Abstract
The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.
Highlights
The problem of redundant trials When is a trial considered to be redundant? A universal definition of a ‘redundant trial’ hardly exists
randomised clinical trials (RCT) not meeting the criteria of having a clear hypothesis and demonstrating that an uncertainty around that hypothesis exists being established through a systematic review can be scientifically and ethically unjustified
In answering the question posed by the title, we have shown that the The European Union (EU) Clinical Trials Regulation clearly has a potential to effectively reduce redundant RCTs
Summary
The problem of wasteful – ie unregistered [1, 2] biased [3], unreported [4, 5], unpublished [6, 7], clinically irrelevant, inadequately designed, or otherwise wasteful [8,9,10,11,12,13,14,15,16,17,18,19] – trials has been debated relentlessly in the medical research community. A trial can be deemed to be wasteful if it does not produce new robust medical knowledge that can justify health risks borne by study participants, research efforts of investigators, and the allocated financial and other resources. This article focuses on the issue of redundant randomised clinical trials (RCT) – ie trials that do not contribute to the stock of biomedical knowledge relevant for clinical practice in a way that would justify the risks and costs involved. We describe the problem of redundancy in clinical trials, review the earlier discourse in the medical community and findings of empirical studies on this subject. Upon identifying key provisions under the EU Clinical Trials Regulation that are closely related to the justification of a trial against the background of prior research, we assess whether they can be leveraged to eliminate redundancy. We conclude by reinforcing the idea that, while the EU Clinical Trials Regulation strives to promote competitiveness of European clinical research, it is methodological quality and ethical integrity that shall be viewed as the core aspects
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