RESEARCH TRIANGLE PARK, N.C. – October 13, 2010 – Technologies to capture and view clinical trial data in real time offer great potential to enhance patient safety, strengthen trial quality and accelerate drug development, but they also require new guidelines to ensure trial integrity, according to the white paper “Using Real-Time Data to Drive Better Decisions, Faster” released today by Quintiles, the world’s leading bio pharmaceutical services company.
Authored by Quintiles’ experts Paula Brown Stafford and Andrew Garrett, the paper identifies how drug developers can take advantage of real-time data throughout the course of a clinical trial, and recommends guidelines for granting access to blinded data based on professional role.
For drug developers interested in leveraging real-time data, the authors caution that it must be done in a planned, controlled and documented way to avoid risks associated with biasing a trial. With a data review protocol and a clear audit trail, drug developers can leverage real-time data to improve the conduct and outcomes of clinical trials, while following regulatory principles.
“In the New Health landscape, biopharma companies are under relentless pressure to accelerate drug development timelines while maintaining high quality standards and patient safety,” said co-author Stafford, President, Clinical Development, Quintiles. “Real-time data access can help drug developers proactively manage these requirements in ways that were difficult just a few years ago. At the same time, these real-time review capabilities require new guidelines to ensure the integrity of trial conduct from ethical and regulatory viewpoints.”
Electronic data capture and the advent of electronic data review tools makes possible ongoing review of data throughout the course of a clinical trial. If used appropriately, real-time data access opens the door for drug developers to streamline and improve clinical research. In the paper, Stafford and Garrett, Vice President, Global Biostatistics and Medical Writing, explore:
- Technologies that have made access to real-time clinical trial data more widely available.
- Regulatory implications of reviewing real-time data throughout the life of clinical trials.
- Clinical trial roles and the rationale for granting real-time data access.
- Guidelines and controls for the use of real-time data.
- The role real-time data play in enhancing patient safety, strengthening quality and accelerating clinical trial timelines.
- The tools that power real-time data capture and review.
Garrett said: “The notion of allowing drug developers open access to data during clinical trials is somewhat controversial, but we firmly believe that by applying appropriate controls the advantages far outweigh the dangers.”
Download the white paper at www.quintiles.com/perspectives.
About the Authors
Paula Brown Stafford is President, Clinical Development, Quintiles. Her responsibilities cover all of Quintiles’ Phase I-III services. Additionally, she is the Chair-Elect of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical study data. She also is a member of the Foundation Board of the School of Public Health at The University of North Carolina at Chapel Hill.
Andrew Garrett, Ph.D., is Vice President, Quintiles Global Biostatistics and Medical Writing. In addition, Garrett is Honorary Secretary and a Vice President of the Royal Statistical Society (RSS) with responsibility for Professional Affairs. He has held various committee posts with Statisticians in the Pharmaceutical Industry (PSI) and is referee for various journals including Statistics in Medicine, Pharmaceutical Statistics and RSS.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps bio pharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.