This podcast is dedicated to clinical trials and clinical research. We will be discussing different hot topics and analysis of the latest developments in clinical trials in pharmaceutical and medical devices industries. We have interviews with different industry experts.
New episodes will be available every 2 weeks.
This latest episode is an overview of the latest ICH GCP E6 (R3) changes and how they will affect clinical trials. This new guidance was released in Jan 2025 to provide further clarification on risk assessment and new technologies used in clinical research.
Our guest in this episode is the American entrepreneur, Charles Theuer, who has a long career in clinical research and drug development. He shares with us his analysis on the current trends and the future of oncology drug development. In this episode you can learn why there are less cancer clinical trials during the last years and what are the promising therapeutic classes. Charles has written 2 books which we also discuss in this episode. One of them, Unnecessary Expense, covers important topic...
Our guest in this episode of the podcast is Tommaso Prosdocimi, the Clinical Operations Manager of Iperboreal Pharma. Iperboreal Pharma is a small company developing new peritoneal dialysis products. We are discussing the necessity of having more treatment options of patients who need dialysis and also the unique challenges that small companies face in developing such products. Our conversation ends with some recommendations for regulators willing to support the development of dialysis products....
Our latest episode is conversation with our Senior Clinical Data Quality Manager, Lydia Ainsworth, in which we discuss clinical research as a career choice and we give advice to graduates who are interested to work in the field. We cover topics like how to gain experience in clinical research, what universities can do to increase awareness in clinical research as career, if you need degree in biology to work in clinical research, some CV creation tips and many others. You can read the transcript...
This episode provides overview of the new clinical trials regulations in the UK which was signed into a law in April 2025. It highlights the main changes of the regulations and provides some background information what triggered these changes.
This episode is dedicated to the benefits of self-managed clinical trials for pharma startups. It discusses some of the complex issues that startups face with fully outsourcing clinical trials to clinical research organisations. It also covers what could companies do instead of fully outsourcing clinical trials and how this could help them in a long run.
This episode discusses the challenges of patients involvement in clinical trials design and documents review. While patients' contribution to clinical research is often important is some cases it could be very limited. On the other hand there is a growing reliance from the regulatory agencies on patients' involvement to review informed consents which brings additional complications.
This episode covers the reasons for red tape in the pharma industry and how to improve the interactions between the pharma industry and the regulators. The answer to the question who is responsible for the increasing red tape in the drug development is not simple but both the regulators and the pharma industry have to admit their contribution.
In this episode you can learn about the unique challenges that startups and small pharma companies face and how the regulators can help new products to reach the market. While many regulatory agencies have members coming from big pharma companies their experience may not be sufficient to understand the drug development issues that small pharma companies have to deal with.
This episode has some key advices for pharma and biotech startups which are looking to set up their first clinical trial. It discusses budget, selecting the right vendors, regulatory strategy, protocol design and the risk assessment that startups need to do before they start.
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 d...
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.
The extended access scheme allows patients to have early access to drugs which are not approved on the market but have shown potential in clinical trials. In the UK for the last 10 years were treated over 1,200 patients while in the USA just in 2022 were treated 2,417 patients. Why is that difference? You can learn more from this episode and what could be done to improve access to medications to more patients in the UK.
This episode is dedicated to some of the main challenges that small pharma and biotech companies face. While funding is a critical one there are other issues like selecting the right consultants and vendors and optimising your clinical trials protocols in order to reduce your costs. There is a discussion on some options to optimise the cost of clinical trials.
In this episode are summarised some of the main data protection challenges in artificial intelligence shared during the conference from Information Commissioner's Office.
In this episode I will share some insights from BIVDA mid year meeting and discuss the issues the industry faces in bringing their diagnostic devices to the NHS. I will also suggest on how some of these could be tackled successfully.
This episode is dedicated to IDEAL Framework and how it could be used to support surgical innovations. The episode is a brief overview of IDEAL and its classifications.
This episode is dedicated to using placebo in surgical clinical trials; the ethical aspects and what needs to be considered when setting up such clinical trials. Special attention is given to ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines.
This episode is dedicated on real work evidence (RWE) and the benefits and challenges of using such data in research and in support of marketing authorisations. I am also discussing how to improve the quality of real world data when designing your clinical trial.
In this episode I will be talking about placebo clinical trials. I will discuss why we have placebo clinical trials; if they are ethical and what needs to be considered when designing such trials.
In this episode I will discuss the process of selection of physicians to be investigators in clinical trials and also the importance of this process. I will also discuss the overall involvement of physicians in clinical research and the main barriers for their participation.
In this episode I am discussing the recruitment challenges in clinical trials and how we can improve patients recruitment in clinical research.
