Solutions OP Clinical Trials UK

Our analysis on Eisai And Elly Lilly Alzheimer's Clinical Trials scandal. It involves 2 drugs -Leqembi, manufactured by Eisai and Kinsunla, manufactured by Eli Lilly. Both drugs are used to treat Alzheimer’s and they have known side effects of brain bleeding or swelling. It is also known that some patients have genetical predisposition to experience such brain injury. However, some patients died during the Eisai study and many had brain injury adverse events with different severity. There is a discussion on what could have been done to handle the situation better.

This episode of the podcast is providing an overview of METRIC Framework and practical advice on assessing the quality of medical data which is used to train AI. It covers common issues with medical data quality and how these could be tackled.

This episode is dedicated to clinical trials diversity plans. It discusses what are the current regulations in the USA and Europe, why do we need diversity plans and some recommendations how to improve diversity in clinical trials.

Sometimes clinical trials go wrong for various reasons and they need a study rescue. The study rescue requires experienced team who can step in and help bring back the clinical trial to compliance. In this episode you can learn what are the common issues with the clinical trials that end up needing rescue and some practical advices on how to avoid these issues.

The latest episode is about digital therapeutics and what can we expect from them in the future. There is also a discussion on the latest report from MHRA on mental health digital therapeutics and the feedback from users and specialists.

This episode is an analysis of the changing genomic data regulations and some upcoming biosecurity regulations and how they could affect clinical research. It covers the following regions: China, USA, UK and the EU.

This episode is dedicated to the budget and contract process for clinical trials in the UK. The main topic is what is the current process, what works and what doesn't and how we can improve it.

Can a clinical trial fail because of poor protocol design? You can learn the answer in this episode which reviews a real life case of a clinical trial which failed because of its protocol design.

This episode is about patients' involvement in clinical trials and the challenges and benefits for the industry of involving patients in the study design and review of patient facing materials. While it is easy to engage patients in academic and social research, there are some unique challenges for pharma and biotech companies.

This episode is about the Research Ethics Committees in Europe and some of the challenges that they will face in the future. It also covers some of the existing challenges that everyone in the biotech and drug development industry faces when dealing with Ethics Committees. At the end, as always, there will be some recommendations how to improve the current practices and address the challenges.