Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

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.

Impact of the COVID-19 pandemic on clinical trials with drugs

“…Even the first draft of the EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic recommended: "The feasibility to start a new clinical trial or include new trial participants in an ongoing trial should be critically assessed and initiation of new trials is generally not expected unless these are trials aiming at testing new treatments for COVID-19. "(E-mail of the European Commission of 19 March 2020, unreferenced) Certainly, many drug authorities are understaffed [3] and applications for COVID-19 trials were still approved rather fast without using the full time span permitted by the drug law. In addition, assessors of drug authorities often had to work from home, frequently with limited IT-resources, restrictions to access all documents needed and little communication with colleagues.…”

Clinical trials challenges - impact of the new clinical trial regulation on the conduct of clinical trials

“…The new Regulation is expected to reduce the number of redundant trials, if applied adequately 17,18 . Redundant trials are those trials that investigate issues that may be 'answered satisfactorily with existing evidence' 19 .…”

“…Such trials are considered 'unnecessary duplication of research efforts' 20,21 and pose an ethical problem as they unjustifiably lead to exposing subjects to risks. For example, increased transparency, as one of the main pillars of the new Regulation, is one of the instruments for reducing wasteful research because it will disable this type of research that occurs as a result of lack of transparency 17 . In addition, increasing the availability of data can support academic research, strengthen the integrity of the clinical trial system, and increase public trust in this system 15,22 .…”

Barriers and Facilitating Factors for Conducting Systematic Evidence Assessments in Academic Clinical Trials

“…Ethics committees have also been called on to more vigorously advocate for an evidence-based approach. 45 …”