Patient & Clinical Trials
Human clinical trials the only way of evaluating whether new drugs, experimental medical devices, and surgical techniques actually work are critical to medical progress. But researchers are experiencing mounting difficulties finding volunteers: a problem expected to get worse as an increasing number of biotechnology products advance through the pipeline.
Last year alone, between five million and six million people participated in about 80,000 clinical research studies that were conducted in the U.S. More participants will likely be needed in coming years to fulfill safety and efficacy requirements. Recruiting volunteers to participate remains one of the costliest parts of the drug development process.
About 81 percent of all clinical trials are delayed at least one to six months due to difficulties in patient enrollment, with another five percent postponed six months or more, according to CenterWatch.
For drug companies, the cost of these delays is enormous. Reducing the length of a clinical trial by just one month by improving patient recruitment could generate an additional $40 million in sales for an average drug, according to a McKinsey study completed last year.
Many recruitment problems stem largely from a lack of awareness about clinical research studies and how clinical trials are crucial for developing successful drugs. In 2001, a Harris Interactive survey found that 85 percent of cancer patients were either unaware or unsure that participation in a clinical trial was an option.
One reason why some patients do not participate is a lack of trust in the clinical research process. There is also considerable mistrust in the clinical research process on the part of certain racial and ethnic minorities, due to past abuses.
Key Questions:
- What are the most effective incentives to encourage participation in clinical trials?
- Are people who enter clinical trials adequately protected from harm? How can such harm be identified and prevented?
- How should potential patient participants receive the best information about a clinical trial and whether to participate?
- What questions should patients ask to decide whether to participate in a clinical trial?
FasterCures launched the Patients Helping Doctors (PHD) Program to increase understanding of the critical role patients play in research, with the ultimate goal of increasing patient participation in this process. Increased patient involvement in all aspects of health-based research, from clinical trials to epidemiological research, is a key component of this initiative. Another element is increasing the extent to which patients share their medical information and biological specimens with the larger research community. Both issues are critical in speeding the path to new medical solutions.
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