Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges.

Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.

Conflict of interest.

The clinical research enterprise is increasingly scrutinized, in part because of the issue of conflict of interest. The issue is broad and its implications touch on a wide range of concerns, from the safety of patient care to the viability of a large industry. Numerous constituencies are affected by conflict of interest, and representatives of all of them convened in November 2002 for a one-and-a-half day discussion of the issues as well as possible solutions to both the perception and the actuality of such conflict. Participants included medical journal editors, news reporters, physician investigators, representatives of institutional conflict-of-interest oversight committees, representatives of the medical products industry, and Federal regulators. The resulting manuscript provides a review of the issues as well as desirable ways for each of the players to monitor themselves; each section thus contains provocative recommendations for eliminating conflict of interest to ensure that our vibrant health care system continues to foster exciting new advances to improve patient care.