How to get established as a new Clinical Research Site
Before a site can host a clinical trial and recruit patients, there are a series of steps that need to be followed for a clinical research site to get awarded studies. We have listed the very first steps below:
Finding your new Principal Investigator (PI). Brand new sites struggle with recruiting a PI to get established as a clinical research site. There are many ways to find new PIs, including contacting local practices or utilizing past relationships. One trend we have seen is the use of retired physicians. This may sound unorthodox, but there’s a large time commitment required for clinical research and with a retired PI, you get the experience and time commitment needed. Since most retired PIs may not have a large patient population anymore, it is recommended that you get a sub-investigator who has a large private practice. That way your site will have access to both a large patient population and a PI with extensive experience [1].
Search for studies or join a network. Once you have a PI in place, you will need to find studies for your site to work on! ClinicalTrials.Gov is typically a source used by patients to find clinical
trials for their own care. However, sites can also search ClinicalTrials.Gov for studies that are upcoming and either work with a CRO or connect with the Sponsor directly to potentially “land the study” at their facility. Sites can also go to meetings or conferences in their fields of interest to meet CROs and Sponsors face to face. [3]. Additionally, it may be helpful for your site to join a network that will act as an extension of your site to help match you with studies through established partnerships with CROs and Sponsors.
Preparing for the CRA pre-study visit. Once a Sponsor is interested in evaluating your site for a potential study, it is time to prepare for your pre-study visit. Getting a site up and running for a study is expensive for the Sponsor and it’s up to the CRA to see if your site is a suitable candidate. Staff experience, necessary equipment, and excitement for the study are just a few of the requirements for a “successful” study location according to the Sponsor. CRAs will also look for any active studies nearby that would compete for the patient pool needed, as that may hinder enrollment at your site [4]. There will always sites that don’t do as well as the others, but the CRA pre-study visit is set in place to weed those out.
Did you find this article helpful?
Source:
- http://www.TheClinicalTrials.guru
- https://www.dcri.org/trial-participation/KeysBuildingSuccessfulResearchSite.pdf
- https://www.apcrnet.org/sites/default/files/Ross_18.pdf
- http://clinopstoolkit.com/2008/01/pre-study-visits-and-site-initiation-visits.html
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About BTC Network
BTC Network is North America’s leading clinical research group. Based just outside of Boston, Massachusetts, our network includes more than 50 multi-therapeutic sites. All BTC research sites collaborate with or are part of private practices, giving us access to over 100,000 patients.
