According to new research, government level regulatory changes have a significant impact on clinical trial success rates.
The study – conducted by researchers from Mackenzie Presbyterian University in Sao Paulo, Brazil – looked at the impact state regulations have on sponsor and CRO ability to conduct trials.
The aim was to determine how changes to rules governing clinical trials impact drug availability.
“Formal institutions, at the country analysis level, can influence clinical trials performance, promoting or restricting the investment in new clinical trials in countries, directly impacting the availability of new medicines, and therefore the life quality of populations.”
With this in mind, the authors suggest “pharmaceutical companies and their executives consider the comparative analysis of the countries’ regulations and their impact in clinical trials before new investments in their development in different countries.”
Strategic impact
The authors also looked at how legal revisions impact trial efficiency and success rates, particularly for sponsors and CROs engaged in strategic partnerships.
“Regulation is made up of a set of formal institutions, such as codified rules, which aim to determine social actors’ practices. Strategic alliances are long-term cooperative relationships voluntarily established between two or more autonomous companies with shared interests and goals to create competitive advantage.
“Clinical trial strategic alliances are organized according to the contractual relationship and parties’ relational capabilities that aim to overcome difficulties in the partnership activities and ensure intercompany cooperation, reflecting on organizational efficiency and effectiveness, and impacting on alliance performance.”
The key finding is that any uncertainties – such as those introduced when regulations change – can have a negative impact on strategic alliances.
The authors write “regulatory mechanisms that increase bureaucracy in imports can promote the decrease of efficiency and effectiveness of the clinical trial, through reducing its speed and amplifying its time, therefore compromising its performance.
“The instability of the rules can also have an impact on the performance of strategic alliances by increasing uncertainties and costs.”
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