Behind the scenes: Site selection
By: Peter Fredette | May 02, 2016
How common misconceptions may create unnecessary delays, and how to overcome them.
Site selection for clinical trials is as much an art as it is a science. A good CRO will consider dozens of factors when working with trial sponsors choosing trial sites to be sure they get the right team together to deliver the most effective and efficient project. But much of this selection process occurs behind the scenes. The CRO team may be assessing and measuring dozens of criteria diligently, but when the sponsor only sees the list of candidates that make the final cut, they may not realize the depth and breadth of work that went into that selection process.
This can lead to misconceptions about how sites are chosen and what makes a site ideal for a specific trial. In my presentation at MAGI 2016 (Boston, May 1-4), I’ll be pulling back the curtain a bit and discussing some of these misconceptions and what sponsors and sites can do to participate in this process. Here’s a sample of what we will cover:
Misconception #1: You only choose sites you have relationships with.
It is true that we invest a lot of time, thought, and effort into cultivating relationships with research sites around the globe. Indeed, the strength of these relationships is one of the key benefits of working with Quintiles. We know what these sites are capable of – and what their limitations are – and we have worked closely with them in the past. But being on a first name basis with the site selection committee doesn’t guarantee any site a priority spot on a study list. While some CROs may only use relationships as a gut measure of ability, we prefer to take a more analytical approach.
Our site selection process weighs a number of metrics, the most important of which is access to patients. One of the most important priorities for any trial is a site’s ability to quickly and efficiently recruit patients. That ability depends on many factors including, expertise with the particular disease, the size of the local patient population, access to leading physicians, relations with the right patient advocacy groups, recruiting skills, and maturity of the overall operation. We also consider a site’s past success running trials, how long it has been running trials, the quality of data it produces, engagement of staff, and maturity of its governing boards.
Once we review all the criteria they are weighted and measured using sophisticated algorithms to generate a ranked list of the best sites based on the unique needs of each trial.
Having a relationship with a specific site is certainly factored into that equation and it can help us get a more accurate sense of other factors, such as their expertise with a disease, the skills of their staff, and the quality of their output. But it is still only one component of the equation. And even if a site ranks high on some lists, it may not rise to the top of others. Even if we know a site has demonstrated great skill in running trials for diabetes, for example, we wouldn’t assume they would be the best site for an oncology trial. Conversely, we may recognize that a site we know well has the necessary skills and experience to run a project, but the algorithm ranks that site below several others that have more experience, more collaborative governing boards, and/or access to a larger patient population.
Having strong relationships with trial sites is at the core of what we do. However, we aim to only choose a site for a trial if it is the right fit. Having that meaningful relationship with transparency and open dialogue helps us make sure the best sites are put forward for every project.
Misconception #2: Key opinion leaders (KOLs) always make the best site operators.
KOLs are physicians who are viewed by the healthcare community as leading influencers in a specific medical practice or disease. And without question, these are some of the most valuable thought leaders to engage in any clinical trial process. KOLs provide valuable insight into trial design, and can often provide unparalleled access to patient populations, patient advocacy groups, and research that will further inform the drug development process.
And yes, a KOL might also be the best person to lead a trial site. However that is not always the case.
As with the discussion above about relationships, our site selection process recognizes and weights the value of KOLs, but our ultimate goal is to choose the best possible site and Investigator to run the trial based on all of the defined criteria. In many cases we find that a Key Productivity Leader (KPL), is the best candidate. A KPL is a physician investigator who actively seeks out and performs clinical research trials and has demonstrated significant predictability in enrollment, efficiency in delivery, and high quality output. Our experience shows that when we can identify a KPL, backed by an institution dedicated to quality and efficiency, they are most likely to deliver a faster more efficient trial.
However, even if a KOL is not identified as the best possible leader for a trial, we will always strive to engage them with the research, and to harness their expertise and network to help spread awareness about the trial to the patient community. By working collaboratively with both KOLs and KPLs, we can harness the best of both experts to deliver a more efficient and effective trial experience.
Misconception #3: ‘First patient in’ is the most important metric.
The adage ‘time is money’ is especially true in clinical trials. According to the Tufts Center for Drug Development, it now costs an average of $2.6 billion to develop and gain marketing approval for a new drug, and 90 percent or more of that drug's development costs are incurred in Phase III trials.
. If we can shorten the time to deliver these trials we can cut costs from the development cycle and speed time to profitability. So of course ‘first patient in’ is an important metric for any trial design. The faster you start recruiting the sooner you start treating patients and the sooner the trial is completed – at least that’s the theory. However, when one speeds through the early planning and due diligence process to get to that first patient, they can sometimes create unnecessary obstacles that add time, cost and risk to the project. For example, without careful vetting, they can end up with a protocol that is unnecessarily exclusive or overly inclusive; choose a site only to find that the staff isn’t properly trained; or pick a region that has a deep patient population but won’t meet global regulatory requirements. These of course will negatively impact the trial in the end, undoing any incremental value generated from rushing to the recruiting phase.
While ‘first patient in’ will always be an important measure of progress, ‘last patient in’ is often the more accurate metric to measure the ultimate speed and effectiveness of a trial. That last patient is a more accurate indicator of the trial’s duration and demonstrative of the success of the overall recruiting effort.
Taking the necessary time up front to do the proper due diligence, to vet recruiting criteria, and to choose the best site for the project may extend the time to first patient, but will likely speed the time to last patient as well, and that translates to a faster trial and lower costs.
When sponsors, CROs, and sites work together collaboratively as partners, misconceptions fade and we all move closer to delivering the best, fastest, cheapest, and most productive trials possible. It may take a little more time in the beginning, but the long term benefits may just be worth the effort.