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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