Thursday, September 8, 2016

Strategic Partnerships in Clinical Trials [Whitepaper]

Are Strategic Partnerships in Clinical Trials Living Up to What They Promised in Terms of Cost, Efficiency and Service Quality?

Whitepaper Overview:

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 percent 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.

Success is ideally assured when both partners work together to achieve their common objective as well as assist each other to achieve their individual objectives. However, most partnerships are neither ideal nor completely successful. Similarly Sponsor –CRO partnerships are fraught by failure to align partner expectations and goals, failure to communicate adequately leading to delayed clinical trials and subsequently greater costs.

Today every field of medicine is highly specialized e.g. otologists, rhinologists, cardiologists, pulmonologists etc. Similarly Sponsors and CROs too are highly specialized and can offer their individual expertise to the field of drug /device development. The rocky road of strategic partnerships can be smoother if both partners were to work as a team to develop valuable drugs to alleviate diseases.

Veterans in the biopharmaceutical –CRO market place have a few pearls of wisdom for successful Sponsor – CRO partnerships:

  • Align mutual expectations
  • Develop a common direction for the partnership
  • Develop mutual respect for each other
  • Improve communication. Avoid postponing discussion and problem solving
  • Learn from each other’s mistakes instead of finger pointing
  • Prepare management manuals to preserve and perpetuate best practices
  • Foster long term relationships which enable CROs to offer volume discounts and consistent rates

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