During a clinical trial, investigators can provide the most value by providing their attention exclusively to the trial.1 In fact, patients are more likely to enroll in a trial if they think the investigator is focused and enthusiastic.1 However, managerial tasks often prevent investigators from giving patients their full attention, which may cause patients to leave a study. This loss of patients is particularly painful in clinical renal research, as patients in chronic kidney disease (CKD) clinical trials are difficult to retain, especially if they already have burdensome interactions with the health care system.2 In addition, the industry’s general lack of experience working with patients that have kidney disease means trials are often designed in a way that makes it difficult for patients to participate. In fact, only about 2.6% of trials with less than 100 patients tracked on Clinical Trials.gov between 2007 and 2010 were dedicated to nephrology interventions.3
Frenova supports sites that specialize in patients that have renal disease, providing us a unique perspective on how the right site management can help optimize your renal research.
Understand the Unique Needs of Renal Protocol Design in Clinical Research
Patients with CKD, end stage renal disease (ESRD) and adjacent conditions are not the same as other patient populations. Often, their onerous care schedules can make them reluctant to participate in clinical trials.3 When discussing participation, sponsors must assure patients that their needs will be met.
Understanding the needs of renal patients is where Frenova excels. We provide clinical trial consulting to ensure your protocol’s design addresses renal patient concerns before enrollment begins. Our global network includes over 1,300 clinicians with expertise across the renal disease therapeutic area. Their practical knowledge of renal patients can help sponsors optimize protocols to keep studies moving according to a timeline.
Frenova’s informed, patient-centric approach has a strong record of success. For example, our investigators within F1RST UP®, our exclusive alliance of expert renal trial sites, have enrolled twice as many patients compared to other sites.4 We also executed our site management duties during the height of the SARS-CoV-2 pandemic; in one study we provided nine sites and overenrolled patients while only making minor adjustments to the protocol’s timelines.5 We accomplished these feats by preparing for the needs of patients with kidney disease before challenges arose.
Let Your Investigators Do Renal Research, Not Management
Site investigators are scientific and clinical professionals with expertise in executing clinical trials. However, their primary responsibilities are to their own practice and seeing patients for the trial. Sponsors should avoid burdening them with extra paperwork, as they already have incredible demands on their time, and this could lead to errors. Errors have a chance of being incredibly costly for a sponsor, especially if a mistake leads to a protocol amendment, which is estimated to add $500,000 USD in expenses, and adds nearly three months onto a project’s timeline.6
Frenova has found an effective solution: provide clinical trial project management services so investigators do not need to do any managerial work. By outsourcing project management, investigators can focus on working with patients in the study and their practice. This also allows them to focus on care, science and data analysis, without the distraction of budgets, timelines or other business processes.
Investigators are still included in our regular consultative support meetings and receive direct communication about the overall performance of a site, but Frenova’s staff handles the details of the everyday paperwork. All parties benefit from this type of arrangement, including Frenova. When sites empower our project managers, Frenova’s team can use their knowledge and position to foresee upcoming changes and react to them thoughtfully and strategically, without slowing down for bureaucracy. Their guidance can help a study proceed successfully even through unpredictable events like a global pandemic.5
Initiate Faster Clinical Research Site Start-Ups
A faster start-up means a faster trial. On the other hand, a slow site start-up process can effectively place your trial on the wrong foot before the work has truly begun. Investigators may know what adjustments need to be made for kidney patients, but CKD and ESRD patients’ underrepresentation in clinical trials means that many sites do not have the practical experience to properly work with this population.7,8 Knowledge is not enough.
We can transition smoothly from assessing site feasibility to on-the-ground site work, like site activation and study execution. Our renal clinical project management and consulting services come together to accelerate start-up. We provide protocol feasibility assessments, site identification and activation, all informed by years of experience providing high-quality clinical trial site management for CKD and ESRD patients. We know what to expect from these patients.
In addition, as part of our project management’s time-saving initiatives, we provide contract and budget negotiations faster (25 days) than sites outside of our alliance (41 days). With our unique combination of capabilities, our alliance sites activate, on average, 63 days after selection, and enroll patients 52 days later, on average. That sum of 115 days is nearly half of the industry benchmark of 210 days.4
Put It All Together for Better, Faster Clinical Renal Research
Frenova is specifically designed to accelerate renal clinical trials. From before the study begins to start-up, we set our clients up for success by predicting and preparing for the specific needs of renal patients. Our site management staff’s takeover of managerial tasks allows investigators and clinicians to focus on working with patients, which in turn better maintains enrollment, which is the biggest factor in determining trial timelines.9 Finally, our start-up times are better than industry benchmarks, fueled by our unique capabilities in renal clinical trials, contract negations and kidney disease research site selection.
By partnering with a high-quality managed research network partner like Frenova to handle site management, sponsors can optimize their clinical renal research and get better results, faster.
Talk to Frenova about our site management services.
References
1. Fogel D.B. 2018. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemporary clinical trials communications, 11, pp. 156-164.
2. Natale P., Gutman T., Howell M., Dansie K., Hawley C.M., Cho Y., Viecelli A.K., Craig J.C., Jesudason S., Chapman J.R., Johnson D.W., Murphy L., Reidlinger D., Crowe S., Duncanson E., Muthuramalingam S., Scholes-Robertson N., Williamson A., McDonald S., Wong G., Teixeira-Pinto A., Strippoli G.F.M., Tong A. Recruitment and retention in clinical trials in chronic kidney disease: report from national workshops with patients, caregivers and health professionals. Nephrol Dial Transplant. 2020 May 1;35(5):755-764. doi: 10.1093/ndt/gfaa044. PMID: 32240311.
3. Inrig J.K., Califf R.M., Tasneem A. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov. Am J Kidney Dis. 2014;63:771–780.
4. Kurt Mussina and Christina Kahn. F1RST Up®: Accelerating Clinical Trial Start-Up. Frenova Renal Research.
5. (cite Frenova’s upcoming COVID-19 Case Study –in process at time of writing)
6. Getz K. Improving protocol design feasibility. doi:10.3390/ijerph110505069.
7. Charytan D., & Kuntz R.E. The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease. Kidney International, 70, 11, 2021-2030, (2006).
8. Baigent C., Herrington W.G., Coresh J., et al. Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int 92:297-305 (2017). https://kdigo.org/wp-content/uploads/2017/02/KDIGO-Challenges-in-conducting-clinical-trials-in-nephrology.pdf
9. Lamberti M.J., et al. Assessing study start-up practices. doi: 10.1177/2168479017751403.
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