Selecting the right sites can be the difference in having a study that runs with a smooth operational flow or a study filled with rescue sites and their associated delays. We have come up with a list of seven strategies you can employ the next time you are identifying the best sites for your trial.
Having a clear sense of what you are seeking can greatly guide your site selection. Do you know how many sites you need overall, by country, and how much room you have for adjustment? For example if you realize you can recruit more subjects in a given country, can you allocate more resources away from one country to the promising country?
Know the metrics
Selecting sites without understanding the site metrics for your trial is not an advisable strategy. Maybe you know you need to find sites in France for your upcoming Phase II Lung Cancer study. If you knew the site metrics then you would know that at any given site in France you could expect to randomize 3 subjects. Later if a site in France was saying they could provide 10 subjects, you would be able to question their assumptions.
Internalize your internal priorities
Is it important for your company (or this trial) to use sites that you have worked with in the past? Are relationships more important that the performance of the site? While it may be common to work with several sites who are average performers, is your organization open to working with new sites instead? There is always a balance of trying to use the sites with the most promising performance, with those sites that are reliable for being average – this is where knowing the priorities of your company come in to play. What policies have informed past decisions and is there room to update these as you progress your site selection strategy?
New site thinking
Using a site that is new may involve more work at the outset, but will be well worth the effort for this study and any possible future collaborations. With new cross-industry developments aiming to minimize the administrative burden for both sites and sponsors and CROs, choosing to work with a new site can be an excellent decision. Use individual site scorecards to inform your site selection by assessing the site’s performance in past trials for your same disease.
Experience or performance or both
Some sites have literally dozens of trials in the area of your study. Other sites may have an n of 1. Or perhaps no experience in your indication but experience in the same therapy area (TA) or disease area (DA). When choosing a site, do you want to choose sites with a proven track record in your indication? We will call this “experience” – an experienced site for your indication. However this does not account to how well the site performed. Some sites worth considering may be excellent performers at the TA or DA level, despite the fact they do not have experience (yet) in your indication. With the right information you can aim to find the sites that have both an ideal level of experience and performance.
Going back to our example of our site in France saying they could provide 10 subjects when you know the median performance at any site in France is 3. When in discussions with that site you could learn why they think they could provide you that many subjects. You could mitigate risk by planning for fewer subjects. View that site’s particular performance for past lung cancer studies to know their median performance for the Industry to further guide your planning.
Be protocol specific
Trials have different resources meaning the basis you use for assessing site performance, and thus your site selection, can be quite different for each trial. If recruiting a large number of subjects is the highest criteria, keep this in mind as you evaluate historical site performance. Or maybe your priorities include a balance of the time it takes for patient randomization and the number of subjects the site it can recruit. You want (need) sites that can randomize in a respectable time and with a reliable number of subjects. Knowing the unique priorities of the trial can help you to select sites that are best suited to deliver for your trial.
The next time you are identifying the sites for your upcoming trials, use one or all of these seven strategies. The more informed the better. Wishing you smooth operational flow in your site selection.