Randomised controlled trials (RCTs) are considered the gold standard for studying the safety and efficacy of new interventions and are generally required by regulatory bodies for approval of new therapies. RCTs reduce bias by controlling both known and unknown confounding factors through random assignment of participants to the intervention under investigation or the control. The results of an RCT are only as good as the design of the trial itself, with inadequately designed studies resulting in unreliable results. A systematic review of 1,147 RCTs examining the consequences of poor reporting showed trials with inadequate or unclearly reported allocation concealment exaggerated the estimates of the intervention’s effectiveness by an average of 25%.1 The CONSORT (Consolidated Standards of Reporting Trials) Statement (simply known as CONSORT) was developed in 1996 in response in an effort to improve reporting of clinical studies and reduce wastage of precious research resources.
The CONSORT statement was developed by a group of clinical triallists, statisticians, epidemiologists and biomedical editors and has been endorsed by countless medical journals and editorial groups including the International Committee of Medical Journal Editors. CONSORT is a living, evidence-based guide, originally consisting of a 22-item checklist and a four-point flow diagram. CONSORT has been revised in 2001 and most recently in 2010 to address emerging trends and further clarify previous versions, resulting in additions to the checklist and flow diagram. Multiple extensions of CONSORT have also been developed to encompass the diversity of study designs and phases such as cluster trials, pilot and feasibility trials and even herbal interventions.
The CONSORT statement addresses every step in the study process from calculating sample size, recruiting and randomising participants appropriately, to analysing and publishing data. It is strongly advised that anyone who is involved in clinical research whether it be sponsors, principal investigators, study coordinators, editors and contract research organisations refer to the standards when developing protocols, running studies and publishing data to ensure accurate and verifiable reporting of study outcomes that can progress medicine.
- Keech.A, Gebski.V and Pike.R, (2007). Interpreting and Reporting Clinical Trials. (Australasian Medical Publishing Company)