The TMF is the official record of the clinical study for Regulatory Authorities, be it…
It is no secret that Canada’s presence as a key player in the field of pharmaceutical drug development is rapidly growing; with approximately 5,728 active clinical trials in the country as of April 2019 (1) – capturing over 4% of global trials (2) – Canadian research teams are being consistently recognized for their quality and high level of expertise among innovative drug companies. Clinical trials in Canada will inevitably continue to grow, especially given the extensive network of Canadian academic health institutions and research centers available to such companies, which includes 17 medical schools, 40 groupings of academic healthcare organizations, and over 13,600 researchers (3).
That said, with such a vast number of high-quality choices comes a unique set of challenges – how does an innovative drug company navigate and leverage the Canadian health network in order to achieve the ultimate goal of health regulatory approval for its products? There are so many researchers available across the country, and one of the main challenges that these companies face is identifying and narrowing down the best investigators for a given trial in a time-effective manner – i.e., in the feasibility and start-up stages of the clinical trial.
One hassle-free solution is to work with clinical research organizations (“CROs”) that are experts in both: the particular indications being targeted by these innovative drug products; and the Canadian health landscape relating to a specific disease state. Many innovative drug companies, or Sponsors, are already taking advantage of these niche and specialty CROs due to their ability to leverage the local health landscape, provide customized services to Sponsors, and for their expertise in nuanced and complex disease states; in fact, recent reports indicate that Sponsors are outsourcing 10% more clinical trials per year to niche and specialty CROs rather than maintaining these operations in house (4).
Niche and specialty CROs are often better-suited to attract Canadian investigators (and their patients), as their focus on a smaller number of trials in a specific field allows them to build and maintain personal relationships with Canadian sites that specialize in the same area. Not only are these CROs able to demonstrate to principal investigators that they have the necessary expertise to provide the best patient-focused trial possible, but their repeated work with the same sites helps them understand the needs of pivotal healthcare providers beyond only the principal investigator.
More important for Sponsors, this relationship-building process allows these CROs to streamline and optimize clinical trial efficiency; while it cannot be denied that the principal investigator is an important part of bringing a clinical trial to life, “site engagement” – i.e., having institutional knowledge of a site’s capabilities, schedules, staff, changeovers, and deadlines – is equally important, as it cuts down on time spent in the feasibility / start-up stages of a trial. Given the increased number of trials competing for the same patient populations and sites in Canada, Sponsors need to be “picky” about the CROs that they choose to assist them with their trials.
According to a site-selection study published in Applied Clinical Trials by Tufts CSDD in 2016, 69% of respondents believed that the delayed responsiveness of sites and investigators during the feasibility / start-up stages of a clinical trial significantly contributed to an ineffective site selection process (5). Which is why, at Scimega, we believe that “site engagement” extends beyond the duration of a clinical trial. We continue to maintain relationships with our sites in the Canadian oncology space even if we have no active studies with a given site – this is simply an investment we consistently make to ensure that we continue to lead the field with respect to patient and site intelligence. By doing this, we put our clients in the best position possible for study success, as research has shown that:
- Sponsors that rely on their CRO partner for site recommendations, which we would not be able to do without keeping up-to-date on Canadian oncology site activities, complete site selection 1.6 weeks faster than those that do not use a CRO partner (6); and
- Sponsors using CROs that have already established relationships with sites have been shown to shave 39 days off the study start-up time (7).
Ultimately, a lot of factors go into recommending a site for a clinical trial, and when such a recommendation is made, it is up to the Sponsor to entrust their partnered CRO for the best results.
Contributed by: Chantalle Willie B.Sc., CCRP
(1-3) Ask us about Sites we work with: email@example.com
(4 & 7) CROs Deliver Shorter Cycle Times, Says New Tufts Report – March 11, 2019
(5) Lamberti M.J., Chakravarthy, R.; Getz, K. Assessing Practices and Inefficiencies with Site Selection, Study Start-Up and Site Activation. In. Applied Clinical Trials: UBM Plc; 2016.
(6) Evaluating New Data-Driven Approached Informing Global Investigative Site Selection