The Case for a Holistic Approach to Transforming Clinical Trials
A new survey of pharmaceutical executives and professionals by ICON and Informa Pharma Intelligence, supplemented by desk research conducted by ISR Research, provides valuable insight into key clinical trial challenges and potential solutions.
We explore the key challenges, and those areas identified by industry experts as having the most potential for generating savings and improving trial efficiency, and how digital disruption is forcing change.
Adopting individual initiatives and tactics can improve clinical trial efficiency, but the potential is even greater when they are applied in a coordinated fashion to reimagine and reinvent the R&D enterprise.
Whilst our survey shows that companies realise the need for a holistic effort to transform trials, only one in five survey respondents stated their organisation currently has a holistic/integrated approach to drive clinical trials transformation. In too many organisations, efforts remain siloed and therefore potentially not delivering their full potential for full process efficiencies and economic value.
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Top 3 industry challenges:
43%Regulatory Approval Delay/Changes
43%Site start up
Infographic: Survey highlightsView Infographic
With development cycles becoming too long, trial complexity increasing, and greater scrutiny of the economic value of new treatments, pharma R&D business models are under significant pressures to improve R&D efficiency.
These challenges largely result from an outdated clinical trial model. The traditional approach of three discrete, fixed trial phases designed for testing mass-market drugs often is not viable in today’s increasingly competitive, value-based therapeutic markets. It lacks the flexibility, analytic power and speed required to develop complex new therapies targeting smaller and often heterogeneous patient populations
The cost pressures on drug development are driving the search for savings. Whilst large-scale operational efficiencies are being instituted in many pharmaceutical organisations, efforts need to be integrated if they are to be effective.