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Expanding Site Selection to Quality Sites Synteract Participates on MAGI Panel on Advancing Site Selection

Expanding Site Selection to Quality Sites Synteract Participates on MAGI Panel on Advancing Site Selection
14 November 2018

Site selection is a critical aspect of successful clinical trials. Sponsors and CROs are often drawn to known sites with which they have strong working relationships and that are good performers and enrollers. However, it’s also important to continually expand the pipeline. Ensuring extra bandwidth and sites is critical when it comes to increasing volume, to get a good mix of hard-to-find community health centers in addition to academic centers, and to account for instances when existing sites might be committed to other, competitive studies. But how can sponsors and CROs determine a quality site if they have never worked with it before?

Synteract’s Laura Deason, Manager, Patient and Site Advocacy, who has been working with sponsors and CROs in coordinating clinical trials for the past 15 years, recently was asked to participate on a Blue Ribbon Sites Round Table Discussion at MAGI West Conference in San Diego, October 21-24 on this very topic. Deason was one of eight panelists participating alongside 15 Blue Ribbon Sites in oncology, endocrinology, women’s health, pediatrics, family practice, and other specialties.

The MAGI Blue Ribbon Sites Program is a fairly new concept. Last year, at its annual conference in San Francisco, MAGI, a voluntary organization focused on advancing clinical research by standardizing best practices for operations, business, and regulatory compliance, announced The MAGI Blue Ribbon Sites Program. The program’s objective is to promote a culture of excellence in clinical research sites. MAGI Blue Ribbon Sites meet the following criteria:

  • Have been conducting clinical research for at least five years
  • Conduct enough clinical research to ensure stability (e.g., have at least two full-time study coordinators)
  • Start studies quickly
  • Have consistently met enrollment commitments in the past year for at least one investigator in at least one therapeutic indication
  • Maintain a substantial database of potential study subjects
  • Accept ethical review by accredited central IRBs, or a local IRB that meets the same standards for timeliness
  • Are a member of at least one selective site network or CRO/sponsor preferred site program (preferred)
  • Have a sterling reputation among study sponsors, CROs and other MAGI Blue Ribbon Sites

Gary Fiocco, CEO of the PCRS Network, LLC, served as the moderator of the panel and Norman Goldfarb, chairman of MAGI, who was instrumental in implementing the program, was also in attendance. The objective was to have attendees walk away with a few solid ideas about improving the process of site feasibility, budget and contract negotiations, developing good working relationships and effective communications among sponsors, CROs, and sites.

Attendees agreed that the process of site selection needs to be improved. Deason noted one thing that was most revealing: The sites stated having one point of contact as a “go to” person with the sponsor or CRO pre-award, as well as during post-award activities would be ideal. Sites want a single point person who would be helpful to complete feasibility questionnaires, follow-up on any changes for data, capabilities, and so on.  

“That is how I view my role as a patient and site advocate in North America. That’s what we do, so this news was encouraging,” says Deason. “I offer myself as the one point of contact for Synteract, as does my counterpart in Europe, Thomas Berger.”

Additionally, Deason says that sites want to be considered a partner with the CRO and sponsor versus a vendor. They were interested in knowing what types of metrics CROs and sponsors use when they consider performance to get included in a preferred site list. Panelists noted that CROs and sponsors assess site metrics, recruitment data, query rates, resolution time/averages, patient drop-out rates, and screen-failure rates. Study start up metrics are maintained as well, but vary depending on how sponsors consider start up – from the date the essential document package is sent to the site or the date of site initiation visit. Sponsors also typically keep scorecards on site performance, including levels of experience of the site and its staff. 

Another question that was posed by a site: Is EMR data important to collect in terms of feasibility and data mining? Panelists agreed that yes, EMR data is very important. However, one must know what codes to look for and how to interpret the information. Standards need to be developed across the board to define capability and quality to consistently report and speak to the numbers. For instance, for sponsors and CROs looking for data on a specific indication, such as a type of leukemia like AML, the code could be captured in the EMR but filed with four different codes for leukemia, making interpretation of the data complex.

A question was posed: Should there be a standardized set of metrics to evaluate site performance? A consistent challenge among CROs and sponsors is where to capture the feedback of site performance. While panelists agreed it would be good practice to report on study startup, education, months to enrollment, and other key statistics, CROs and sponsors also noted a few challenges.  

First, soft indicators are recommended for consideration, such as a site’s awareness of standards of care, knowledge of concomitant medications in the protocol, and other aspects of a particular indication. However, this information is hard to capture on feasibility questionnaires before going into the trial.

Second, how should the industry validate sites’ responses on questionnaires or standardized metrics? How should quality control measure consistency? While sites can claim certain query rates, these statistics need to also be proven and validated by CROs and others.

A committee of sites, sponsors and CROs will follow up to create a standardized library of site scorecard metrics to help everyone understand what high performance and quality look like.

Selecting the best sites to work with is an integral part of study management and design. It is encouraging that important organizations like MAGI are taking a comprehensive look at the industry and what makes for quality sites. We are happy, at Synteract, to be part of this continuing discussion.

For more information on how Synteract brings clinical trials to life, please see this case study as just one example or email melissa.hays@synteract.com for more details. 

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