Impact of the clinical trial design strategy on product market uptake and overall commercial success - ISPOR Europe 2018

Impact of the clinical trial design strategy on product market uptake and overall commercial success - ISPOR Europe 2018

Recent breakthroughs in the space of cardiovascular diseases, oncology and
some rare diseases have revolutionised the treatment paradigm and improved
outcomes for many patients. Bringing this into the context of regulatory approval
and health technology assessments (HTA) across Europe has meant that proving
a signicant level of efcacy against existing comparators rather than placebo is
increasingly hard. Thus, pharmaceutical companies increasingly face difficulties
designing their clinical trials in a way that corresponds to the needs of regulators,
whilst at the same time optimising the overall commercial success of products
and minimising costs associated with their clinical trial programmes. There is
therefore a growing need for pharmaceutical companies to re-evaluate their trial
design strategies. In light of these considerations, the study aims to assess if a
broad, investment-heavy clinical trial strategy results in broader market access
and improved commercial success, and to provide a set of recommendations
on possible winning trial design strategies.

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