Misconceptions exist in cancer trials
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Most cancer trial participants are confused about the trial’s purpose and treatment involved, including physicians involved in the trials. That’s according to an article appearing in the Nov. 24, 2001 issue of The Lancet. Jane C. Weeks, MD, at the Dana-Farber Cancer Institute in Boston and colleagues surveyed 287 cancer patients who had just enrolled in a clinical trial and 91 providers who had obtained a patient’s consent.1 Of those surveyed, 90% were satisfied with the informed consent process. Additionally, most patients considered themselves to be well informed about the trial. Despite their perception, 74% did not recognize the treatment was considered nonstandard. Furthermore, 70% did not know that the treatment was unproven.
Other findings include:
- 29% of patients did not realize that the treatment benefits were uncertain.
- 25% were unaware that the main purpose of the trial was to benefit future patients.
Increased knowledge about the trial was linked to the following:
- having a college education;
- speaking English only at home;
- when the U.S. National Cancer Institute consent form template was used;
- when forms were read carefully and not signed at the initial trial discussion;
- forms were signed only with a nurse present.
"As physicians, we need to be clear, in our own heads, about the real goal of clinical trials and be sure we communicate that to our patients," says Weeks. "There’s a dilemma that we face as doctors who are taking patients and also putting them on clinical trials," adds Weeks. "With the doctor hat on, you want to do your very best for the patient in front of you. However, with the researcher hat on, you want to generate knowledge that will help the next generation of patients."
Reference
1. Joffe S, Cook E, Cleary P, et al. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 2001; 358:1,772-1,777.
Medical colleges plan to stop research fraud
Medical royal colleges in the United Kingdom are asking for a new oversight body to be established to stamp out fraud and misconduct in biomedical research studies. Researchers are calling for the creation of a government-funded National Panel for Research Integrity to prevent and investigate research misconduct, according to the journal Proceedings of the Royal College of Physicians of Edinburgh.
Such an organization would bring the UK in line with other countries, such as the United States and Denmark, where oversight is a little more stringent. Currently, the General Medical Council in the UK investigates suspected cases of deliberate misconduct by physicians, but not others involved in biomedical science. Researchers warned that nonintentional misconduct by researchers almost certainly causes more harm to patients than deliberate deception and also needs to be tackled.
"The medical royal colleges have developed debate around this subject, and this blueprint is the first stage in developing a model for a system that would allow health professionals and the public alike to have full confidence in the quality and standard of biomedical research in the UK," says professor Gordon Lowe of the Royal College of Physicians of Edinburgh.
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