News Headline: Mesothelioma Patients to Benefit as Pfizer Leads the Way With Clinical Trial Transparency
Outlet Full Name: Mesothelioma Help
Author: Nancy Meredith
Pfizer, one of the world’s largest drug makers, has announced that it will focus on transparency during its research and development efforts. The company will offer broader access to information from its clinical trials, even allowing study participants access to the data. This new approach allows researchers current information for help in guiding the industry in the latest mesothelioma and cancer research breakthroughs.
The new company policy, according to a press release issued December 4, meets or exceeds the “Principles for Responsible Data Sharing” issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013.
“Access to clinical data empowers today’s patients with information and resources to better manage their health and wellness,” said Craig Lipset, head of Clinical Innovation for Pfizer Worldwide Research and Development, when announcing Pfizer’s new policy.
According to the National Institutes of Health, clinical trials are at the heart of all medical advances. Clinical trials serve to uncover better ways to treat, prevent, diagnose and understand human disease. They provide mesothelioma researchers with critical information needed to allow them to move their findings from the lab to patients. They also offer patients access to a treatment that might not otherwise be available.
Pfizer’s updated information policy includes:
Publishing synopses of clinical study reports filed with regulatory agencies for approved products for which basic results are posted in the clinicaltrials.gov registry (dating back to September 2007). These synopses will include summary results for all primary and secondary endpoints; any data that could be used to identify individual patients will be removed.
Producing and distributing lay-language summaries of clinical trial results to trial participants who wish to receive them, starting with trials that begin enrolling in 2014, in countries where regulations permit.
Piloting the use of “Blue Button™” technology (launched by the U.S. Departments of Veterans Affairs and Health and Human Services) to enable Pfizer trial participants to download their own electronic clinical data collected in the trial.
Pfizer has at least two drugs in its pipeline that could benefit mesothelioma patients: dacomitinib, a phase 3 EGFR inhibitor for non-small cell lung cancer; and tanezumab, a phase 2 cancer pain treatment.
Pfizer’s Xalkori, an ALK-inhibitor drug for lung cancer that received FDA approval in November, is significant not only for the survival rate, but for the fact that the drug is tailored to patients with a specific genetic marker – ALK in this case. Just as with many cancers, lung cancer and mesothelioma treatments can differ dramatically across patients, but focusing on personalized treatment targeted to a patient’s unique characteristics optimizes the potential for success of the treatment.
Pfizer believes that each year close to 10,000 of the 220,000 diagnosed with lung cancer, and potentially mesothelioma patients, could benefit from the treatment of Xalkori.