In advance of implementation of EU Clinical Trial Regulation No. 536/2014 (Article 37.4), Pfizer has committed to providing a plain language summary (PLS) of clinical trial results understandable to research participants in these clinical studies. This PLS initiative will bridge a gap between the patient community and the pharma industry, and reinforce Pfizer’s responsibility to the patients and patients’ families who help advance the drug development process. These summaries are currently being posted to Pfizer’s clinical trial site, and will be accessible in the EU, via the EU Portal and Database, when those are available. Partnering with MMS will ensure consistency in the way that trial result summaries are written and will help to improve comprehension for the study participants, patients and others.
According to Peggy Zorn who heads up the Transparency group at MMS, “We are pleased to support Pfizer with their plain language summary needs given our experience and understanding of the Transparency space. MMS has been a pioneer in this field, supporting clinical trial disclosures with TrialAssure™ for the past decade, anonymizing patient level datasets for use by researchers as a part of ClinicalStudyDataRequest.com (CSDR) and was the first CRO to successfully complete preparation of regulatory document packages, including clinical trial reports, under the EMA Policy 0070 on publication of clinical data for medicinal products for human use. Our teams work seamlessly with Pfizer clinical and writing team members to ensure the highest quality of plain language summaries.”
“Pfizer is committed to ensuring clinical trial transparency requirements are met and that our study participants receive meaningful trial summaries. We are pleased to partner with MMS for the PLS initiative” said Dr. Sian Ratcliffe, Head of Medical Writing, at Pfizer.
About MMS Holdings Inc.
MMS is a global clinical research organization that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex regulatory submission challenges. As a data CRO, we are the pioneers and leaders in transparency services for our sponsors. Our strong industry experience and data-driven approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. For more information, please visit www.mmsholdings.com
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit www.pfizer.com