Clinical research: Conducting a trial

Beginners hoping to initiate and complete a clinical trial must understand the complexities of the process.

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Before Edward Chu entered his fourth year at Icahn School of Medicine at Mount Sinai in New York, he took a 12-month sabbatical to launch his first clinical trial. He wanted to evaluate whether patients using an anti-blood-clotting drug, usually to prevent heart attacks, should stop before general surgery. He thought that if he dedicated himself to the project for 12 months, he could wrap up any loose ends before he graduated in 2013. That was optimistic, to say the least.

Chu admits that his goal — to recruit 200 patients, half of whom would continue taking the drug before surgery while the other half discontinued it — was ambitious for a year-long project. His adviser offered guidance throughout, but the day-to-day logistics were up to Chu.Even with an encouraging adviser, financial support from a Doris Duke Clinical Research Fellowship and access to hundreds of potential participants, planning the trial was far more time-consuming than Chu had expected. All investigators need help from specialists and other partners to embark on a clinical trial, but especially first-timers. Although leading a trial often falls to senior researchers, junior investigators training as physicians or undertaking PhDs can have a major role — especially if they are hoping to make clinical studies a big part of their career. Chu needed assistance at almost every step — from his adviser, support staff such as nurses and research coordinators, biostatisticians, members of regulatory review boards, surgeons and cardiologists. In the end, he had to scale the work back into a pilot study, but the experience taught him a great deal about what it takes to make a trial happen.

First steps

Initiating and sponsoring a clinical trial to generate safety and efficacy data for a drug, diagnostic test, device or therapy protocol is an all-consuming team project. The planning stages, which involve transforming an idea into a detailed protocol, assessing and procuring resources and getting approval to do the study, are almost always more complicated and time consuming than a junior investigator expects. They involve multiple reviews from regulatory agencies, and a sometimes gruelling effort to motivate busy clinicians — who often have little stake in the outcome — and their staff, key collaborators who help to provide access to a pool of patients. All these moving parts require careful orchestration. For a new investigator, each step of a clinical trial represents an important learning experience, says Karen Zier, associate dean for medical-student research at Mount Sinai, who helped to pair Chu with his adviser. These are not lessons that trainees can learn solely from a textbook.

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Tuesday, March 26, 2013