An overarching theme of the virtual conference was that a key to successful patient recruitment to clinical trials is the recruitment and selection of participating investigators and sites.
CROs are perhaps in a unique position to assist in the assessment and enlistment of the facilities and infrastructure associated with a trial site, especially for pharma and biotech companies not intimately familiar with regulatory requirements, local customs, and demographics.
Many CROs specializing in navigating the clinical trial landscape may even have pre-established relationships with institutions amenable to hosting clinical trials.
With Scimega’s “Reverse Feasibility” program, for example, the CRO engages in ongoing dialog with a network of oncology investigators to identify their study needs. Sites can thus be prequalified, contractual provisions prevetted, and confidentiality agreements set in place.
“This allows us to match studies to sites that are motivated to recruit patients and get trials up and running as soon as possible,” Lara said.
Oncology trials are a little bit different from other trials—in aspects ranging from the complexity and regulations surrounding procedures, to how sick the patients may be, to physicians’ motivation for being involved—said Tom Ruane, senior director, patient recruitment, Quintiles.
He sees a need for collaboration not just with pharma but also with the investigators running studies at the site level “to get an understanding from their perspective before we just send out studies to be done.”
And while pre-eminent sites with key opinion leaders are highly regarded in the industry, they may not see everyday patients in everyday settings. So Quintiles tries to complement high-profile centers with smaller district hospitals that may have less opportunity to take part in clinical trials.
Especially when dealing with non-Western sites, a host of other considerations come in to play as well, and sponsors should not assume that every willing site is actually able to conduct a given clinical trial. Many may need added assistance when it comes to following protocol, for example, and in differentiating between medical practice and clinical research, Gargano said.
Novotech—which operates in eight countries across the Asia-Pacific region—has developed a profile that it looks for in the ideal target site, and uses a comprehensive questionnaire to assess a site’s capabilities in terms of recruitment potential, experience, interest in a trial, and understanding of the protocol.
Potential competing trials, previous experience in conducting trials, and investigator commitments should also be looked at.