Risk-based site selection model could cut trial costs

In theory, running trials in multiple countries can improve access to patients and accelerate recruitment rates. However, poor site selection can nullify the potential advantages, according to a new study.

The study, published in the European Journal of Operational Research, examined how sponsors go about selecting research sites and the common challenges they encounter - and contract research organizations (CROs) play a major part, according to the authors.

“Pharma companies can choose to self-manage their trials, outsource the administration of trials to contract research organizations, or use a hybrid approach.

“Depending on specific contracts, CROs can provide different types of services to pharma companies, from engaging the test sites, training staff on how to administer the trial protocols, providing them with clinical supplies to coordinating the data collection,” the authors wrote.

Lack of knowledge

According to the study, one of the main selection challenges is the tendency to choose research sites based on location without detailed knowledge of their operations, access to potential participants, and therapeutic experience.

“Sites in one region can be very distinct from sites in another area. Yet, a common mistake in selecting sites is to rely on too little knowledge or subjective data,” the authors wrote, adding, “Poor selection decisions can lead to study delays and prolong the time to market for life-saving treatments.”

Instances where a lack of knowledge has a negative impact include situations where sites are selected based on personal or corporate preferences, or because regulations in the selected country allow shorter start-up times.

And the negative impacts of such decision-making can be significant, according to the authors. They cite the addition of sites during enrollment, replacement of countries or sites that fail to meet expectations, or extension of recruitment timelines as examples.

The solution

To avoid such issues the authors suggest sponsors use a risk-based framework for selection that takes factors such as uncertainty in recruitment time into consideration.

“This framework aims to minimize the system-wide costs for a clinical trial while achieving a high probability of completing it within a recruitment deadline.

“To execute this framework, we adopt the Poisson–Gamma patient recruitment model, whose parameters can be conveniently estimated via the historical data of similar trials via moment matching. Further, this model facilitates the evaluation of the risk constraint on recruitment time so that the corresponding optimization can be efficiently solved.”

Unsplash/Josh Appel