New UK Clinical Trial Regulations - Missed RWD Opportunity

Latest Updates About New UK Clinical Trials Legislation and Impact on Real?World Research Studies

The Medicines & Healthcare products Regulatory Agency (MHRA) have published the outcome of the 2022 public consultation on proposed changes to the UK’s clinical trials legislation [Link].

The MHRA have confirmed that the notification scheme for low intervention clinical trials, such as pragmatic clinical trials, will be included as a legislated path in the new regulations, where previously it was only guidance.

MISSED RWD OPPORTUNITY - The MHRA had proposed that trial participant data could continue to be collected in a non-interventional study after the trial had ended and before the investigational drug had received marketing authorisation.?Unfortunately, this proposal has not been taken forward.?Drug manufacturers will need to rely on the existing early access to medicines scheme, which is limited to the treatment of “life threatening or seriously debilitating conditions when there is a clear unmet medical need.”

EU - EU Regulators Publish Discussion Paper on Data Analytics Roadmap [Link]

EU - EU-US Data Shield Replacement Closer to Adoption [Link]

UK - NICE Says Evidence Laking that COVID-19 Treatment Evusheld is Effective in Protecting Vulnerable Adults Against Current Variants [Link]

USA - New Draft FDA Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers - Confirms 21 CFR 11 Requirements for RWD Studies [Link].

USA - New FDA Rare Neurodegenerative Disease Grant Program - The FDA have announced a new funding opportunity for the FDA Rare Neurodegenerative Disease Grant Program to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults [Link].?

NIS Essentials - Introduction to the CDISC Study Master File for NIS [Link]

13 April 2023 - USA - Reagan-Udall Foundation for the FDA - Real-World Evidence Series - Public Webinar on the Latest? FDA-Issued Draft Guidance on Externally Controlled Trials [Register Here]

Real World Research (RWR) refers to the collection of patient-related data in a real-world environment (real-world data) and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through analysis [Link].

ABOUT STUART MCCULLY...

Stuart is a real world research (RWR) industry expert and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.

Stuart regularly provides RWR regulatory science advice, guidance and training to top 10 Pharma, Biotech, Medical Device companies and CROs.