The Lynx Group

Community Trials Essential to Broad Knowledge

September 2010, Vol 1, No 4
Ed Pezalla, MD, MPH
CEO, Enlightenment Bioconsult
Wethersfield, CT

Several sessions at the recent ASCO meeting considered new standards for community-based oncology research and the development of comparative effectiveness research (CER) methods.

Community-based oncology trials play an important role in developing treatment strategies and options. In recent years, however, clinical trial participation in the United States has been on the decline, which limits the population available to researchers and makes it difficult to achieve the diversity needed to reflect the actual experience of patients across the country. Encouraging high-quality community-based trials will remedy this and remove barriers such as the need to travel to major urban medical centers.

Problems of cost will continue to exist but we should note that for manufacturer-sponsored drug trials, the pharmaceutical firm will cover the cost of the experimental treatment and most insurers will cover the routine care needed for the treatment of cancer. In all cases, however, guidance from the health plan on reimbursement should be sought before enrolling in a trial. This may not make trial participation affordable for all but should go some ways towards helping many more patients join a trial. In addition, with the passage of the Patient Protection and Affordable Care Act in March 2010, insurers will be prohibited from dropping or limiting coverage because an individual chooses to participate in a clinical trial effective January 1, 2014. This applies to all clinical trials that treat cancer or other life-threatening diseases.

As noted in “Trial Participation Hampered by Costs” (see page 11), patients continue to express concerns about the cost of clinical trial participation, and Dr Weckstein’s prescriptions for mitigating these financial barriers appear sound. Covering the largely unseen costs of copays and deductibles through legislation would be a huge boon, as would public funding for patient costs associated with trial participation.

The development of sophisticated CER methodologies should also help to fill the gap for clinical trials since these approaches may augment, or in some cases, replace, the need for an expensive randomized controlled trial (RCT).

It is my hope that a combination of renewed interest in clinical trials at the community level with alternatives to RCTs in the case of already approved drugs will yield better medical evidence and better patient outcomes.

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