What is the event about?

Novel trial design has been highlighted as a priority for the government and the wider UK research community in the Life Sciences Sector 2 Deal.

The MHRA was specifically tasked with engaging with industry in order to be able to develop and further enable access to its advice services, as well as strengthen the UK environment for novel trials in the UK.

Previous work, such as the ECMC CID consensus paper, has noted challenges in conducting novel trials, and regulatory aspects were included in the recommendations.

The aim of this workshop is for MHRA to present examples of how Sponsors and researchers can improve the regulatory aspects of these trials, providing some initial solutions that can be taken forward. The workshop will also share the results from a survey on novel trials conducted by MHRA earlier in 2020 and lessons learnt from novel trial design for treating COVID-19.

The survey also asked stakeholders their opinions on the advice services available from MHRA and responses and further information will be included in Day 2 discussions.

After the workshop the presentations and any discussion aspects will be published in a workshop report.

Who the event is targeted at?

Delegates from across varying backgrounds will be able to register, including commercial and non-commercial, and it is hoped that learning points will be disseminated to colleagues following the workshop to help those not able to attend. Delegates do not need to have had any experience in novel trials, although this will be beneficial as basic knowledge will be assumed.

Pre-reading to understand the topic and context includes:

Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement. Available here: https://www.nature.com/articles/s41416-019-0653-9
Spread the word – clinical trial regulators do not bite! Blog article available here: https://medregs.blog.gov.uk/2019/03/15/spread-the-word-clinical-trial-regulators-dont-bite/
Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials. Available here: https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.1804

At the webinar participants will learn:

MHRA perspective on novel trials for all disciplines (non-clinical, quality and clinical) as well as the statistical challenges and considerations for a future marketing authorisation, and aspects to consider for GCP adherence
Examples seen by MHRA – pitfalls and how to avoid them when planning or executing novel design trials
Results of the survey and MHRA next steps
Available MHRA advice services

Agenda

Day 1 - Monday, 12 October 2020

13:00-13:10 Welcome, introduction and workshop outline day 1

Chair: Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, MHRA

13:10-13:40 Results of the survey - novel trials

Martin O'Kane, Unit Manager, Clinical Trials Unit , MHRA

13:40-14:00 Overview of MHRA experience - metrics and more

Lisa Campbell, Medical Assessor, Clinical Trials Unit, MHRA

14:00-14:20 Available guidelines and principles that MHRA accepts or adheres to

Beatrice Panico, Medical Assessor, Clinical Trials Unit, MHRA

14:20-14:30 Break

Discipline overviews and case studies - pitfalls and how to avoid them

14:30-15:00 Clinical aspects

Beatrice Panico, Medical Assessor, Clinical Trials Unit, MHRA

15:00-15:15 Quality aspects

Graham McNaughton, Pharmaceutical Assessor, Clinical Trials Unit, MHRA

15:15-15:30 Non-clinical aspects

David Jones, Non-Clinical Assessor, Clinical Trials Unit , MHRA

15:30-15:50 Statistical considerations on the planning of confirmatory trials

Khadija Rantell, Statistical Assessor, Licensing Division, MHRA

15:50-16:20 Q&A

Chair: Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, MHRA

16:20-16:30 Summary of Day 1 and introduction to Day 2

Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit , MHRA

Day 2 - Tuesday, 13 October 2020

13:00-13:10 Welcome, introduction and workshop outline Day 2

Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, MHRA

13:10-13:30 Integration of novel trial designs in the innovative licensing pathway

Dan O'Connor, Medical Assessor, Licensing Division, MHRA

13:30-14:00 GCP considerations for novel trials

Gail Francis, GCP Inspector, Inspections, Enforcement and Standards, MHRA

14:00-14:20 Lessons learnt from COVID-19 trials - novel design considerations

Juliet McColm, Medical Assessor, Clinical Trials Unit, MHRA

14:20-14:30 Break

MHRA advice meetings

14:30-14:45 Results of the survey - advice aspects

Martin O'Kane, Unit Manager, Clinical Trials Unit , MHRA

`14:45-14:55 Overview of what MHRA advice is available

Lisa Campbell, Medical Assessor, Clinical Trials Unit, MHRA

14:55-15:25 Case studies for how advice can help novel trials - clinical / quality / non-clinical

Alina Casian, Medical Assessor, Clinical Trials Unit, MHRA

15:25-15:45 Joint MHRA / NICE advice

Jeanette Kusel, Director for NICE Scientific Advice , NICE

15:45-1600 Innovation Office

Ian Rees, GMP Inspector, Inspections, Enforcement and Standards, MHRA

16:00-16:20 Q&A

Chair: Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, MHRA

16:20-16:30 Close - summary of Day 2 and workshop report information

Dr Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit , MHRA

Novel Trials Workshop