The proportion of randomized controlled trials that inform clinical practice

Abstract

Prior studies suggest that clinical trials are often hampered by problems in design, conduct and reporting that limit their uptake in clinical practice. We have described 'informativeness' as the ability of a trial to guide clinical, policy or research decisions. Little is known about the proportion of initiated trials that inform clinical practice. We created a cohort of randomized interventional clinical trials in three disease areas (ischemic heart disease, diabetes mellitus and lung cancer), that were initiated between 1 January 2009 and 31 December 2010 using ClinicalTrials.gov. We restricted inclusion to trials aimed at answering a clinical question related to the treatment or prevention of disease. Our primary outcome was the proportion of clinical trials fulfilling four conditions of informativeness: importance of the clinical question, trial design, feasibility, and reporting of results. Our study included 125 clinical trials. The proportion meeting four conditions for informativeness was 26.4% (95% CI 18.9 - 35.0). Sixty-seven percent of participants were enrolled in informative trials. The proportion of informative trials did not differ significantly between our three disease areas. Our results suggest that the majority of clinical trials designed to guide clinical practice possess features that may compromise their ability to do so. This highlights opportunities to improve the scientific vetting of clinical research.

Institutional dashboards on clinical trial transparency for University Medical Centers: A case study

“…Besides these updates, further transparency practices may be integrated into the dashboard in the future, e.g., dissemination of results as preprints, the use of self-archiving to broaden access to results [ 51 ], adherence to reporting guidelines [ 3 ], or data sharing [ 52 ]. Beyond transparency, other potential metrics could reflect the number of discontinued trials [ 53 ] or the proportion of trials that inform clinical practice [ 54 ]. The development of such metrics should acknowledge the availability of standards and infrastructure pertaining to the underlying practices [ 23 ] and differences between study types and disciplines [ 27 ].…”

<strong>A Maturity Model for the Scientific Review of Clinical Trial Designs and Their Informativeness </strong>

“…Table 14. Process Area 10, Reliability and quality 4 Terms included: Reliability Growth: "Reliability growth is defined as the positive improvement in a reliability metric or parameter of a product (e.g., a system) over a period of time due to changes in the product's design and/or the manufacturing process." [37] Quality Control: "While reliability is concerned with the performance of a product over its lifetime, quality control is concerned with performance of a product at a point in time."…”

“…2 dedicated scientific design review. This may account for the large difference in informativeness between industry and non-industry clinical trials (CT) found recently [4].…”

Open educational resources on how to conduct randomised clinical trials: a protocol for a landscape analysis

“…One study of 125 diabetes, ischaemic heart disease, and lung cancer trials reported that only 26% fulfilled the authors’ four criteria of informativeness (clinical question, design, feasibility, reporting). 10 Another similar study of 347 gynecology and obstetrics trials reported that only 10% fulfilled minimum half of the authors’ eight prespecified ‘usefulness’ criteria (clinical question, preceding systematic review, power, pragmatic, patient oriented, financially worth it, transparency). 11 One main reason for this lack of ‘informativeness’ may be that it is not a priority during medical, graduate, and postgraduate training to learn about proper conduct of clinical trials, and access to freely available quality educational material may also be sparse.…”