Research integrity in clinical trials: innocent errors and spin versus scientific misconduct

Purpose of review High-quality research underpins the best healthcare practice. This article focuses on analyzing the current literature to promote research integrity across clinical trials. Recent findings Recent admissions of questionable practices by researchers have undermined practitioner and public confidence. There is limited evidence specifically for ethical and professional standards in clinical trials to guide researchers and institutions to embed integrity into research practice. Unintentional errors and spin in research are not uncommon as training in design and conduct of clinical trials is not part of health education for medical and allied health professions. There is unfamiliarity with procedures, such as prospective registration, a priori documentation of statistical analysis plans, openness in data sharing, and so forth. This, combined with the academic culture of secrecy, has led to an environment where scientific suspicion, instead of trust, is the norm. Existing science integrity documents are devoid of specific recommendations about how to translate any guidance into clinical trial practice. There is a need for constructive, supportive and multidisciplinary approaches based on open dialogue and continuous training, targeting the research environment. Research integrity now needs to take centre stage to re-instill confidence in randomized trial evidence to inform clinical practice.

Automated summary

This article analyzes the current literature to promote research integrity in clinical trials. Recent admissions of questionable practices by researchers have undermined confidence. There is a lack of specific recommendations for ethical and professional standards in clinical trials, and a need for constructive, supportive, and multidisciplinary approaches to embed integrity into research practice.