REGULATORY PUBLIC DISCLOSURE (RPD) - May 2022
Medicines and Vaccines
EMA Guidance and News
EMA have released ‘Key performance indicators (KPIs) to monitor the European clinical trials environment’ that includes metrics on the CTR and CTD from 31 Jan to 30 Apr 2022.
European Health Data Space
The European Commission is proposing The European Health Data Space Regulation to set up a governance ecosystem for both primary and secondary use of health data. An open public consultation will ensue. This is one to keep an eye on, as it seems inevitable that it will impact clinical research data of the future.
FDA Guidance and News
- Final FDA Guidance ‘Bioavailability Studies Submitted in NDAs or INDs — General Considerations Guidance for Industry’ dated April 2022 is out now.
- The FDA’s CDER and CBER invite you to the virtual 2022 Regulatory Education for Industry Annual Conference. The event will take place from 6 June through 10 June 2022. Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. Registration and attendance are free. Register here.; agenda here.
Real-World Data
Reuters Events are hosting a free real-world data (RWD) Webinar to help understand the nuances of the rare disease landscape, and overcome factors limiting data capture, data abundance and data robustness. Experts from Pfizer, Novartis, Alexion Pharma, Cegedim Health Data and UCB will discuss how pharma can effectively utilize anonymized RWD for rare diseases. The 1-hour webinar is live on 24 May 2022 or you may watch on-demand afterwards.
Transparency and Disclosure Resources and News
- This TranspariMED article ‘Access to information on drug trials in Europe is getting worse, new report warns’ describes a Prescrire report that shows a decline in recent years in access to information held by EMA on clinical trial results. Download the report here.
- This TranspariMED article shows that ex-US institutions are at risk of FDA fines for unreported clinical trial results.
- Real Life Sciences (RLS) have released resources to support process development around the EU CTR and CTIS on their website including a full-length webinar and accompanying slides on the EU CTR, along with case studies, the CTIS training guide and links to other relevant materials.
Development Strategy News
- Fletcher et al’s publication, “Marking 2‑Years of New Thinking in Clinical Trials: The Estimand Journey” presents a good summary on estimands and explains how an estimand framework relates to clinical aspects of study design. The section 'Implementing the Estimand Framework in Protocols' is useful for CSP authors, and highlights some challenges. The article is a good reflection of the point the industry has reached with estimand, and it highlights that there is still some way to go.
- This National Academies of Sciences, Engineering and Medicine report highlights the persistent lack of diversity among participants in clinical trials as a critical issue that is harming both populations that have long been left out of pivotal medical studies and the entire biomedical research enterprise.