Site selection for clinical trials: a 2020 guide
Estimates suggest that recruitment difficulties make up about 45% of study delays every year. While these issues are down to a variety of factors, including a stigmatization of - and general disinterest in - clinical research, CROs and clinical trial sponsors look for research sites who can prove that they can successfully enroll, treat and evaluate participants. Careful consideration is essential for several ethical and operational reasons, and so research sites must take care in comprising clinical protocol that fits the needs of their investors.
Sites considered ‘inadequate’ by clinical trial sponsors could ultimately drain valuable resources through the extra training and the costs incurred by delays. In order to prevent these effects, trial organizers must ensure that potential sites are carefully screened and only those which are equipped and able to recruit patients and collect accurate, high-quality data are eventually selected. This will increase the likelihood of a trial that is both timely and cost-effective.
Today, we are giving investors and clinical research recruiters a brief guide on what to look for in research sites; and what research sites should be doing to make sure they impress. Check out our 2020 guide below.
What investors are looking for?
Most clinical research recruiters are well aware of the dangers of choosing wrongly, but simply do not know what they should look for when evaluating potential research sites. Here are some of the essential criteria to consider:
To ensure clinical protocol compliance, it’s important to be sure that the right staff are available at each site. They should be experienced enough to be familiar with necessary compliance procedures, study conduct and clinical protocol. They should also be familiar with trial procedures such as the informed consent process, submissions to ethical and regulatory authorities and contracting.
The screening of potential sites should always begin with a review of the site’s history. The only way to truly be sure the site can meet the requirements of the trial is to ensure it has previously been involved in a study of a similar size or complexity. Recruitment statistics for previous trials, if available, are also a great indicator of expected performance and should be compared to the estimates the site has provided.
Any thorough pre-screening of potential research sites should ensure that the site is equipped to fulfill all the activities specified in the clinical protocol. It is also important to determine whether they currently possess all the necessary infrastructure themselves or if some equipment needs to be provided. In this case, extra costs may be incurred, and delays will be caused.
If a site already has registered patients who meet the study criteria, this could be a significant benefit when it comes to meeting enrollment targets. However, it’s also important to ensure the site is not already involved in other similar studies which may compete for its patients and resources.
If a site specializes in a specific, target disease, they are more likely to be successful in recruiting patients and following protocol.
Travel is often a significant burden on patient recruitment and retention, and a barrier to patient participation. It is important to select research sites that are as close as possible to the target population, in order to achieve desired targets for enrollment and retention. This is especially crucial for those studies that require frequent site visits.
Something to think about
It is important for the design of the study and the protocol synopsis to be clear and finalized before the final selection is made. This ensures that site selection can be tailored to the demands of the study, and an appropriate selection can be made.
Utilising a CRO's network, experience and expertise can undoubtedly help in finding suitable sites and also improve the efficiency of the whole selection process.
Patient recruitment dashboards:
For research sites on a strict budget, the last thing sponsors want to do is waste time and money trying out various modes of recruitment and retention that just don’t stick. It’s a safe enough bet, for phase 1 clinical trials, to rely on traditional methods of recruitment (such as local clinic databases); but the fact is that these methods just don’t stand up in later stages of research. Today, clinical research recruiters should be looking to build relationships with a variety of patients from a wide-scale of geographical locations to ensure compliance in later trials; and the best way to do this is via established patient recruitment portals like Citrus.
Here at Citruslabs, we've created Citrus, the ideal fully-integrated patient recruitment and retention platform, to help any researcher: improve their current enrollment metrics with less effort, drive deeper communication, and boost effective retention that works.
Clinical trial enrollment is notoriously difficult; this is why, every year, 15-20% of research sites fail to enroll a single patient! As most sites now realise, the key to improving these fragile statistics is by implementing a patient-centric approach to clinical research. A patient recruitment dashboard is your all-in-one solution to tackling this industry-wide issue by keeping the focus of your clinical studies on the patient.
Further, we ensure research sites are connected to a thoroughly educated and engaged pool of participants with over 3 million patients on record; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use platform is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment and retention starts here.
Still a little unsure? Check out what our customers have to say about us here.