Corinne Williams, MS, CCRP, Senior Project Manager; and Tim Breen, Ph.D., M.S., CCDM, Director, Clinical Research Informatics, Hoosier Oncology Group
Success of multi-site clinical trials depends on timely accruals and timely accruals depend on quality research centers. Selection of quality research centers is an essential component of the successful management of multi-center trials. The quality “go-to” research center or site has specific characteristics that CROs or Pharma look for during site selection. The site-selection process begins with the determination of the number and type of sites required for the clinical trial. The complexity of some clinical trials may demand academic institutions only, while other trials would be appropriate for a mixture of community and academic institutions. The consequences of choosing too few sites, the wrong type of sites or poor quality sites will be clinical trials that take too long to accrue or fail.
Common Site-Selection Methods by CROs and Pharma Companies
Site selection is a multi-factorial process. The disease population, eligibility criteria, treatment requirements and outcome evaluation are among the basic characteristics to consider when evaluating sites. Expert input from PIs and other clinical research professionals can also be helpful in the decision to choose a particular site or for referrals for potential sites. One of the most effective methods to evaluate sites is the site feasibility survey. These surveys can provide information on accrual potential, regulatory timelines and site capabilities essential to the success of a clinical trial. Also, historical performance can be used to generate lists of potential sites. Finally, analysis of accumulated site data gives an objective evaluation of site performance. For example, the correlation of accrual estimates from site feasibility surveys and actual accrual can determine which sites report reliable feasibility data.
What are the characteristics that a site can cultivate to make it a “go-to” research site?
Communication is at the top of the list of quality sites. Responsiveness to requests for information including site feasibility surveys and screening logs indicates a site’s willingness to fully participate in a multi-center clinical trial. Principal investigator engagement is also very important. Sites that accrue and respond to clinical trial requirements have interested and engaged principal investigators. The quality of site research coordinators is crucial to the successful participation of a site in a multi-center clinical trial. Sites that meet their commitments will always be valued over sites that are less reliable. These are some of the characteristics that a site can cultivate to rank at the top of the site-selection list.
The Hoosier Oncology Group (HOG) is a not-for-profit oncology research organization established as a collaboration between academia and community oncology practices. Since its creation in 1984, the HOG has conducted more than 150 studies, enrolling more than 3000 patients across more than 200 research sites. The HOG offers a full spectrum of oncology research services including protocol development, clinical trial management, data management, analysis and manuscript preparation. In addition, the HOG has a Biorepository with a full set of services for correlative laboratory studies. Currently, there are 10 active clinical trials, accruing from more than 106 unique research sites.
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