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PATIENT CONCERNS
Patients in clinical trials sometimes express concern that they might be receiving inferior treatment if they learn that they were receiving the placebo and not the experimental drug being tested. They also worry that the “new” therapy might not be as good as the standard treatment for their disease. However, trials are designed both to avoid the use of an inferior treatment and to determine the best treatment. Clinical trials have built in periodic checks and balances that constantly monitor and analyze patient progress. If one group is determined to be doing significantly better than another group in a phase III trial, the trial is discontinued, and in some cases patients are offered the more effective medication or treatment. This is because the new treatment has demonstrated superiority to previous treatments early on. Likewise, if a particular treatment has shown that the risks outweigh the potential benefit, the study is terminated. In addition, new treatments sometimes look promising in a Phase II study, based on past nonstudy patient experiences, but when all patients in a Phase III trial are analyzed, the results indicate that those who did not receive the new treatment did as well as those who did receive it.
Furthermore, patients who participate in clinical trials often have a better outcome simply because they are participating in a trial. The explanation may be that these patients are seen by health care providers more frequently and are monitored even more closely than they would have been otherwise. Not only are their physicians, nurses, and others closely observing their progress, the company sponsoring the research regularly reviews their medical information and alerts the health care team to any problems they might find. These advantageous aspects of participating in a trial are important to explain to patients who may worry a great deal over their inability to control which treatment they receive.
Many patients ask about insurance reimbursement for coverage of clinical trials. They fear that insurance providers will consider the trial experimental and will not reimburse the physician or other health care providers for the therapy. Medicare has recently begun to cover clinical trials, and other third-party payers have found it is actually beneficial to support participation in clinical trials to achieve better and potentially less expensive outcomes.5 It is unusual today for any type of health care provider to decline reimbursement to a patient participating in a clinical trial. Patients should also be reassured that approval from their insurance will be secured before they proceed with the study. Furthermore, treatments or medications that are not FDA-approved and cannot be billed for are typically covered by the sponsors of the study.
HIPAA (Health Insurance Portability and Accountability Act) regulations have raised concerns among those involved in cancer research about how to adhere to HIPAA rules and regulations while remaining involved in cancer clinical trials. HIPPA rules have adversely affected interactions between research institutions (such as by making data sharing more difficult) and have added an extra layer of bureaucracy and regulation.6
FUNDING CLINICAL TRIALS
Most of the money spent on cancer research in both the United States and Europe is spent primarily on studying the biology or mechanisms of cancer. Lesser amounts are spent on the development of new clinical treatments to be tested in patients and on the establishment of measures to prevent the development of cancer. The difference between the funding of cancer research in the United States and in Europe is dramatic, however. The United States spends several times more per person on cancer research than does any of the wealthiest nations in Europe.7 The causes for this disparity may be rooted in the different health care systems in the various countries and in the amount of nongovernment funds available for research.
The amounts various countries spend on cancer research may seem to be less important in today’s world of rapid communication and information sharing. It remains true, however, that countries with more active research programs tend to provide improved cancer treatments more rapidly to the community of patients. The United States should be proud of our activity in the fight against cancer and our contribution to this area of medicine.
The world also owes a debt of gratitude to the cancer patients who participate in clinical trials. While these patients generally do so in hope for a better outcome for themselves, they also are contributing information to oncology research that will benefit future cancer patients. Their altruism has allowed many cancers to be cured and most to become manageable diseases. ONA
Donald Fleming is an oncologist at the Cancer Care Center, Davis Memorial Hospital, Elkins, West Virginia, and a member of the Oncology Nurse Advisor editorial board.
References
1. Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009;101(10):708-720.
2. Sonpavde G, Galsky MD, Hutson TE, Von Hoff DD. Patient selection for phase II trials. Am J Clin Oncol. 2009 ;32(2):216-219.
3. Stanley K. Design of randomized controlled trials. Circulation. 2007;115(9):1164-1169.
4. Freidlin B, Korn EL, Gray R, Martin A. Multi-arm clinical trials of new agents: some design considerations. Clin Cancer Res. 2008;14(14):4368-4371.
5. Barnes M, Korn J. Medicare reimbursement for clinical trial services: understanding Medicare coverage in establishing a clinical trial budget. J Health Law. 2005;38(4):609-631.
6. Harrelson JM, Falletta JM. The privacy rule (HIPAA) as it relates to clinical research. Cancer Treat Res. 2007;132:199-207.
7. Illman J. Cancer research funding in Europe low compared with U.S., survey finds. J Natl Cancer Inst. 2005;97(10):713-714.
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