Before a clinical trial begins, two of the biggest obstacles sponsors face are study start-up and patient enrollment. Experts say, on balance, study start-up rarely ever goes according to plan and it doesn’t take very long to fall significantly behind. While it’s natural for sponsors to have a mindset of ‘first patient, first visit’ before starting a trial, the priority for any company should be to ensure everything is in place because if the start-up is delayed, the knock-on effects could be detrimental to the study.
Once a sponsor has all the approvals it needs and all their sites are enrolled, patient recruitment can be a big issue. Trial investigators and sites may promise a certain number, but it’s always best to come up with contingency plans in the event they are not on target. After all a site may have competing studies taking place concurrent to yours, or they struggle to run the trial on budget. Nevertheless, the ongoing problems with patient recruitment ultimately boils down to having an effective site selection policy.
So what goes into selecting the right site? Here are four things to consider:
1) Do a thorough site qualification visit
This is really critical in identifying sites that are really engaged and really on board with meeting the timelines. Ensure the staff onsite meets the right requirements and have a proven track record of getting sites up and running quickly, as well as delivering results on the agreed timeline. Critically, site staff must be qualified and have experience in running similar trials. Doing a thorough site qualification visit is crucial task that can aid identifying sites that are a good match for your study.
2) Whittle your options down and prioritise them
Once sites are identified, prioritize them. Do a triage and discern which sites are going to have the shortest start-up timelines. Some have a number of different internal committees and that must be accounted for in the qualification phase (e.g. scientific review, safety review, radioactive review, etc.). So whether they are doing multiple reviews in parallel or in sequence can make a 4-6 month difference in the start-up of the site.
3) The ability to recruit and retain patients
It is no secret that recruiting patients for a trial is a thorny issue for the industry. Many a conversation has been had on how best to recruit patients. And that’s all before factoring in how to retain them. Devising an effective strategy for enrollment and retention of patients is crucial to a study’s success. After all, without patients, there’s no study. Therefore, when vetting prospective sites, ensure it has the ability and the resources to recruit and retain patients.
4) The capacity to gather and obtain quality data
The challenges of garnering high quality data in clinical studies has been well-documented in the past. With sites at times working under pressure to provide data, it can be easy for data to be manipulated in order to generate the right results. It’s important therefore that the selected site have experienced data managers with the ability to handle and obtain large streams of data.