Clinical Trial Site Performance Factors To Save Time And Money

By Linda Martin, founder and president, KMR Group

Selecting the top performing sites is an ideal goal for every trial.  However, the components of a top performing site vary according to who you ask.  Often, sponsors and CROs tend to choose familiar sites or those that are easier to engage from an administrative perspective. These sites may respond quickly to paperwork — or whichever processes your CTMS supports — but they are not necessarily sites with the most patients or fastest recruitment times. Those that rely on sites which have been used before are less likely to evaluate these sites against their peers, or for consistency in performance.  Often the assumption is that if the site was used in the past, it must have at least average or above average performance.  But we know that is not the case.  Differences in performance by the type of site and the type of trial are frequently overlooked in the planning process.  By incorporating the right site-specific performance factors in the site selection process, biopharma companies and CROs are able to enhance their site selection, resulting in faster and more efficient trials.

What’s In A Site?

Investigative sites are realizing they need to make their capabilities known.  But with varying interests and signals from pharma, sites themselves often face too many promotional directions.  Should the experience of their lead investigators be the primary focus?  Or is it their laboratory or administrative technology improvements?  What about their experience, or location and access to appropriate patient populations?  These are important criteria when evaluating sites. 

Additionally, the performance at the site may be of high interest to sponsors, yet it is not something that most sites would seek to establish as a core competency.  Many of the recent industry-wide site collaboration efforts are choosing to focus on efforts that will reduce the administrative burden of site selection, rather than differentiate sites for a data-driven site marketplace. This makes the job of sponsors and CROs involved with site selection especially difficult. It is no wonder why the habits of selecting sites that a company has worked with in the past or those that seem administratively efficient or are so commonplace.  However, there is more to consider, and the information is within reach.

Site Performance Factors

Site performance factors include the site’s specific experience within a given disease area or indication, as well as their associated performance. Although site directories are utilized in the industry to find out which sites are active in different therapy areas, they are often vague and broad-based.  Knowing more precisely if a given site has experience running registration-based trials with a specific disease or patient population and the extent of that experience is extremely valuable. 

The type of site should also be considered.  In some diseases, it is more common for trials to be conducted at institutions instead of a doctor’s offices.  For example, many oncology trials take place at large institutions, which generally take longer to randomize patients. This may increase the time it takes to randomize its subjects, but in general, these sites have access to more patients and, sometimes, more specifically, to the right patients. 

Other site performance factors include the time it takes to get started, and the ability to assess the individual site’s performance on metrics, such as subjects randomized and randomization rates.  If sponsors can identify specific sites that consistently deliver more patients in a short amount of time, this will greatly enhance site selection.

Incorporating these site-specific KPIs into the site selection process may be a change for some since the current selection process is fragmented, often involving various parties, such as those responsible for contracts, patient enrollment, as well as site relations.  Still, the needs of patients, not to mention the priorities of biopharma, require an informed site selection process.

How To Balance

Balancing these apparently diverse priorities of choosing the best site might depend on the trial.  In some instances sites are brought in at the end of the trial to compensate for underperforming sites or site plans. In these situations, selecting sites that are quick to randomize subjects is a high priority. Those involved with site selection should be able to use industry data to help identify these “top performers” based on the criteria most important for their specific need.

Effectively integrating key site performance factors into the site selection process will help trials be more efficient, saving time and money.

Linda Martin is a founder and President of KMR Group, a firm specializing in biopharmaceutical R&D performance, data and analytics. Linda has a Master of Management degree from Northwestern University’s Kellogg.