1. WHAT IS A RCT
In clinical research RCTs or randomized clinical trials are experimental studies that are used to answer clinical practice questions, and in the development of new medical interventions they form the basis for regulatory authorities’ decisions on their approval. RCTs are considered the gold standard in scientific research as they can prove the superiority of a new treatment over an existing one. As a result, they can guide progress in medicine and clinical practice.
In RCTs, subjects are randomly assigned either to the group receiving the treatment under investigation or to a group receiving standard treatment (control). Subjects who are randomized have a similar degree of variance attributable to measured and unmeasured factors that are then statistically compared in their relative exposure to an intervention.
Health-related interventions are those used to modify a biomedical or health-related outcome, such as clinical trials that involve drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.
All RCTs require a protocol describing the rationale, methods, proposed analysis plan, and organizational/administrative details from trial inception to the reporting of results.
2. WHY REGULATIONS ARE NEEDED
The result reliability of a randomized trial depends on the extent to which potential sources of bias have been avoided. To avoid the negative effect produced by bias, regulations appeared to set some guide on how bias should be avoided.
If there were no regulations bias could mask the true effect of any health intervention. The rationale for implementing regulations is to anticipate, detect and control bias.
As a result of reviewing the literature, inconsistencies were found when analyzing the ways in which RCTs were performed. In response to concerns about the quality of randomized clinical trials in the mid 1990s, a new set of recommendations was created. The CONSORT statement, when correctly applied, allows for the identification of the validity of RCT results.
The CONSORT guidelines specify details that should be explained in every RCT submitted for publication in many medical journals. It is based on a 25 checklist which is based on different sections such as:
Title and Abstract: The title should specify that it is a RCT and the abstract must provide a summary of the trail design, methods, results and conclusions.
Introduction: The background and the explanation of the rationale. The Objectives of the study should be included in this part.
Methods: In this section is where the trial design is explained as it includes the criteria used to select the patients. Interventions should be explained in a manner that allows for replication. Primary and secondary outcome and the sample size are also explained in this part. Randomization (explaining sequence generation, allocation and implementation), blinding and statistical methods complete the methods section.
Results: This includes participant flow, how the recruitment was done, which was the baseline data and the figures analyzed. In this part, the outcomes and estimates for each primary and secondary outcome should be included. Other analyses (such as those performed in subgroup analyses or adjusted ones) should be presented in ancillary analyses. Harm or unintended effects for each group are also included in this part.
Discussion: This is based on the limitations, generalizability and interpretation of the results
Other information: The registration number of the trial, the full protocol available and the funding, explaining the sources and the role of the funders.
ICMJE (International Committee of Medical Journal Editors) The International Committee of Medical Journal Editors is a small group of general medical journal editors working together to improve the quality of medical science and its reporting to increase the quality of randomized clinical trials.. ICMJE endorses WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov registries as they meet several criteria.
– They are accessible to the public at no charge
– They are open to all prospective registrants
– They are managed by a non-for-profit organization
– They have a mechanism to ensure the validity of registration date
– They are electronically searchable
To be considered adequate, all clinical trials must also include the minimum 24-item trial registration dataset before the enrollment of the first participant.
But what are the reasons to register trials?
The first reason is that trial registration helps alleviate publication bias, as all clinical trials, both with positive and negative results, would be accessible to researchers to make systematic reviews.
The second reason is that trial registration provides a record of a trial’s primary outcome and by doing this it is believed that the temptation of switching endpoints or introducing new ones is reduced. It also enables peer reviews that make it possible to identify selective or misleading reporting to improve the quality of scientific research.
The third reason is that by doing this collaboration and communication among researchers are improved. It allows researchers to avoid duplication of research but also identify which new studies are needed.
Finally, it informs the public about current research and allows patients who might be eligible to know the enrollment procedure for those trials.
5. TAKE HOME MESSAGES
· If correctly performed, Randomized clinical trials (RCTs) are the most reliable form of scientific research, and, when combined in systematic reviews, evidence-based guidelines can be obtained.
· Randomized clinical trials, as other clinical studies are susceptible to be influenced by bias so to increase its quality regulations are needed.
· The CONSORT guidelines compromise a 25-item checklist that allows authors to prepare the way in which trial findings are expounded, allowing for full and transparent reporting, reducing bias influence and problems arising from inadequate reporting of RCTs.
· Registration also increases the validity and quality of RCTs. It reduces duplication of research and changes in endpoints, increases communication between medical communities, and provides transparency regarding RCTs that are currently being carried out.