Washington, D.C. (August 2, 2010) — The Pharmaceutical Research and Manufacturers of America (PhRMA) issued the following statement today regarding efforts to enhance transparency:
“PhRMA and its member companies have a longstanding commitment to the ethical conduct of clinical trials and to increasing transparency by reporting more information about clinical trials.
“We are always looking for ways to enhance our voluntary industry codes and, to this end, supported a joint position statement in June with the International Federation of Pharmaceutical Manufacturers & Associations to enhance publication of clinical research. The joint statement calls for publication of summaries of all Phase III clinical trials and all clinical trials of significant medical importance in peer-reviewed journals.
“PhRMA’s commitment to enhanced transparency of clinical research is in addition to our member companies’ unanimous support of PhRMA’s recently revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which call for registration and online publication of summaries of all clinical trials in patients for approved medicines. What’s more, PhRMA’s Clinical Trial Principles also call for our member companies to disclose summaries of all clinical trials in patients for investigational medicines whose development programs have been discontinued.
“It is our hope that the additional transparency of PhRMA’s member companies will benefit patients and healthcare professionals. PhRMA has also supported continued development of the federal clinical trial database, ClinicalTrials.gov.
“The study, published today by the ‘Annals of Internal Medicine,’ demonstrates one more way that patients and the public health can benefit from increased transparency: The study would not have been possible without the large volume of information about ongoing and completed industry-sponsored clinical trials provided through ClinicalTrials.gov and supported by PhRMA and its member companies.
“While our review of the study continues, it is important to note that the authors acknowledge that industry-funded trials tended to be for later stages in the lengthy drug development process. As the authors note, ‘Later-phase trials may be more likely to have positive outcomes, because there is more certainty about the drug’s efficacy and safety at this advanced stage in the drug-development cycle.’
“Developing a new medicine is costly, time-consuming and the odds of success are quite low. At the earliest stage of discovery, researchers closely analyze up to 10,000 compounds of interest. By the time clinical tests occur in humans, more than 10 years later, promising therapies have been winnowed from the thousands to single digits.
“PhRMA companies lead the world in the search for new cures. Our member companies invested an estimated $45.8 billion in 2009 alone to discover and to develop new medicines.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.
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