Augmenting the randomized controlled trial with real-world data to aid clinical decision making in metastatic renal cell carcinoma: a systematic review and meta-analysis

• Published in: Future oncology (London, England) Vol. 15; no. 34; pp. 3987 - 4001
• Main Authors: Moran, Michael, Nickens, Dana, Adcock, Katherine, Bennetts, Meg, Charnley, Natalie, Fife, Kate
• Format: Journal Article
• Language: English
• Published: England Future Medicine Ltd 01.12.2019
• Subjects: Carcinoma, Renal Cell - drug therapy; Carcinoma, Renal Cell - mortality; Carcinoma, Renal Cell - pathology; Clinical Decision-Making - methods; clinical trials; Evidence-Based Medicine - methods; Evidence-Based Medicine - trends; Humans; Kidney Neoplasms - drug therapy; Kidney Neoplasms - mortality; Kidney Neoplasms - pathology; Medical Oncology - methods; Medical Oncology - trends; Progression-Free Survival; Protein Kinase Inhibitors - pharmacology; Protein Kinase Inhibitors - therapeutic use; Protein-Tyrosine Kinases - antagonists & inhibitors; Protein-Tyrosine Kinases - metabolism; Randomized Controlled Trials as Topic; real-world data; renal cell carcinoma; tyrosine kinase inhibitor; renal cell carcinoma; clinical trials; real-world data; tyrosine kinase inhibitor
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2019-0421

To evaluate how efficacy outcomes from real-world data (RWD) can support those from randomized controlled trials (RCTs), in the context of first-line tyrosine kinase inhibitor treatment of metastatic renal cell carcinoma. PubMed, Ovid, MEDLINE and EMBASE were searched for RCTs and RWD studies with ≥50 adult patients per arm published in 2000–2017. Outcome measures were median progression-free survival, median overall survival and objective response rate. A total of 13 RCTs and 22 RWD studies met eligibility criteria; 31, 28 and 25 studies, respectively, reported median progression-free survival, median overall survival and objective response rate. Summary outcome measures were similar in RWD and RCTs. RWD validates efficacy-based outcomes from RCTs and may provide supportive evidence to inform clinical decisions.