Aligning interests between CROs and Pharma – how to get more out of site feasibility and investigator selection

Aligning interests between CROs and Pharma – how to get more out of site feasibility and investigator selection

One of the main reason for which most clinical trials fail and get terminated is due to slow patient recruitment, also known as low accrual rates. As anyone who works in the industry knows, the early process of selecting sites and investigators for a clinical study is one of the most critical tasks in running trials, as it forms the foundation for successful recruitment rates.

Since we work with a wide range of industry-leading pharmaceutical companies and CROs, we have aggregated insights and learned about the headaches they experience throughout the execution of this process. What perhaps is the most striking is the lack of transparency and alignment of interests between the parties involved. This blog post is the first of several during this fall. We begin here by highlighting the issue at hand. As we move forward, we will discuss different ways to improve site and investigator selection.

A brief general overview of the process for site and investigator selection performed by a pharma (or biotech) and an associated CRO is outlined below.

What the site feasibility and investigator selection process looks like

  1. The sponsor asks the CRO(s) to conduct a feasibility study, if not performed internally
  2. The sponsor suggests who should be the principal investigator, as well as the country coordinator(s) who will act as a liaison between the investigative site and sponsor and handles most of the administrative responsibilities of the trial.
  3. The CRO(s) appoints a monitor to collect information about potential sites and investigators
  4. The monitors use the sponsor list of suggested sites and investigators along with other resources and conduct feasibility interviews
  5. The CRO’s project manager fine-tunes the lists and decides which centres and investigators to propose to the sponsor.
  6. The sponsor accepts (or rejects) the selection

It is evident that the feasibility study is paramount for the selection of sites and investigators, and by extension, for enabling a successful trial. The overall outcome depends heavily on the list of investigators generated by the CRO. The main problem with this is that there is an inherent difference in the short-term interests between Pharma companies and CROs, which ultimately can lead to an early poor selection process. What do we mean by this?

While each sponsor would like to work with the right investigators to maximise their trial success rate, a CRO normally wishes to minimize the time and resources spent on the feasibility study, which typically is unpaid and usually part of an intensive bid/procurement process. With multiple CROs fighting to win the contract, there is no assurance of who will win the bid. A CRO must, therefore, operate with great efficiency and high speed throughout the feasibility process. The time pressure and competing elements of the process create low incentives for the CRO to execute an extensive feasibility study. As most CROs are in sales mode (as they should be), they are unlikely to be transparent about the how the feasibility study was carried out, or the thoroughness details of the approach.

As a consequence, the CRO often minimizes travel and personal visits and instead opts for phone/fax/email interviews. The dependence on historic performance of sites and investigators, such as historical recruitment rates and already established personal contacts, is often very high. While past enrolment rates may serve as a great proxy, it could easily lead to a biased process which is based on conditions and information that was relevant in the past and not today. The competitive landscape for an indication may have changed, investigators could have relocated etc.

How can you work smarter?

We work with customers on both sides of the fence to address this. Many pharmaceutical companies approach us looking to speed up their internal selection process and get a more holistic understanding of the global landscape. Mainly with the hopes of faster producing more extensive and vetted lists to hand over to CROs, and be able to internally validate the proposed site from CROs. At the same time, CROs turn to us looking to increase their operational efficiency and quality in their feasibility work and get continuously updated data on the global landscape of sites and investigators into their systems.

So, how can you increase transparency in and commitment to the feasibility study and what best-practices are used by progressive frontrunners in the industry on both sides? Stay put for a series of blog posts on this topic. In the meantime, reach out to us to discuss this topic further and subscribe to our newsletter to make sure you get all future updates delivered straight to your inbox.

References

  1. Easterbrook PK, and Matthews DR. Fate of research studies. J R Soc Med. 1992 Feb;85(2):71-6.
  2. Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007. J Clin Oncol. 2010 Dec 10;28(35):5197-201.
  3. Stensland KD, McBride RB, Latif A, Wisnivesky J, Hendricks R, Roper N, Boffeta P, Hall SJ, Oh WK, and Galsky MD. Adult cancer clinical trials that fail to complete: an epidemic? J Natl Cancer Inst. 2014 Sep 4;106(9). pii: dju229.
  4. Williams, R J., Tse, T., DiPiazza, K., and Zarin, D A. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. PLoS One. 2015; 10(5): e0127242.
  5. Demetor, J. (2002) Selecting Sites and Investigators: An Approach for Central and Eastern Europe.
  6. Naybour, P. and Joby, R. (2011). Feasibility Focus. Samedan LTD Pharmaceutical Publisher, (147).
Felix Jansson

Marketing and Account Manager