This exclusive whitepaper explores how strategic partnerships have impacted clinical trials - both the benefits and the challenges - and the role they are going to play in the future.
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"The journey of a drug or device from its birth to the time it reaches the patient is long and arduous. The longest and most expensive part of the journey is during drug development and clinical trials. Only 5% of drugs being developed actually make it to the market.
Traditionally clinical trials were conducted in-house by the pharmaceutical companies. They employed full time personnel for conducting trials. Over time, the process of conducting clinical trials has become increasingly complex due to multi-center recruitment, involvement of clinical investigators in several centers, new regulatory guidelines and shift in demographics of trials from usage heavy countries like USA to clinical trial naïve patients in Africa and Asia. Concomitantly pharmaceutical companies under pressure to reduce staffing costs with smaller budgets to conduct clinical trials are outsourcing their drug development to contract research organizations who are help conduct clinical trials at a lower cost. This has lead to a trend of an entire smorgasbord of partnerships from tactical to strategic between pharmaceutical and biotech sponsors and CROs.
In the last decade between 70 -90 % of the sponsors have entered into a partnership with a CRO. According to a Quintiles study, partnerships range from tactical (“fee for service”) to preferred (“reduced price fee for service”) to partnering (“risk sharing and shared milestones”) to alliances (“sharing both profits and risk”) to integration (with maximal closeness and mutually beneficial relationship). In practice, partnerships are a mix of both tactical and strategic components depending upon the needs of the Sponsors and the CROs."
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