The studies executed by the Tufts Center for the Study of Drug Development (Tufts CSDD), clearly show the dependency between ‘bad’ Clinical Protocol designs and increase of the execution costs and lower study performance.
By their estimates, on annual basis, the sponsors are spending between US$4 and $6 billion in direct costs alone, to administer procedures not related to either primary of secondary key end-points and regulatory requirements. That would translate to approximately $1.7 million additional cost for an average Phase III study [1].
On the study performance front the impact of over-complicated study designs results in lower patient recruitment, retention and study cycle times. The results showed, that on average, the clinical duration of a trial with complex trial design is increased by 64%[2].
Even though, the benefits of reducing the study complexity seems clear, large pharma organizations, that would benefit the most from that reduction find it very challenging to make that transition. The reason may vary and typically include not having appropriate tools or processes to make that change.
We at intilaris, have been working extensively on this topic in the real-world of large pharma organizations where ‘the rubber meets the road’ and have been a partner in making these changes. Our approach enables this change from the two crucial aspects:
- Providing appropriate tools
- Providing appropriate resources
Our tools have been developed and configured to enable the Clinical Protocol Teams to get a clear overview of protocol complexity and thereby being able to raise relevant questions as to the design complexity. Such early transparency on the critical protocol elements will enable the teams to optimize the study design and reduce the costs of executing the study. Our tools are build to conform with our Structured Protocol Framework (SPF) that is used to capture all elements of a Clinical Protocol essential for study execution and any documentation view of that information can be completed at a later point in time and for the regulatory purposes.
In terms of resources, intilaris has established the Protocol Centre of Excellence (PCoE) organization. The PCoE applies the principles of Structured Protocol Framework (either with our tools, other vendor tools or through a simple tool application, like excel) to enable our customers to derive the benefits of the Structured Protocol and start reducing the average study cost, improve the patients recruitment and retention and reduce the study cycle time to get the study results and drugs to market faster.
[1] Getz K, Stergiopoulos S, Marlborough M, Whitehall J, Curran M, Kaitin K. Quantifying the magnitude and cost of collecting extraneous protocol data. Am J Ther 2013.
[2] Getz K, Wenger J, Campo R, Seguine E, Kaitin K. Assessing the impact of protocol design change on clinical trial performance. Am J Ther 2008;15:449–56.
