TY - JOUR
T1 - The evolution of clinical trials in renal cell carcinoma
T2 - A status report for 2013-2016 from the clinicaltrials.gov website
AU - Ghatalia, Pooja
AU - Koenigsberg, Rebecca
AU - Pisarcik, David
AU - Handorf, Elizabeth A.
AU - Geynisman, Daniel M.
AU - Zibelman, Matthew
N1 - Publisher Copyright:
© 2017 - IOS Press and the authors. All rights reserved
PY - 2017
Y1 - 2017
N2 - Background: We previously published an analysis of clinical trials in renal cell carcinoma (RCC) using the publicly available ClinicalTrials.gov registry. Here we present a 3-year update to understand clinical research current trends in RCC compared to 2013. Methods: The Website's advanced search function was used to search for RCC trials. The characteristics of the trial were extracted, summarized and compared to 2013 data using Fisher's exact tests. Results: We locked our search on May 26, 2016 with 165 trials eligible, compared with 169 trials on Sep 25, 2013. There were more phase I and I/II trials in 2016 compared to 2013 (40.8% vs 24.9%, p = 0.05). More clinical trials in 2016 compared to 2013 used immunotherapy (IT) alone or in combination with other drugs (24.2% vs 10.7%, p = 0.001), and the use of targeted therapy alone (TT) declined (32.9% vs 47.9%, p = 0.005). TT+IT combination trials more than doubled (6.7% vs 2.3%, p = 0.07). The number of trials with treatment in (neo)adjuvant settings in 2016 and 2013 were similar (9.7% vs 10.6%, p = 0.77), respectively. Compared to 2013, the number of trials with non-clear cell histology remained low (n = 10). Many more trials were sponsored by the pharmaceutical industry in 2016 vs 2013 (41.5% vs 16.0%, p = <0.001). Conclusion: IT-based and industry sponsored clinical trials significantly increased from 2013 to 2016 with a concomitant drop in TT only trials. The increase in industry-sponsored studies may reflect the rapid uptake of expensive IT drugs. There continues to be a paucity of (neo)adjuvant studies and for non-clear cell histologies.
AB - Background: We previously published an analysis of clinical trials in renal cell carcinoma (RCC) using the publicly available ClinicalTrials.gov registry. Here we present a 3-year update to understand clinical research current trends in RCC compared to 2013. Methods: The Website's advanced search function was used to search for RCC trials. The characteristics of the trial were extracted, summarized and compared to 2013 data using Fisher's exact tests. Results: We locked our search on May 26, 2016 with 165 trials eligible, compared with 169 trials on Sep 25, 2013. There were more phase I and I/II trials in 2016 compared to 2013 (40.8% vs 24.9%, p = 0.05). More clinical trials in 2016 compared to 2013 used immunotherapy (IT) alone or in combination with other drugs (24.2% vs 10.7%, p = 0.001), and the use of targeted therapy alone (TT) declined (32.9% vs 47.9%, p = 0.005). TT+IT combination trials more than doubled (6.7% vs 2.3%, p = 0.07). The number of trials with treatment in (neo)adjuvant settings in 2016 and 2013 were similar (9.7% vs 10.6%, p = 0.77), respectively. Compared to 2013, the number of trials with non-clear cell histology remained low (n = 10). Many more trials were sponsored by the pharmaceutical industry in 2016 vs 2013 (41.5% vs 16.0%, p = <0.001). Conclusion: IT-based and industry sponsored clinical trials significantly increased from 2013 to 2016 with a concomitant drop in TT only trials. The increase in industry-sponsored studies may reflect the rapid uptake of expensive IT drugs. There continues to be a paucity of (neo)adjuvant studies and for non-clear cell histologies.
KW - Adjuvant
KW - Immunotherapy
KW - Kidney cancer
KW - Neoadjuvant
KW - Retrospective
UR - http://www.scopus.com/inward/record.url?scp=85074720600&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000664207200008&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.3233/KCA-170015
DO - 10.3233/KCA-170015
M3 - Article
C2 - 30334017
SN - 2468-4562
VL - 1
SP - 151
EP - 159
JO - Kidney Cancer
JF - Kidney Cancer
IS - 2
ER -