The future of clinical trials: towards diversity and inclusion

Objectives of the meeting

Inclusion and diversity are urgently needed in all aspects of clinical trials, and more generally of any type of generated evidence, that is generalisable to and trusted by the populations who are most likely to benefit from the treatments being studied.

Fostering an inclusive environment that engages a diversity of patient participants, sites, staff, investigators and leader trialists is vital.

This CRT plenary meeting is dedicated to identifying actionable steps that should be taken or promoted by the ESC and the various stakeholders promoting inclusivity and diversity that should drive meaningful and sustained change in clinical trials and all evidence-generation methods, with the aim of securing generalizability of their results as to benefit all patients across sex, gender, ethnicity, rural and urban environments, geographies, socioeconomic context and health care systems.

Improving inclusion and diversity in clinical trials is gaining much attention but few initiatives are being taken and little resources are put into making it happen.

Programme

View Faculty Biographies

DAY 1: 5 July 2023 - 13:00 - 18:45

• 13:00 - 13:15 - Welcome from CRT Chairpersons - Prof. Thomas Luescher, ESC President-Elect Prof. Alexandra Goncalves (BMS)
• 13:00 - 13:15 - Welcome from meeting Chairpersons - Dr. Harriette Van Spall, Prof. Faiez Zannad and industry Chairpersons
• 13:15 - 13:30 - Introductory Lecture: Age, ethnicity, and socio-economic deprivation in CVD: global registries and repositories. Recording to come - Dr. Salim Yusuf (Zoom)

Session 1 – Trial representativeness matters (Moderated by Dr. Harriette Van Spall & Prof. Martin Cowie (AstraZeneca))

• 13:30 - 13:40 - Defining representativeness in clinical trials: when is a trial diverse enough? - Dr. Clyde Yancy (Zoom)

• 13:40 - 13:50 - Historically under-represented regions in cardiovascular clinical trials: why it matters - Prof. Faiez Zannad

• 13:50 - 14:00 - Ethnic representativeness in trials of cardiometabolic disease - Prof. Kamlesh Khunti

• 14:00 - 14:10 - Why an ethnic representation matters: a trial fibrillation/stroke trials - Dr. Eduard Shantsila

• 14:10 - 14:20 - Pregnant and lactating women in clinical trials: overdue for inclusion - Dr. Harriette Van Spall

• 14:20 - 14:30 - Patient perspective - Mr. Richard Mindham

• 14:30 - 15:10 - Panel discussion - All

• 15:10 - 16:00 - Breakout session 1 – 2 groups – 45 mins

  • Group 1: Trial conduct and execution: How to assure geographical representativeness and include LMICs - Lead: Dr. Kristine Buchholtz (NovoNordisk), Rapporteur: Prof. Habib Gamra
  • Group 2: How to overcome international guidelines poor applicability in LMIC? - Lead: Prof. Eva Prescott, Rapporteur: Dr. André Ziegler (Roche Diagnostics)

Session 2 – DESIGNING TRIALS FOR REPRESENTATIVENESS (Moderated by Prof. Faiez Zannad & Dr. Kristine Buchholtz (NovoNordisk)

• 16:20 - 16:30 - Artificial Intelligence/Machine Learning to guide 21st century clinical trial enrollment: are we there yet? - Prof. Martin Cowie (AstraZeneca)

• 16:30 - 16:40 - Registry based trials: the ultimate platform for representative enrollment - Assoc. Prof. Marion Mafham

• 16:40 - 16:50 - Adaptive recruitment and decentralized trial designs for clinical trial diversity - Prof. Otavio Berwanger

• 16:50 - 17:00 - Investigating heterogeneity of effect: Subgroup analysis: sin or opportunity? - Prof. Eric Vicaut

• 17:00 - 17:10 - Investigating heterogeneity of effect: Interim analysis to assess for representativeness: worth a try or just a tribulation? - Dr. Lehana Thabane

• 17:10 - 17:50 - Panel discussion - Prof. Faiez Zannad, Dr. Harriette Van Spall, and speakers Dr. Maciej Kostrubiec (EMA), Dr. Fred Senatore (US FDA) (Zoom)

• 18:00 - 18:45 - Breakout Session 2 – 2 Groups - 45 mins

  • Group 1: How industry can foster diverse enrollment in clinical trials: does trial design matter - Lead: Dr. Harriette Van Spall, Rapporteur: Dr. Thomas Hucko (Amgen)
  • Group 2: Should trial flow be stratified/reported by sex and ethnicity? - Lead & Rapporteur: Dr. Bettina Kraus (B-I)

• 18:45 – End of Day 1 - Outlook to Day 2

  DAY 2: 06 July 2023 - 08:15 - 12:30

• 08:15 - 08:30 - Summary of Day 1 – Outlook to Day 2 (No slides) - Prof. Faiez Zannad, Dr. Harriette Van Spall and Industry Chairpersons
• 08:30 - 08:45 - Report from breakout session 1 – 15 mins - Prof. Habib Gamra & Dr. André Ziegler (Roche Diagnostics)
• 08:45 - 09:00 - Report from breakout session 2 – 15 mins (No slides) - Dr. Thomas Hucko (Amgen) & Dr. Bettina Kraus (B-I)

Session 3 - DIVERSITY IN CLINICAL TRIALS LEADERSHIP (Moderated by Prof. Faiez Zannad & Dr. André Ziegler (Roche Diagnostics))

• 09:00 - 09:10 - Clinical trial leadership: where are the women? - Dr. Michael Gibson

• 09:10 - 09:20 - Meaningful engagement of sites and investigators in under-represented regions - Prof. Habib Gamra

• 09:20 - 09:30 - Developing clinical trial leaders for the 21st century (No slides) - Prof. Faiez Zannad with Dr. Guiomar Mendieta Badimon

• 09:30 - 09:40 - A map to close the diversity gap in clinical trial leadership - Prof. Angela Maas & Mohamed B Jalloh (prerecording)

• 09:40 - 10:20 - Panel discussion - Prof. Faiez Zannad, Dr. Harriette Van Spall, and speakers

• 10:20 - 10:45 - Break

• 10:45 - 11:30 - Breakout Session 3 – 2 Groups - 45 mins

  • Group 1: Training the future generation of trialists with emphasis on diversity - Lead: Prof. Cecilia Linde, Rapporteur: Prof. Martin Cowie (AstraZeneca)
  • Group 2: The role of industry sponsors in diversifying trial leaders and executive committees - Lead: Dr. Stefano Corda (Bayer), Rapporteur: Rebecca Ortega (Women as One)

• 11:30 - 11:45 - Report-back from breakout 3 (No slides) - Prof. Martin Cowie and Rebecca Ortega

• 11:45 - 12:30 - Summaries from 3 sessions and breakout groups; Wrap-up and take-home messages; Actionable Solutions for Inclusive Clinical Research; Next steps for a manuscript development (No slides) - All Chairpersons

• 12:30 – End of Day 2