A Q&A on PhRMA's Principles of Conduct for Clinical Trials and Communication of Clinical Trial Results

Why are you publishing these principles now? 

Although pharmaceutical companies have long followed ethical principles for conducting clinical trials – in addition to FDA regulations and standards published by the International Conference on Harmonization and other international bodies – these principles have never been set down by the Pharmaceutical Research and Manufacturers of America (PhRMA) in one place before.  In addition, criticisms of clinical trials – not necessarily trials conducted by the pharmaceutical industry – have been published in the media (often in sensationalized fashion) and these criticisms needed to be addressed so confidence can be restored in the clinical trial process.  To that end, some higher standards were incorporated into these principles.

What’s new in these principles?

The principles spell out long-established practices for conducting clinical trials. They also raise the bar by reducing the possibility of conflicts of interest on the part of researchers conducting the trials, and they make more information available on the results of a trial, whether these results are favorable to the company sponsoring the trial or not.  

Are all researchers, including academic researchers, bound by these principles?

The principles are voluntary.  Pharmaceutical and biotechnology companies that are members of PhRMA drew up the principles and agree that the principles are important for the quality of research and the protection of research participants.  We hope that other researchers, including academic researchers, will join us in abiding by these principles.  We expect that the principles will be enforced by public opinion.

What are the benefits of clinical trials?  What are the risks? 

Without clinical research studies, no new medicines would be made available to patients.  The primary goal of a trial is to generate new knowledge about a potential medicine so that regulatory authorities can determine whether the medicine is safe and effective.  People who participate in clinical trials have the satisfaction of knowing that they are helping to advance the frontiers of medical knowledge.  Often, the participants themselves benefit from the medicine being tested and/or the care received while participating in the clinical trial.  But the primary purpose of clinical trials is to advance the knowledge of researchers and regulators so that new  treatments and cures can be developed.

The medicines tested in clinical trials have already undergone rigorous safety testing in both the laboratory and animals, but people who participate in clinical trials are, in a sense, pioneers.  That’s why they have to understand and sign informed consent agreements.  The trials are monitored by health care professionals including both company employees and non-company employees, regulatory authorities, and the hospital where the trials are conducted. 

Do these principles apply all over the world – including in developing countries?

Yes, the principles apply all over the world.  The number of new medicines in development is increasing, and so is the average number of clinical trials required for each potential new medicine.  So more and more clinical trials are being conducted each year.  The overwhelming number of these trials are conducted in the United States and other developed countries.  But, in recent years, companies have increased testing in developing countries.  Also, companies are developing an increasing number of medicines for diseases that have a higher prevalence in developing countries and must be tested in the countries where the disease exists. 

Trials are conducted in accordance with applicable laws and regulations, as well as locally recognized good clinical practice.  Companies that wish to use the clinical trial results to have a medicine approved in the United States, Europe or Japan must comply with standards published by international organizations such as the International Conference on Harmonization (ICH). 

What is the effective date for these principles?

The principles, many of which reflect existing practices by the industry, become effective for trials begun after October 1, 2002.

Where can people find information about participating in clinical trials?

There are a number of websites that list information about clinical trials.  Following are three places from government and industry that can provide people with important information:

http://www.clinicaltrials.gov/ct/gui/c/a2b/info/resources - National Library of Medicine's Introduction to Clinical Trials

http://www.nci.nih.gov/clinical_trials/ - National Cancer Institute Cancer Trials Support Unit

http://www.centerwatch.com - CenterWatch Clinical Trials Listing Service