Sites & Investigators: Critical to Accelerating Clinical Trial Efficiency
The successful completion of clinical trials involves hard work from a variety of stakeholders such as sponsors, Contract Research Organizations (CROs), vendors, etc. but none more than the investigators and sites themselves — as they are the true face of the trial. In the past, we’ve discussed why it’s important to have good relationships with sites and investigators, but today we will explore the role they play in the success of clinical trials as well as what sponsors can do to foster more collaborative environments.
According to an estimate by the Tufts Center for the Study of Drug Development (CSDD), it takes approximately 10 years and around 2.3€bn to develop a drug that achieves market approval. Furthermore, other studies and estimates calculate that approximately 90% of those costs are related to clinical trials. Unsurprisingly, most of these costs come from delays in site initiation and patient recruitment due to incorrect feasibility calculations.
Because CROs rely on few tools to find valuable sites and investigators, identifying and enlisting the right sites for each trial is arduous work. In recent studies, astonishing figures have been revealed indicating that on average, approximately 40% of sites under-recruit, and a further 11% don’t recruit at all. Even more surprising, studies show that half of sites and investigators that participate in a trial will not do so again — making the search for high quality partners even more difficult. How can CROs help sites excel in trial execution?
Some authors stress the importance of sites treating clinical research as a service equally relevant as patient care. Such philosophy highlights the importance to realize investments and have dedicated teams to ensure the site is prepared for new clinical trials whenever they come. A second group stresses the importance of building long term relationships with sites and working as a “single team” with them. Analysts and experts that favor this approach usually point to the sites that CROs and sponsors manage themselves. Additionally, they point out that partnerships based in transparent communication go a long way to support trial execution with referrals and access to sites, investigators and key opinion leaders if needed.
Truth be told, a “good” clinical site more likely than not combines both approaches to varying degrees. It is evident that a successful trial rests mostly on investigators with dedicated staff that understands the importance of clinical research, are well trained and highly motivated. Simultaneously, positive relations with sites clearly have positive long-term effects in the way investigators, site staff, CROs and sponsors collaborate. It also provides a framework of trust from which honest and transparent communication arises to raise issues in time and allows for some time and cost savings.
Sponsors and CROs clearly understand the importance of sites and constantly experiment with innovative ways to recruit, train and motivate them to deliver successful results. It would be interesting to see how sites evolve and adapt to other innovations such as site-less or virtual clinical trials, wearable devices and the relentless pursuit of ever-more orphan indications.
Stay tuned for the next KCR trends!