Cancer drug development is perhaps the most arduous task faced by the drug industry today with technically difficult, time-consuming, and expensive clinical trials constituting the lion’s share of that challenge.
Merely handling the logistics of the trials—how and where they should be conducted, recruiting patients, and monitoring the sites—can be daunting for cost-sensitive pharmas, which is why more and more turn to contract research organizations with oncology expertise to help tap the lucrative cancer therapeutics market.
Researchers from several of these CROs shared their thoughts at “Oncology Trials Outsourcing”, a virtual conference hosted by Outsourcing-Pharma.com.
Oncology clinical trials increasingly require the assessment of biomarkers, molecular and genetic profiles, and complex pharmacokinetics, often involving the services of a central laboratory, pointed out Julie Gargano, therapeutic area director, oncology, for Novotech.
The total number of unique procedures performed per protocol has increased by more than one-third in the past decade, said Roberto Lara, manager, business development for Scimega Research. This, in turn, has led to a huge rise in the administrative burden sites are saddled with.
At the same time the total number of trials being conducted is increasing—there are nearly 10,000 oncology compounds under evaluation, more than half of which are being tested in patients—and many sites in the West are becoming saturated. The result has been poor recruitment and extended study timelines.
“It’s no secret that patent life is an issue,” observed Lara. “The faster we become at concluding our trials, the more we’ll be able to maximize our return on investment.”
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.