Public Engagement and Clinical Trials New Models and Disruptive Technologies: Workshop Summary (2012) / Chapter Skim
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3 Recruitment Challenges in Clinical Trials for Different Diseases and Conditions
3 Recruitment Challenges in Clinical Trials for Different Diseases and Conditions
Pages 17-30
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From page 17... ...
Many workshop presenters emphasized that patients worry about a great number of issues, their health being only one of them, and every aspect of a trial protocol that makes it harder to understand, less relevant to them, and less convenient diminishes the likelihood of participation. CARDIOVASCULAR SURGERY1 From an institutional and investigator perspective, not meeting enrollment numbers in a timely way can cause a clinical trial to lose momentum and can lead to other negative conditions such as investiga tor burnout.
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From page 18... ...
From the investigator's perspective, then, patient recruitment is a significant responsibility and not doing it effectively may lead to frustration, institutional concern, and even embarrassment. Three major clinical trials in which Robert Michler, Surgeon-in-Chief, Professor and Chairman, and Director, Center for Heart and Vascular Care at the Montefiore Medical Center/Albert Einstein College of Medicine, actively participated all involved patients with serious heart disease for which surgery was a treatment alternative: Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)
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in patients with left ventricle dysfunction is better than CABG alone. 5 The alternative treatments for mitral valve disease in the CTSN moderate ischemic mi tral regurgitation trial are CABG surgery with mitral valve repair versus CABG alone (300 patients)
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When patients are in the communication loop during and after their participation in a clinical trial, this can increase positive feelings associated with trial participation and convey that their contribution was of value. A workshop participant also noted that some people who drop out of clinical trials are convinced to do so by a family member who is a health professional -- a physician, pharmacist, or nurse.
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"For that, we need help from insiders," Carol Horowitz, Associate Professor, Department of Health Evidence and Pol 6 Based on the presentation by Carol Horowitz, Associate Professor, Department of Health Evidence and Policy, Mount Sinai School of Medicine.
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. a Based on the presentation by Robert Michler, Surgeon-in-Chief, Professor and Chairman, and Director, Center for Heart and Vascular Care at the Montefiore Medical Center/Albert Einstein College of Medicine.
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From page 23... ...
This requires involvement with all those directly and indirectly affected by and involved in the trial: com munities of patients, their clinicians, leaders of community organizations, and local opinion leaders. The latter are the hubs for social networks and the cultural insiders and thus are the people who can reach potential participants.
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From page 24... ...
has encouraged the development of CBPR, presenter Nina A Bickell, Director, Center to Achieve and Sustain Health in Harlem, Mount Sinai School of Medicine, responded, and NIH funded the prediabetes grant Horowitz described for the workshop (see the case study on prediabetes care in the next section)
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From page 25... ...
The community partners developed the following recruitment strategies: 9 Resolving infrastructure issues in academic medicine has been one of the concerns of the NIH-funded CTSA consortium and its 60 participating academic medical research institutes. In late 2010, NIH announced plans for a new $722 million National Center for Advancing Translational Sciences (NCATS)
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From page 26... ...
Throughout, the researchers worked to create an upbeat environment at the study site that would make participants feel welcome and part of the team. As the researchers routinely told study participants, "This is brought to you by you." Case Study: Continuity of Breast Cancer Care10 An example of a trial exploring continuity of breast cancer care was presented to illustrate strategies for engagement of physicians in clinical trials.
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MENTAL HEALTH12 Sixty years ago, clinical trials on the first drugs to treat schizophrenia and depression found such robust positive effects that the studies could be conducted with small numbers of patients. In recent decades, the situation has changed dramatically, said Kenneth Davis, President and CEO, Mount Sinai Medical Center and Professor of Psychiatry, Mount Sinai School of Medicine.
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Or, as workshop participant Michael Parides, Professor of Biostatistics, Department of Health Evidence and Policy, Mount Sinai School of Medicine, suggested, the design of confirmatory trials might be flawed due to weaknesses in the design and objectives of early-phase trials. Several recent trends have changed the research environment.
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Davis said these laws will have to be reconsidered if they are to best meet public health needs and enable real clinical breakthroughs for treatment -- and especially prevention -- of psychiatric conditions.
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