Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

Abstract

Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct. In this article, we present an overview of the reporting of RCTs in the biomedical literature with a focus on the three most common reporting problems: (i) lack of adherence to reporting guidelines, (ii) inconsistencies between trial protocols or registrations and full reports, and (iii) inconsistencies between abstracts and their corresponding full reports. Unsatisfactory levels of adherence to guidelines and frequent inconsistencies between protocols or registrations and full reports, and between abstracts and full reports, were consistently found in various biomedical research fields. A variety of factors were found to be associated with these reporting challenges. Improved reporting can build public trust and credibility of science, save resources, and enhance the ethical integrity of research. Therefore, joint efforts from the various sectors of the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers) are needed to reduce and reverse the current suboptimal state of RCT reporting in the literature.randomized controlled trial | reporting quality | transparency | guideline adherence | inconsistent reporting I n evidence-based medicine, evidence from well-designed randomized controlled trials (RCTs) is generally considered to be the gold standard to inform clinical practice and guide decisionmaking (1). However, several deficiencies in the reporting of RCTs have been frequently identified, including incomplete, selective, and biased or inconsistent reporting. For example, it was found that only about 60% of RCT reports provided adequate information on interventions (2). This suboptimal reporting of clinical trials may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct mainly due to the potential consequence of patients suffering and dying unnecessarily (3). Moreover, enhancing the quality and transparency of reporting is an ethical and scientific obligation in order to avoid wasting research resources, minimize risk of harms and maximize benefits of therapies, and enhance research integrity (4-6). Therefore, improving reporting of health research is an imperative that requires a variety of efforts by the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers). In this article, we highlight and provide some insights into the three most co...

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

“…Randomized controlled trials are the gold standard of studies to evaluate the efficacy and the safety of therapeutic interventions. Timely and accurate dissemination of clinical trial results is essential for investigators, policy makers, clinicians and, ultimately, for patients . It is also of paramount importance to ensuring public trust in the clinical research enterprise.…”

“…Timely and accurate dissemination of clinical trial results is essential for investigators, policy makers, clinicians and, ultimately, for patients. 1 It is also of paramount importance to ensuring public trust in the clinical research enterprise. Selective publication of clinical trials results introduces bias and has a detrimental impact on patient care and future research.…”

P-hacking in clinical trials and how incentives shape the distribution of results across phases

“…In addition to the public value of improving medical treatments, the information obtained through clinical trials is privately valuable for the sponsoring pharmaceutical companies that aim to demonstrate the safety and efficacy of newly developed drugsthe prerequisite for marketing approval by authorities such as the US Food and Drug Administration (FDA). Given the sizeable research and development costs involved (4) and the lure of large potential profits, investigators can suffer from conflicts of interest (5)(6)(7)(8)) and pressure to withhold or "beautify" unfavorable results (9,10) or even fabricate and falsify data (11).…”

P-hacking in clinical trials and how incentives shape the distribution of results across phases*

“…In addition to the public value of improving medical treatments, the information obtained through clinical trials is privately valuable for the sponsoring pharmaceutical companies that aim to demonstrate the safety and efficacy of newly developed drugs—the prerequisite for marketing approval by authorities such as the U.S. Food and Drug Administration (FDA). Given the sizeable research and development costs involved [4] and the lure of large potential profits, investigators can suffer from conflicts of interest [5–8] and pressure to withhold or “beautify” unfavorable results [9, 10] or even fabricate and falsify data [11].…”