Chronic Renal Failure
This study of an intravenous alternative in chronic renal failure (CRF) patients was challenged by a patient population that was difficult to qualify and maintain. PAREXEL’s global network of sites, innovative management practices, and industry-leading clinical technology helped complete the study on time despite multiple clinical and cultural challenges. PAREXEL’s comprehensive range of services for these studies included trial design and management, clinical logistics, and integrated eClinical technologies.
Chronic renal failure, a consequence of chronic kidney disease, trauma, immune disorder, and certain other conditions, is a growing public health concern worldwide. Often causing high health care costs but yielding poor outcomes, kidney disease is the ninth leading cause of death in the United States, and is growing in incidence in other industrialized nations.
Key challenges and solutions
- Strategic country and site selection — The saturated clinical trial environment in Western Europe, competitive environment for similar therapies, and patent protections made trials in most of the European countries impossible, or impractical at best. PAREXEL conducted feasibilitystudies in countries without patent protection and used key site relationships to establish a site network in Eastern Europe and Latin America, including Bosnia and Serbia., a first for PAREXEL. Also, conducting more than one protocol in many of the trial facilities allowed for greater patients enrollment per site.
- Patient and investigator qualification — Because EPO wasn’t reimbursed in the trial countries, pre-dialysis patients were difficult to recruit and the maintenance population was hard to find. In addition, many sites had previously failed to identify patients’ needs for iron treatments, further limiting the availability of qualified trial candidates. These pretreatment assessments resulted in low patient forecasts. In order to recruit enough patients who met study criteria, PAREXEL implemented a patient- prescreening system that reduced a potentially high screening failure rate, including an ICF that established candidates’ ferritin levels. Calls with KOLs aided study design. PAREXEL also implemented an incentive schedule that improved the prescreening evaluation (to yield betterqualifiedscreening candidates) and bolstered both investigator and patient compliance over the course of the trial.
- Centralized program leadership — PAREXEL achieved maximum efficiency by assigning program management to one Program Director, two Program Managers and a complete complement of Functional Department Leadsoverseeing all six protocols.
- Technology-enabled real-time metrics — Integrated eClinical technologies, including Perceptive Portal™, by PerceptiveInformatics, a PAREXEL company, allowed study personnel and the management team to retrieve and combine data from multiple sources to answer key questions about the trials, and to intervene quickly when problems arose. Online study forums and announcements enabled investigators to publish and access relevant study materials, communicate with other investigators, and share best practices. Close monitoring of central lab activity also helped keep measurement practices calibrated across sites.
- Clinical trial material logistics management — Effective distribution of drug and related trial material was critical to success. The study procedures were logistically challenging because of the patient quality requirements, high frequency of patient visits, multiple materials vendors, and a virtual central laboratory involving partner labs. In response, PAREXEL designed an innovative clinical trial materials logistics program that assured materials arrived at alllocations to correct and complete specification.
PAREXEL’s strategic study design, careful program management, and up-to-the-minute trial data intelligence helped the sponsor complete their study on time despite many challenges in recruiting and retaining high quality patients and investigators. By working closely together and with the sponsor, the PAREXEL trial management team was able to proactively identify opportunities to improve trial performance and to overcome obstacles as they appeared. And by performing the role of clinical trial supply manager, PAREXEL was able to achieve a global presence: central coordination of international sites each with local oversight. Combined with powerful Perceptive technologies, such as IVRS and Perceptive Portal, PAREXEL practices and capabilities resulted in timely enrollment completion and database locks. PAREXEL continues an ongoing strategic relationship with the pharmaceutical sponsor.
- Study design: Multinational, multicentre, randomized, controlled, double-blind, comparative, parallel group Phase III studies.
- Key criteria: Patients must have been on a minimum of 3 months of stable therapy prior to enrollment into the study. Blood values for Hb and Ferritin required for study entry were assessed in pre-study testing at the central lab.
- 6 studies in total: 2 in correction phase, 2 in maintenance, and 2 follow-up studies.
- 351 patients enrolled, 270 randomized
- 34 active sites
- Eastern Europe: Bulgaria,Croatia, Poland, Turkey, Israel
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.