ER3 – Update on the clinical trial landscape

Link to EAHP Statements
Section 6 – Education and Research: Statement Statements – 6.5

 Abstract
For many years randomised controlled trials (RCTs) were deemed the gold standard for evidence-based medicine, mainly due to their ability to prevent bias through randomization. However, the landscape has changed, and RCTs are now facing challenges such as time constraints, high costs, and ethical barriers.  To overcome such barriers, in recent years alternative clinical trial designs have emerged, each with its strengths and weaknesses.
Under the master protocol framework are grouped new clinical trial designs that investigate one or more than one treatment in multiple subgroups of a study population as opposed to the traditional RCTs, which mostly investigate one drug in one study population. The master protocol clinical trials include: basket trials, umbrella trials, and platform trials.
This seminar will present the changing perspectives of clinical trial designs, comparing classical trial designs with newer trial designs and examining the role of the master protocols in the clinical trial landscape. In addition, a brief outlook on the possible use of artificial intelligence in clinical trials will be given in this seminar.

Learning objectives
After the session, the participant should be able to:

• List the various clinical trial designs currently available in clinical research.
• Outline the strengths and weaknesses of the different trial designs.
• Discuss the role of the clinical trials within the master protocol framework in the clinical trial landscape.
• Have an idea of how artificial intelligence could be used in clinical trials in the future.

Educational need addressed
This seminar addresses the changing perspectives of clinical trial designs and how clinical research is shifting from classical RCTs to newer trial designs.

Keywords
Randomized clinical trials, master protocol framework, basket trials, umbrella trials, platform trials.