Randomized controlled trials (RCT) are the definitive method for determining primary
treatment efficacy and a crucial step in the development of novel therapies. Patients
may participate in such trials for altruistic reasons [
1
,
2
], but probably also in hope for additional benefit [
[2]
]. An enhanced sense of care beyond the classic physician — patient relationship and
more rigorous adherence to ‘best practice’ standards and international guidelines
may be a major incentive for these patients. Yet, when being consulted as to whether
to participate in such a trial or not, many primary care physicians recommend to refrain
from participating. It is most likely that patients and clinicians alike, in the process
of making the decision, do not take into consideration the possible benefit from participation
alone, independent of the actual study outcome or the trial arm allocation.Keywords
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References
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- Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study.BMJ. 1999; 318: 1114-1117
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- Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials.Cancer. 1985; 56: 1710-1718
- Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review.Lancet. 2004; 363: 263-270
- Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials.Br J Cancer. 2009; 100: 1037-1042
- Characteristics and mortality outcomes of thrombolysis trial participants and nonparticipants: a population-based comparison.J Am Coll Cardiol. 1996; 27: 1335-1342
- Intensive lipid lowering with atorvastatin in coronary disease.N Engl J Med. 2005; 353 ([author reply −6]): 93-96
Article info
Publication history
Published online: September 03, 2016
Accepted:
August 26,
2016
Received:
August 24,
2016
Footnotes
☆This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
Identification
Copyright
© 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
