GUEST COLUMNISTS

• Survey Reveals High Levels Of CTIS Adoption In Europe

  Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

• India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022

  To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

• Key Learnings To Optimize Clinical Trials During COVID-19

  Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes. 

• Key Insights From The 2022 PDA/FDA Joint Regulatory Conference

  Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

• How To Implement Patient-Focused COAs

  Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

• How To Optimize Returns On Plain Language Summaries

  The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

• RWE & Advanced Diagnostics Propel Better Patient Outcomes

  Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.

• FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics

  The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.