Abstract: FR-PO1199
Clinical Trials in Nephrology: An Updated Systematic Review of ClinicalTrials.gov
Session Information
- Transplantation: Clinical - Immunosuppression, Adherence, Outcomes
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 1902 Transplantation: Clinical
Authors
- Mustafa, Reem, University of Kansas, Kansas City, Kansas, United States
- Husainat, Nedaa, University of Kansas, Kansas City, Kansas, United States
- Kalot, Mohamad A., University of Kansas, Kansas City, Kansas, United States
- El alayli, Abdallah, Lebanese American University, Beirut, Lebanon
- Shaaban, Adnan, University of Minnesota, St. Paul, Minnesota, United States
- Numan, Laith, University of Missouri, Kansas City, Missouri, United States
- Alkhatib, Mohammed N., University of Kansas, Kansas City, Kansas, United States
- Sekercioglu, Nigar, McMaster University, Hamilton, Ontario, Canada
- Nizamuddin, Raabia, University of Kansas, Kansas City, Kansas, United States
- Ishida, Julie H., Gilead Sciences, San Francisco, California, United States
- West, Melissa, American Society of Nephrology, Washington, District of Columbia, United States
- Tibbs, Sheri, Duke University, Durham, North Carolina, United States
- Patel, Uptal D., Gilead Sciences, Inc., Foster City, California, United States
- Inrig, Jula K., IQVIA; UC Irvine; Duke University, Yorba Linda, California, United States
Background
Previously published reviews have highlighted low rates and poor quality of clinical trials in nephrology compared to other specialties. In this review, we assessed temporal trends in the quantity and quality of nephrology trials.
Methods
We conducted a systematic review among nephrology trials registered on ClinicalTrials.gov from inception to November 2018. Two independent reviewers assessed every trial and extracted data.
Results
A database of 288,515 registered interventional trials was restricted to studies that included one of 154 nephrology terms. We screened 5412 studies and included 4943 in the analysis. Figure 1 summarizes the number of registered nephrology trials over time. Trials were grouped into 3 Eras [Table 1]. Compared to Era 1, Era 3 had more randomized, blinded, and large trials. Fewer studies were NIH and industry-funded. Drug trials decreased while device and behavioral interventions increased. While there was a decrease in transplant trials, there was an increase in living donor recipient and in glomerular disease trials.
Conclusion
There has been an increase in the number of nephrology trials conducted over time with some improvement in quality and an increase in trials for devices, behavioral interventions, and rare kidney diseases.
| Table 1 | Era 1: 09/30/1982 - 08/31/2010 | Era 2: 09/01/2010 - 08/31/2014 | Era 3: 09/01/2014 - 11/31/2018 |
| Randomization | 77.4% | 84.5% | 82.6% |
| Blinding | 30.3% | 34.1% | 34.7% |
| > 1000 Patient Enrollment | 1.5% | 2% | 4.1% |
| NIH Funded | 8% | 4.5% | 6.6% |
| Industry Funded | 45.3% | 42.8% | 32.2% |
| Drug Intervention | 73.5% | 64.5% | 57.2% |
| Device Intervention | 6% | 8.9% | 10.7% |
| Behavioral Intervention | 2.7% | 4% | 6.2% |
| Glomerular Disease | 5.8% | 6% | 7.5% |
| Renal Transplant (living donor recipient out of all renal transplant trials | 12.7% (11.4%) | 11.6% (8.6%) | 8.1% (23.4%) |