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Table 1 Major barriers to the conduct of randomised clinical trials

From: Barriers to the conduct of randomised clinical trials within all disease areas

Duley and co-workers’ five major barriers to RCTs [5] Comments ECRIN’s eight major barriers to RCTs Comments
Inadequate funding Still highly relevant, but if a very substantial proportion of clinical research is considered wasted, it might not be the most prominent problem Inadequate identification of the clinical research questions Can only be based on systematic reviews of the literature. Added as a new barrier
Overly complex regulations producing needlessly complex trial procedures Still highly relevant Inadequate knowledge and understanding of clinical research Too often results from observational studies are used as evidence for interventions where randomised clinical trials ought to have been conducted
Excessive monitoring Still highly relevant Inadequate knowledge and understanding of clinical trials Too often when the randomised clinical trial design is chosen, it is not properly designed and conducted
Over-restrictive interpretation of privacy laws without evidence of subject benefit Still highly relevant Inadequate funding Funding could be used more effectively by teaching investigators how to properly use the clinical research designs available
Inadequate understanding of methodology Still highly relevant - the major problems have now been highlighted and brought to the forefront Inadequate infrastructures Added as a new barrier
   Overly complex regulation There is a need to harmonise regulations of clinical trials on all interventions globally
   Excessive, non-focused monitoring Should be assisted more through central monitoring in the future
   Too restrictive privacy and lack of transparency Still highly relevant
Lack of transparency added as new barrier
  1. Major barriers as identified by Duley and co-workers in 2008 [5], and by the present European Clinical Research Infrastructures Network (ECRIN) panel in 2017. RCT randomised clinical trial