Publication of clinical trial results: Time to wake‑up

Abstract

Scientific publications are important by‑product of clinical trials and play a key role in the advancement of medical practice and research. Besides disseminating the efficacy and safety information for new drugs and indications, publications also bring forward the newer trends and techniques, and the drawbacks and limitations of clinical trials. This knowledge is indispensable and contributes to focused growth of clinical research. Importantly, the published data form the base of medical practice and decisions and hence important for physicians, patients, and healthcare payers. Nonetheless, it is a tribute to patients who participated in the trial so that several other patients like them can avail the benefit of the treatment if a drug is safe and efficacious. However, if the data from clinical trials are not adequately published, it thus prohibits the physicians, patients, and researchers from getting the desired benefit. Even the published data are incomplete and biased at times when compared to the study protocols, especially when results are unfavorable or negative. Despite the mandates from regulatory authorities, recommendations, and guidelines, the adherence to publication of clinical trial data remains partial and biased. Thus, this review describes the need for publishing clinical trial data, the challenges, and solutions in light of recommendations and threats.