Risks

Clinical trials are the pivotal stage in the product development timeline and can determine its fate, and in some cases that of the company itself. Sponsors that fail to fundamentally reexamine how trials are being designed, executed and managed with an eye toward maximizing efficiency, value and the prospect of a favorable outcome, open themselves to:

• Being at the mercy of service providers that are not customer-focused.
• Having trials done that are too costly, ill-designed and mismanaged
• The potential of losing a safe and marketable treatment to mistaken conclusions.
• Exceeding the trials budget due to unnecessary, unanticipated cost overruns.
• Not selecting the very best investigative team because of misplaced priorities
• Missing out on a marketing window essential for competitiveness because of delays.
• Generation of poor quality data that can lead to misjudging effectiveness.
• Losing communication with service providers.
• Missing out on new, cutting-edge approaches to trials.

Opportunities

A revolution of sorts is taking place in the clinical trials world. As tired, old ways of approaching them are questioned, sponsors that scrutinize partners better and take more ownership of the process can boost the odds of:

• Restoring some of the relationship balance lost with the emergence of preferred providers.
• Dictating more of the key terms of contracts with providers.
• Gaining more hands-on involvement in how trials are developed and carried out.
• Being able to develop study designs that generate more feedback that can course-correct trials in real time.
• Putting more trials into the pipeline as times and costs are compressed.
• Gaining the ability to hire and manage multiple CROs and other providers as conditions dictate.
• Better scrutinizing providers on the basis of their suitability and track records.
• Better leveraging the information potential of the human resources element of trials – the subject participants themselves.
• Tapping into the power of social media and Big Data for patient recruitment and data analysis.
• Gaining confidence in future trials processes as knowledge expands.