George Weiner, MD
Professor of Internal Medicine and Director of the Holden Comprehensive Cancer Center at the University of Iowa, Chair, ASH Committee on Government Affairs
Clinical research in hematology has never been more important, yet clinical investigators are facing unprecedented challenges. Constantly changing (and at times inconsistent) regulations, chaotic reimbursement policies, increasing demands on physician time, and scientific advances demonstrating the complex differences among individual patients all complicate hematology clinical research.
The opportunities and obstacles are not unique to hematology and include problems with how we organize, support, and conduct clinical research. These are starting to receive considerable attention. The Institute of Medicine (IOM) recently released a report that calls for an overhaul of the National Cancer Institute’s (NCI) Cooperative Group Program. The report1 identifies four overarching goals:
• Improving the speed and efficiency of the design, launch, and conduct of clinical trials
• Making optimal use of scientific innovations
• Improving selection, prioritization, support, and completion of clinical trials
• Fostering expanded participation of both physicians and patients in clinical research
These are all vital issues, and addressing these goals is important for all aspects of clinical hematology research, not just those studies that are part of the NCI cooperative groups. An excellent summary of this report was recently published in the New England Journal of Medicine by Robert Young.2
The issue of clinical trials for both malignant and non-malignant hematologic diseases and conditions is a priority for the Society. ASH has consistently advocated for Medicare and private insurer coverage of routine patient costs associated with clinical trial participation. Most recently, ASH supported a provision included in health reform that requires coverage of routine patient costs associated with clinical trial participation and prohibits insurers from dropping coverage because an individual chooses to participate in a clinical trial. ASH has also advocated for legislative language that encourages the Department of Health and Human Services to determine if changes could be made to better harmonize the federal policies and regulations on clinical trial operations that currently exists at various federal agencies, which has the potential to expedite the initiation of new trials and access to promising treatments for patients.
At the same time, let’s not forget that at the heart of clinical research is the interaction between the physician and patient. We need to take a long, careful look at what we can do to improve the efficiency of the aspect of the clinical research process that takes place in the exam rooms of hematologists and other clinical investigators across the country.
An idea came to mind recently, when I came across a 30-year-old informed consent document. It was clear, concise, and short — in marked contrast to informed consent documents we use today. Our current consents have multiple pages of text to protect the institution and the sponsor, not the subject. Indeed, physicians involved in clinical research know how difficult it is to convince potential subjects to read and understand long and complex informed consent documents. Clearer, shorter, simpler informed consent documents would be easier for clinical investigators to present to potential subjects, easier for those potential subjects to understand, and better at protecting the rights of the subjects. They would result in enhanced accrual to clinical trials.
The IOM is to be commended for their thoughtful and forward-looking approach to how our nation’s clinical research leaders select, prioritize, and support clinical trials. However, changing how we organize clinical research in the governmental conference rooms is not enough. We also need to consider how we can improve the vital part of clinical research that takes place in the exam room. It is time to consider ways we can revise the informed consent process to make documents simpler and more efficient. This will be a difficult and complex discussion, but with careful thought we can improve the efficiency of the informed consent process, enhance accrual, and at the same time do a better job protecting the rights of patients.
A national cancer clinical trials system for the 21st century: reinvigorating the NCI cooperative group program. Report. Institute of Medicine. April 15, 2010.
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