%Need to distinguish that this isn't about drug development specifically, but
% more around clinical trials progress.
% Thoughts:
% - What types of failures do clinical trials have an why do clinical trials fail?
% - What is cited in termination reasons?
% - Discussion on different types of failures:
% 1. Failure to find safe and effective drug
% 2. Failure to collect enough information to determine 1
% - recruiting
% - New information (other studies, changes in standards of care, etc)
% 3. Failure due to other operational/strategic concern.
% - Issues with PI/Sponsors
% - profitability expectations
% - Financial support
% Trials can fail due to issues in one of four categories
% - Scientific: The compound-indication combo is not sufficiently safe or efficatious
% - Strategic: The result from the trial won't meet the company's strategic needs. Profitability for the most part or entry into a drug category they don't want to invest in.
% - Operational: They can't bring resources to bear to achieve goal, e.g. site planning, PI's, delivering enough financial support, etc.
% - Tactical: The plans to discover if the approach is scientifically valid are insufficient. Study design, enrollment strategies, etc.
% The literature examines many different aspects of these.
% strategic influences: elasticicity of innovation, demand pull, patents, etc
% Strategic vs scientific khmelniskaya, hwang.
% operational: Adam George Interview
% tactical: enrollment prediction.
% - Discuss how most studies are about clinical trials as part of the drug development pipeline.
% - Review what we know about causes for failure.
% - Things that correlate with failures. (adams)
% - Causes for failure (khmelnitskaya & hwang)
% - Then talk about studies on clinical trials themselves.
% - Interview with Adam George
% - Poor studies of enrollment prediction.
% -
% - Then talk about what drives approvals/clinical trial activity for drugs
% - Elasticity of innovation
% - No demand pull for novel drugs, but yes for derivatives
% - Population and Market size interact & drive development (jointly determined)
% - This doesn't apply to single trials though
% -
% - Sumarize
% - Thus when trying to study what affects clinical trials we must separate
will king
2 years ago