New project to boost patient participation in US trials

By Emilie Reymond

- Last updated on GMT

Related tags: Clinical trial

Two US universities have teamed up to develop a new project
aimed to boost patient participation in clinical trials.

Weill Cornell Medical College in New York City and the Cornell University College of Agriculture and Life Sciences in Ithaca, New York, have launched a collaborative study called IMPACT (Improving Methods for Patient Accrual to Clinical Trials) in a bid to better understand and improve such patient participation. Patient recruitment is now consuming thirty per cent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. Finding these patients is often difficult as individuals may be unaware of clinical studies, and other hurdles may also put them off. These delays are costing drug companies over half a million dollars for specialty products and more than $8m (€6.7m) for blockbuster brands in lost sales and are also causing the cost of running clinical trials to skyrocket. The new IMPACT scheme will initially focus on cancer where participation rates are particularly low. According to the Weill Cornell Medical College, one of the two institutions involved in the initiative, less than 2 per cent of patients choose to participate in clinical trials for cancer therapies across the US. "Even a modest increase of 2 to 3 percentage points would make a major impact, meaning the difference between completing a study in two years instead of three,"​ said Dr John Leonard, a co-leader of the IMPACT study and a professor of medicine at Weill Cornell Medical College. IMPACT investigators will collaborate with The Leukemia & Lymphoma Society which has helped finance the first phase of the project, including a national survey on attitudes toward participation in clinical trials. "Hundreds of studies have sought to identify and overcome barriers to enrolment. This project is the first to assess the problem from a socio-psychological perspective, using the specialised methods of risk communication,"​ said Dr Katherine McComas, principal leader of the study and assistant professor at the College of Agriculture and Life Sciences at Cornell, the second university at the origin of the project. In practice, she said, the study will be using two approaches - the model of Risk Information Seeking and Processing (RISP) and Theory of Planned Behaviour - in order to examine specific factors that influence how patients inform themselves about a clinical trial and decide to participate. According to previous research, several obstacles contribute to low patient partipation in clinical studies include patient's fear of randomisation and risk of side effects; lack of trust in physicians and researchers; time commitment and other logistical concerns; and a lack of familiarity with clinical trials. On the other hand, patients may choose to participate in clinical trials because they perceive potential for a better treatment, reduced treatment cost and feelings of altruism. According to the '2007 CenterWatch National Survey of Study Volunteers', presented at the Drug Information Association (DIA) conference in Atlanta in June, the most popular motivation for patients to participate in clinical trials was "to help myself and others/ to advance science" (81 per cent); "to find a better treatment" (75 per cent) coming in closely behind, followed by "to receive higher quality medical care" (51 per cent). Meanwhile, the IMPACT initiative is one of several recent efforts at Weill Cornell Medical College to foster clinical research programmes across the medical spectrum, including the development of the Institute for Clinical Research. "Our aim is to provide data-supported recommendations for strategies to improve the accrual of patients in clinical trials,"​ said Dr Andrew Dannenberg, also a co-leader of the IMPACT project, from the Weill Cornell Medical College. "Future phases of the study will develop specific tools to better inform patients, educate them as to the pros and cons of enrolling in clinical trials, as well as create strategies to facilitate participation."

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