Resolving 3 of the Most Common Hurdles to Clinical Study Acceleration

Despite the best efforts of talented researchers and physicians, clinical trials can be expensive and time-consuming. Working with multiple sites creates a patchwork of contracts, which can lead to cost overruns. Different staff, review boards and expertise at different locations, and dealing with protocol amendments present a range of unforeseeable challenges. In fact, a study from The Tufts Center for the Study of Drug Development (CSDD) showed that nearly every protocol introduced eventually has at least one amendment.¹

No. 1. Enrollment

Patient enrollment usually accounts for between 35 to 50% of a trial’s timeline.² This is one of the most difficult clinical trial bottlenecks to overcome, with some trials doubling their timelines to accommodate poor recruitment numbers. Clearly, any advantage in recruiting patients to a site can save both time and money. Frenova has the experience and expertise to help sites effectively enroll patients with kidney disease. Our practical knowledge allows us to cut through red tape that would otherwise prevent efficient enrollment. The result is a cost-effective timeline for your nephrology study.

In addition, our exclusive partnership with Fresenius Medical Care and our alliance with hundreds of sites gives us access to nearly 4,300 clinics (3,000 in the U.S. and 1,300 in ROW) — which allows us to reach nearly 300,000 end stage renal disease (ESRD) patients and hundreds of thousands of chronic kidney disease (CKD) patients worldwide. In fact, our F1RST Up^® alliance sites in the U.S. often enroll twice as many patients as non-alliance sites.³

Our F1RST Up investigators are often the highest-enrolling sites among all global sites participating in a clinical trial.³ This enrollment creates a positive feedback loop where our physicians develop a deep subject matter expertise in a therapeutic area as they become leaders in that specific space. We create strong investigator-sponsor relationships to capitalize on this expertise.

No. 2. Contracts and Negotiations

Study startup is an ongoing bottleneck in the industry. Site selection and activation are persistent barriers to clinical research. There is no standard process for site identification and it can often take months to complete.

As a part of site selection, there are a number of agreements to negotiate and execute, as well as information to collect. The labyrinth of paperwork surrounding any given clinical trial is massive. Contracting with different entities magnifies this issue, increasing the pressure on overextended principal investigators.

We considered these problems with startup and created a solution for CKD research.

Frenova offers its services across its global network of trial sites. Our network houses the premier locations for your renal research. When you are looking for the best renal intelligence to find sites, patients and data for your next trial, Frenova knows how to provide what you need.

Within the network we offer F1RST Up, a rapid startup solution. A one-stop shop when working with sites, F1RST Up allows sponsors to work with one company. F1RST Up contains an alliance of clinical trial sites dedicated to renal research, including physicians and thought leaders.

Historically, F1RST Up sites averaged 25 days to approve budgets and clinical trial agreement terms compared to the industry benchmark of 57 days.³

F1RST Up standardizes contracting for industry-sponsored clinical trials. We also track each site’s mandatory terms and previously negotiated language in detail so that we can quickly move to study-specific negations.

No. 3. Approvals and Amendments

We know how difficult it can be to have multi-institution IRBs reach a consensus. Contradictory guidance, delayed timelines and unclear reviews can frustrate even the most seasoned investigator. Eventually, you are forced to incorporate costly amendments into your protocols.

However, Frenova can help you mitigate these bottlenecks. By using our sites, you gain access to a centralized IRB for all of our sites. This helps you avoid contradictory instructions and unexpected delays from multiple institution’s IRBs. Among clinical research professionals, this is one of the highest rated process enhancements, with 94.5% ranking it as a top concern.²

One of the primary benefits of the central IRB is preventing costly amendments. In this regard, we can offer our expertise: Frenova knows renal patients. We have successfully conducted numerous studies with CKD and ESRD patients. Beyond helping you attain the approvals for your protocols efficiently, we deliver our industry-leading knowledge on how to run trials with patients who have renal disease. Frenova staff anticipate the disease-specific needs of CKD trials, preventing expensive amendments to your protocols.

Almost all trials require at least one amendment, resulting in about seven changes to the original design. According to the CSDD study, about 37% of these amendments could have been prevented in the design stage with the appropriate practical expertise.¹ On average, just one amendment costs an extra $500,000 and adds nearly three months to your timeline.⁴

Frenova’s experienced on-the-ground staff provides guidance that helps avoid the pitfalls of a new CKD/ESRD trial. We have both physicians and nephrologists on staff familiar with kidney disease clinical trials. Our M.D.s provide insights during study design that can facilitate a better, more effective trial for both patients and your sites.

In fact, our site management solutions focus on supporting patient-centric and site-centric protocols, which historically provide better results and prevent the most common problems CKD investigators encounter. We are here to save you time, effort and money, but most importantly, to make sure your research is expertly performed.

Our investigator-sponsor relationships are a unique advantage that make your clinical trials more efficient, which in turn helps you reach product launch and commercialization that much faster.

F1RST Up facilitates your experience through the major bottlenecks in clinical design: contracts, approvals and amendments.

Frenova Renal Research prevents problems before they develop. Frenova can give sponsors a single, expert point-of-contact to manage renal-related studies. With our unparalleled insight into renal disease and patient care, we are the trusted patient-centric authority for developing study protocols involving renal patients. Our mindful protocol design support eases study execution, boosts operational efficiency, improves patient adherence and helps you avoid costly, time-consuming protocol revisions. To learn how Frenova can accelerate your research,

TALK TO OUR EXPERTS

References:

¹Henry G. Grabowski and Ronald W. Hansen. Cost of Developing a New Drug. Tufts Center for the Study of Drug Development. Tufts University. November 18, 2014.
²Lamberti et al. Assessing study start-up practices. doi: 10.1177/2168479017751403.
³Kurt Mussina and Christina Kahn. F1RST Up^®: Accelerating Clinical Trial Start-Up. Frenova Renal Research.
⁴Getz K. Improving protocol design feasibility. doi:10.3390/ijerph110505069.

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