Principles on Clinical Trials

The development of new therapies to treat disease and improve quality of life is a long and complex process. A critical part of that process is clinical research, the study of a pharmaceutical product in humans.

Clinical research involves both potential benefits and risks to the participants and to society at large. Investigational clinical research is conducted to answer specific questions, and some aspects of the therapeutic profile of the product(s) tested my not be fully known without study in humans.

In sponsoring and conducting clinical research, PhRMA members place great importance on respecting and protecting the safety of research participants. Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization. The principles of these and similar reference standards are translated into legal requirements through laws and regulations enforced by national authorities such as the U.S. Food and Drug Administration.

PhRMA members have always been committed, and remain committed, to sponsoring clinical research that fully complies with all legal and regulatory requirements. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulator agecies; 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 (IRBs/ECs).

PhRMA adopts these voluntary principles to clarify our members' relationship with other individuals and entities involved in the clinical research process and to set forth the principles we follow.

Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (PDF)

Updated Principles for Conduct of Clinical Trials (Press Release)

Questions & Answers on Principles of Conduct for Clinical Trials (Fact Sheet)

In related news, learn more about Principles for Disclosing Information about Clinical Trials.