"Biggest challenge in running a chronic Hepatitis B trial is often patient recruitment"

Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics, has released its latest disease report: Hepatitis B - Global Clinical Trial Landscape (2025) in March 2025.

- Ankit Kankar

The report highlights a 31.95 per cent CAGR in Hepatitis B trials from 2020 to 2024, driven by advances in small molecules, siRNA therapies, and therapeutic vaccines. To know more about the clinical trials landscape of Hepatitis B, particularly the Asia Pacific region, BioSpectrum Asia interacted with Tom Hickey, Director-Therapeutic Strategy at Novotech. Edited excerpts;

With over 25 years of experience and more than 90 Hepatitis B clinical projects completed, Novotech remains at the frontline of advancing innovative therapies. What key lessons has Novotech learnt from conducting these projects?

From decades of experience in Hepatitis B clinical trials, Novotech has identified key success factors namelySite & Patient Selection Drives Success:

Knowing the right patients for your study, and where to find them. Having a balance of high recruiters with the global Key Opinion Leaders that will guide the trial progress. Regulatory Planning Is Critical: Early engagement with regulatory agencies reduces approval delays and ensures trial designs align with evolving guidelines. Regulators in many of the key regions for chronic Hepatitis B (CHB) are very open to engagement and scientific merit, with many innovations in both therapy class and trial design being first used in this space.

Adaptability to New Science Is Essential:

With the rapid emergence of new or improved assays and biomarkers Novotech remains agile and committed to integrating new therapeutic advancements into trial protocols. Retention Strategies Ensure Long-Term Study Viability: Patient adherence is crucial, given the extended duration of many Hepatitis B trials, while it’s important to recruit patients quickly it is futile if they don’t remain on the trial. Novotech employs digital engagement tools and patient support programmes to improve retention rates.