Frenova, the only phase I-IV drug and device clinical development services provider dedicated exclusively to renal research, is launching an alliance to accelerate clinical study startup. Named F1RST Up, for Frenova Rapid STart Up, the exclusive alliance connects physicians with recognized as leaders in nephrology research. The purpose of the alliance is to remove the administrative and contract obstacles that often impede clinical trials.
Based in Massachusetts, Frenova maintains the world’s largest network of renal resources, including more than 200 principal investigators and 250 dialysis research sites. Frenova also provides access to more than 183,000 active end-stage renal disease patients and 390,000 active chronic kidney disease patients.
The clinical research sites included in F1RST Up were carefully culled from Frenova’s network. As large, high-performing research sites, they have a proven track record of successful research in vascular access and care, cardiorenal conditions, chronic kidney disease, end-stage renal disease, cardiovascular disease, rare diseases, infectious diseases and transplant.
Kurt Mussina, Frenova vice president and general manager, said, “F1RST Up provides an opportunity for principal investigators and research coordinators to be more involved with everything from protocol design to budgets to study execution. The goal is to ensure that all parties are in an optimal position for success right from the start. By combining F1RST Up with our dedicated study startup team, we are able to begin recruiting patients as soon as we’re given the greenlight. F1RST Up also improves Frenova’s access to additional patients who are not on dialysis.”
Mussina explained, “Every trial in the pipeline—from pre-dialysis and end-stage renal disease studies to cardiorenal and cardiovascular studies—will benefit from F1RST Up. Because F1RST Up connects trial sponsors to a highly select group of high-performing sites and investigators, trials will be able to get underway more quickly. Sponsors also have more ready access to thought leadership in these areas, which will help them better reach successful outcomes.”
In addition, Frenova is currently user-testing other concepts with investigators that will complement F1RST Up.
Others recognize the move as good for the industry. Mario Boskis, CEO and founder of Activa Cro, said, “Providing a sponsor with a streamlined site contracting process is a great initiative on the part of Frenova. In our business, time is a commodity that can’t be badly spent. Having a robust initiation process set up in advance, even before a clinical trial is presented to a site, will positively impact the timeline from contract award to recruitment of the first patient.”
Boskis went on to say, “At Activa, although we do not have an approach similar to the F1RST Up initiative, we do tend to perform feasibility activities in sites that have proven to be efficient in contract negotiation and execution. Of course quality and expertise should always be a given, but administrative issues are not always taken into consideration when selecting sites, and this can be a real hurdle to a successful study startup.”
Maria Fotiu, vice president of Global Clinical Development, head of the Site Intelligence and Activation (SIA) group at PPD, reported seeing a desire to reduce administrative burden on clinical sites, making it easier to conduct studies and freeing them to focus more fully on patients.
Fotiu said, “From PPD’s perspective, the number one goal of SIA and ultimately our strategic site collaborations group is to look for ways to improve the overall experience and to develop site relationships. We are trying to incorporate not only patient feedback, but also site feedback into the process. We view that as the best opportunity to improve the overall experience.”
Last year, PPD established a pediatric investigator network to better respond to the needs of its customers and sites. The network’s primary goal is to support early engagement in the clinical trial space by introducing the investigator perspective into the protocol design and optimization activity.
“Ultimately, at PPD we want to deliver quality clinical trials, and pediatrics was one of the spaces where we felt there was an unmet need,” Fotiu said. “Our biopharma partners have seen an increased need to deliver on their pediatric trials. Positioning ourselves with our site relationships with our pediatric investigators was really important to us.”
Another group at PPD focuses entirely on strategic site collaborations, building relationships with sites and networks, SMOs, universities and health networks to see how to improve the experience not only for the site itself, but also for the patients and the sponsors working with those networks.
The PPD Select program comprises their broader network of sites with whom they work to expedite study startup. Said Fotiu, “We are finding ways to reduce the time for contracting, budgeting, confidentiality disclosures and also streamlining the feasibility process. It allows us to put a relationship manager in place who works with the site throughout their trial participation and is constantly providing feedback to the sponsor to help the process go quickly.”
Other companies are not only working to target similar opportunities, but also prove their benefit. Steve Galen, vice president of Clinical Operations at PRA Health Sciences, said, “At PRA Health Sciences, we certainly are interested in working with sites and site alliances to make the site startup process faster and more efficient. Faster study startup means study enrollment starts, and finishes, earlier. It is encouraging to see process mapping and process reengineering of the study startup process occurring in many places across the industry. Demonstrating quantitative reductions in startup cycle times with respect to baseline measures will definitively demonstrate the value of this approach.”
Frenova’s F1Rst Up is almost certainly a positive impact on renal trials. The industry recognizes and supports the move, while finding other innovative ways to speed clinical trial study startup.
Lisa Chontos is a freelance medical writer with 15 years of experience writing for hospitals, biotech firms, pharmaceutical companies and publications like CenterWatch. You can contact her at firstname.lastname@example.org.
This article was reprinted from Volume 20, Issue 07, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »