Andrew Freeman spent over two decades at GSK, where he led the company's efforts on clinical trial transparency - trial registration, results reporting, and sharing patient-level data with researchers. Yet when his own father was diagnosed with late-stage cancer, he couldn't find him a trial through clinicaltrials.gov. He gave up and found one through a personal contact instead. As Andrew puts it, that shouldn't be the way it works.

Andrew was at the WHO meeting in Geneva where the 20 or so data elements for study registration were identified, and since the end of 2022 he chairs the board of ISRCTN, the UK's clinical study registry.

In this episode, Andrew and Maya discuss:

• Why a "compliance mindset" and a "transparency mindset" are not the same thing - and why studies outside the regulatory definition of a clinical trial should still be transparent
• What the latest HRA metrics really show: 94% of UK studies registered sounds good, until you see that only around 44% published their results
• How ISRCTN is trying to make transparency easier - mandatory plain language summaries, mandatory recruitment site information, and a results posting system now in its second prototype
• Where AI could help make trial information understandable for patients, carers, and the public

Naomi Litchfield’s passion for Early Access Programs (EAPs) stems from a personal experience - her sister’s life was saved by an early access drug after being diagnosed with four rare cancers. With nearly 20 years of industry experience, Naomi is now the Director Patient Advocacy at Bionical Emas.

In this episode, Naomi and Maya discuss:
• What Early Access Programs are and how they work
• How EAPs provide hope and open doors for patients in need
• The challenges and considerations involved in setting up an EAP

Early Access Resources:
https://bionicalemas.com/resources/johnson-johnson-guide-to-expanded-access/
https://bionicalemas.com/resources/what-is-a-clinical-trial/
https://bionicalemas.com/resources/what-is-an-early-access-program/
https://bionicalemas.com/resources/what-is-real-world-data/

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Naomi Litchfield: https://www.linkedin.com/in/naomi-litchfield-499670122/

Clinical trials are evolving, but are we innovating fast enough? In this episode Maya sits down with Philip Raeth from Palleos Healthcare to explore how new trial designs can challenge the status quo. From adaptive methodologies to efficiency-driven models, we discuss how rethinking trial structure can help us tackle industry-wide hurdles—not just in patient recruitment and retention, but in trial execution, costs, and outcomes. What does the future of clinical trials look like? Tune in as we brainstorm new possibilities.

Follow Philip Raeth: https://www.linkedin.com/in/philip-raeth-51911114/
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/