Adoption of more innovative study designs have several advantages including flexibility, efficient use of patient numbers at sub-optimal doses, speed and an ability to allow adaptation to the trial and/or statistical procedures after initiation without undermining validity and integrity. In addition, it is important to seek involvement of patient advocates early in the clinical trial design process to ensure that patient needs are met and to avoid poor accrual and compliance.
Inclusion of well-defined pharmacodynamic and phenotypic biomarkers can also help to aid the critical decision-making process by showing whether the drug is behaving as expected from a biological perspective and take decisions on recommended dose(s) for further development. This type of data can provide the confidence to continue clinical development even in the absence of significant clinical efficacy in these early stages.
This virtual, half-day meeting is aimed at students, clinicians and practicing professionals from academia and industry looking to gain an understanding of how these designs and concepts are being applied across many therapeutic areas, including oncology, fibrosis, respiratory and inflammatory diseases.