INNOVATIVE EARLY CLINICAL TRIAL DESIGNS AND DEVELOPMENT STRATEGIES: EVOLUTION OR REVOLUTION?
Thursday 6th May 2021
NOTE: This will be held as an online
meeting. Details of how to attend will be sent to delegates after
A move away from more “traditional” early phase clinical trial designs and incorporation of biomarkers
is increasingly critical for taking go/no-go decisions during drug development to avoid costly late stage
failures. Both in terms of financial cost and, more importantly, the cost to patients by being given
ineffective experimental medicines.
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. Online
networking facilities will be available.
- Penny Ward (PWG Consulting): Evolving the oncology early drug discovery paradigm
- Mark Field (Eptiva Therapeutics): Creating a precision
analgesic™ approach to enhance success in early clinical
- Morten Karsdal (Nordic Biosciences): The Use of Biomarkers
in the Design of Early Clinical Studies in Development
- Kristian Brock (UCB Pharma): Is better? Toxicity and response outcomes from dose-finding trials in cancer