Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs frequently assert that drug makers missed or ignored safety signals present in those trials.
In reality, developing new therapies to treat disease and to improve quality of life is a long and complex process. And a critical part of that process is clinical research — without clinical research studies, no new medicines could be made available to patients.
Last week PhRMA issued revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results with a goal of helping assure that the clinical research conducted by pharmaceutical research and biotechnology companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.
Among the key changes in the updated Principles: Increased transparency about clinical trials for patients and healthcare professionals; enhanced standards for medical research authorship; and improved disclosure to better manage potential conflicts of interest in medical research.
PhRMA members have indeed had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. And actually, many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.
The key issues addressed are:
• Protecting Research Participants
• Conduct of Clinical Trials
• Ensuring Objectivity in Research
• Providing Information About Clinical Trials
Of particular note to my readers may be the document’s call for consistency with standards of the International Committee of Medical Journal Editors as journal guidelines for authorship; under these, anyone who: (1) provides substantial contributions into the conception or design of a study, or data acquisition, or data analysis and interpretation; and/or (2) writes or revises the manuscript involving important intellectual content; and/or (3) has final approval of the version to be published, should receive appropriate recognition as an author when the manuscript is published. Conversely, individuals who do not contribute in this manner do not warrant authorship. We have posted about this issue before.
As always, the guidelines are purely voluntary, and even member companies are free to adopt their own best practices and mold general guidance to their particular situations.