scientific enterprise, because they undermine trust, consume scarce research resources, and weaken incentives for medical scientists to perform the best research they can.”

“Clinical research is like a scientific bucket-brigade,” London adds, “where one group of scientists hands knowledge to the next, and they do a trial and hand their results to the next, and a problem with one link in the chain can derail a whole program.”

Implementation of four key questions as studies move from animal to human trials would help safeguard advancement of medical research, the researchers say.

The questions address the impact of the results from preliminary studies and the likelihood that the results from the animal model studies will translate to human trials.  In the article, the authors suggest there are instances when human trials are initiated despite unsatisfactory answers to these questions.

“Without critical feedback between preclinical and clinical investigators, oversight committees and sponsors, experiments lose focus and trials risk failure,” says Marina Emborg, associate professor of medical physics at the University of Wisconsin.“Multilevel cooperation is needed for obtaining meaningful results in translational studies.”

“The knowledge and interventions that science produces are valuable social goods,” London says. “Everyone who cares about medical advance has an interest in preserving the integrity of the process that makes these goods possible.”

More news from Carnegie Mellon University: www.cmu.edu/news/

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