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For a clinical trial to be successful, different key aspects must be carefully met and this includes selecting a trial site. The chosen site can delay or speed up the trial depending on the available infrastructure and the research teams you work with. The staff, for instance, will be responsible for enrolling, treating, and evaluating the trial participants. Caution and professionalism must be employed when selecting a potential trial to avoid such. Do not just rely on online-based patient information; conduct a physical site inspection to validate the authenticity of the stated features and work with a credible CRO such as Veristat to streamline the process. That said, in this post, we’ll look at how to select a trial site and the criteria to consider.
Staff Experience
As you evaluate a site, consider the available staff. They should be well-trained and experienced to handle clinical trials. The clinical trial planning should include a staff verification checklist that will ensure they have an understanding of the clinical protocol, compliance procedures, and submissions to ethical and regulatory authorities. Also, staff should ensure they get patients’ informed consent and study processes among other things. The dangers of working with inexperienced staff stretch wide that’s why a thorough check should always be done on available site staff.
Site Capabilities
A trial inspection can help ascertain that the site is well equipped to handle the clinical trial. The available equipment and infrastructure should also be checked; though available, the appliance might not be in their best years, which can delay and use up trial resources.
Pre-registered Patients
A site with already registered patients is an even better choice. Such a site could save money by reducing the expense of recruiting new participants. However, it is critical to ensure that the site isn’t currently doing a similar trial, as this might result in undesirable competition.
Location
Financial constraints often caused by frequent site visits are a major reason for patient drop-out. As such, during site selection, trial organizers must choose sites that are conveniently located. in doing so, they’ll reduce the financial burden on patients. The site location will also impact the patient recruitment process and help meet the desired enrollment targets, which will, in turn, affect the trials timeline.
Timing
Timing also matters, not just for the trial run-down but also for the time to finalize the trial protocol synopsis. Selecting a site without the synopsis will be futile as it is hard to meet unknown standards. But, when the protocols are done before the site selection, they act as a guide and checklist.
CROs
Finally, collaborating with an experienced CRO’s network can efficiently identify viable sites. Sponsors must be willing to let go of the old when it isn’t working and embrace the new to improve the overall trial experience and outcome. This means they must learn to do away with poor-performing sites and consider working with a site they have not previously worked with. Additionally, they must use a rigorous site selection process, verify a trial for what it claims to be, and have, including its past achievements and current features, to ensure that patients receive the best care.
The site you choose will impact your trial overall timeline, patient recruitment and retention, and the overall results. As such, the selection process should be rigorous and professional.
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