DIA: Driving Insights to Action

HHS Final Rule: Good Data Shared Well Leads to Great Science

The Department of Health & Human Services’ Final Rule on Clinical Trials Registration and Results Information Submission, issued in September 2016, will profoundly impact the conduct of clinical research in the US. Dr. Marla Jo Brickman (Senior Director for Clinical Data Transparency, and Compassionate Access Lead, Pfizer) serves on the program committee for DIA's Clinical Trial Disclosure and Data Transparency Conference and explains in this Global Forum podcast how this conference will help those working to implement this Rule. “We’re now getting to the point, not only at my company but at other companies, where we’re sharing data, researchers are getting their presentations and their manuscripts, and the benefits of the data sharing are becoming more prevalent and obvious,” says Dr. Brickman. “That’s what’s exciting: When this started, people didn’t know what to make of it. Now we’re seeing the fruits of the past couple years, where we’re really getting some good science as a result of this data sharing initiative.”

Patient Partners: Power That Rests in Us All

We see and hear many different terms, such as patient-centricity and patient engagement, in current conversations about incorporating the patient perspective in health care product development. Do they all mean the same thing? What’s the difference? “These are new partners in research. Patient-centricity, patient engagement, patient partnerships, patient-powered, patient-led, patient-driven, and patient preferences – a wealth of terms to describe this new relationship with individuals who are going to help the product developers of tomorrow understand: What is clinically meaningful? What are outcomes that matter?” explains Debra Lappin, Head of the Health Biosciences Practice for FaegreBD Consulting, in this Global Forum podcast. “I think ‘partnership’ is my favorite. A partnership recognizes that two parties come together, each with equal contributions to the end.” Learn more about these topics at DIA's Metrics for Patient-Centered Drug Development Conference.

Technology & Data Driving Europe’s ClinOps Forward

Clinical research and regulatory science professionals in Europe are currently dealing with implementing the Medical Device and In Vitro Diagnostic Regulations, the new clinical trial data transparency framework, big data, and framing how new artificial intelligence and other new tools can improve drug development. “We are very conservative as an industry, and obviously there’s always concerns about things like data protection, data integrity, and whatever we do with artificial intelligence has got to be within the bounds of data protection and data integrity guidelines,” explains Karen Roy, Senior Vice President, Client Solutions, for Phlexglobal, a provider of electronic Trial Master Files (TMFs). Ms. Roy co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files, and also serves on the program committee for DIA’s first Clinical and Regulatory Operational Excellence Forum in Europe.