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Equipoise in Neurosurgical Trials: Ethical Considerations and Challenges for Trial Conduct
Ranjit D Singh1, Jeroen T J M van Dijck1, Hugo F den Boogert1
1Department of Neurosurgery, University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Leiden and The Hague, The Netherlands.
Abstract:
The notorious Queen vs Dudley and Stephens case highlights the persistent potential conflict between safeguarding individual rights and serving the collective good, a dilemma that also arises in clinical research. Doctors face the challenge of providing the best possible care for each patient while contributing to medical progress through randomized clinical trials. A key concept is equipoise: Fried emphasized personal uncertainty, whereas Freedman proposed clinical equipoise, grounded in professional disagreement among experts. In neurosurgery, strong personal preferences, time-sensitive decisions, and limited evidence deepen these challenges, often reducing trial participation. The clinical judgment principle offers a potential solution by combining community-based and individual perspectives, allowing patient enrollment when both treatments are considered medically reasonable. This balanced approach supports ethical neurosurgical trials while promoting scientific advancement and protecting patient interests.
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