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Duke co-founds new initiative that will revamp clinical trials

As a forerunner in medical research, Duke is leading a new initiative to reform and regulate clinical trials.

The Clinical Trial Transformation Initiative—a public-private partnership that includes more than 60 organizations—has put forward suggestions to combat inefficiency and costliness associated with clinical trials. Duke is a co-founder of the CTTI, alongside the Food and Drug Administration. Because the FDA cannot legally house public-private partnerships, Duke convenes the group’s meetings and handles finances, said Robert Califf, co-chair of the CTTI executive committee and vice chancellor for clinical research.

“Clinical trials exist in a complex ecosystem, so a lot of aspects need to change at the same time in order to really make progress,” Califf said. “Because of the broad participation, we have a very good chance of making a difference.”

The initiative’s first set of recommendations address the manner in which clinical trials are conducted. The suggestions aim to ensure higher levels of quality through effective monitoring and to improve the safety of clinical trials.

Clinical trials are used to test new drugs, devices and biological products as quickly as possible, according to CTTI’s website. The organization says it believes that randomized clinical trials are the best way to gather unbiased information on improvements in medical care, and that the current system is “paper-based, slow and costly.”

“The problem is that clinical trials have gotten to be so complex and expensive,” CTTI Executive Director Judith Kramer said. “The number of trials you can do is pretty small due to the price, and as they get longer and more burdensome to complete, people are starting to look at other sources of information.”

Making trials more efficient is important, Kramer added, because clinical trials remain the “most unbiased way to get evidence about the effectiveness of [medical] products.”

Junior Willie Zhang hopes to do medical research in his future, and said he has heard that clinical trials can be inefficient.

“I’ve heard doctors complain about clinical trials before because of their inefficiency,” he said. “I think change is long overdue.”

Although the University plays an important role, the coalition is broad and includes not only academic institutions but also government agencies, pharmaceutical companies, contract research organizations, patient advocacy groups and law firms, Califf added.

Kramer said the number of organizations taking part in the coalition is growing every day, simply by word of mouth.

“It’s really been interesting,” she said. “We haven’t done a lot of marketing—in fact, I would say [we have done] almost none.... We’ve been very fortunate to be doing enough that people are aware of what’s happening and interested in participating.”

Califf said he believes the initiative has potential because of growing concerns about the high cost, low success rate and uncertainty surrounding clinical trials.

“The time is right to make a major improvement in the way clinical trials are done,” Califf said. “Drugs and devices can be developed more efficiently and the public can rest assured that we understand the balance of benefits and risks of marketed products.”

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