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. 2022 Mar 1;5(3):e223687.
doi: 10.1001/jamanetworkopen.2022.3687.

Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation

Angela K Green  1   2 , Sara M Tabatabai  2 , Xing Bai  2 , Akriti Mishra Meza  2 , Anne-Marie Lesny  3 , Carol Aghajanian  1 , Ola Landgren  4 , Gregory J Riely  1 , Paul Sabbatini  1 , Andrew Salner  5 , Scott Lipkin  6 , Andrew Ip  7   8 , Peter B Bach  2 , Colin B Begg  2 , Sham Mailankody  1 , Allison Lipitz-Snyderman  2
Affiliations

Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation

Angela K Green et al. JAMA Netw Open. .

Abstract

Importance: The Centers for Medicare & Medicaid Services requires health care organizations to report the National Clinical Trial (NCT) identifier on claims for items and services related to clinical trials that qualify for coverage. This same NCT identifier is used to identify clinical trials in the ClinicalTrials.gov registry. If linked, this information could facilitate population-based analyses of clinical trial participation and outcomes.

Objective: To evaluate the validity of a linkage between fee-for-service (FFS) Medicare claims and ClinicalTrials.gov through the NCT identifier for patients with cancer enrolled in clinical trials.

Design, setting, and participants: This cohort study included 2 complementary retrospective analyses for a validation assessment. First, billing data from 3 health care institutions were used to estimate the missingness of the NCT identifier in claims by calculating the proportion of known participants in cancer clinical trials with no NCT identifier on any submitted Medicare claims. Second, the Surveillance Epidemiology and End Results-Medicare data set, which includes a subset of all FFS Medicare beneficiaries for whom health insurance claims are linked with cancer registry data, was used to identify adult patients diagnosed with cancer between 2006 and 2015 with an NCT identifier in claims corresponding to an interventional cancer clinical trial. To estimate the accuracy of the NCT identifier when present, the proportion of NCT identifiers that corresponded to trials that were aligned with the patients' known primary or secondary diagnoses was calculated. Data were analyzed from March 2020 to March 2021.

Exposures: An NCT identifier present in Medicare claims.

Main outcomes and measures: The main outcome was participating in a clinical trial relevant to patient's cancer diagnosis.

Results: A total of 1 171 816 patients were included in analyses. Across the 3 participating institutions, there were 5061 Medicare patients enrolled in a clinical trial, including 3797 patients (75.0%) with an NCT identifier on at least 1 billing claim that matched the clinical trial on which the patient was participating. Among 1 171 816 SEER-Medicare patients, 29 138 patients (2.5%) had at least 1 claim with a value entered in the NCT identifier field corresponding to 32 950 unique patient-NCT identifier pairs. There were 26 694 pairs (81.0%) with an NCT identifier corresponding to a clinical trial registered in ClinicalTrials.gov, of which 10 170 pairs (38.1%) were interventional cancer clinical trials. Among these, 9805 pairs (96.4%) were considered appropriate.

Conclusions and relevance: In this cohort study, this data linkage provided a novel data source to study clinical trial enrollment patterns among Medicare patients with cancer on a population level. The presence of the NCT identifiers in claims for Medicare patients participating in clinical trials is likely to improve over time with increasing adherence with the Centers for Medicare & Medicaid Services mandate.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Green reported receiving grants from Mereo BioPharma and personal fees from Clinical Congress Consultants outside the submitted work. Dr Aghajanian reported receiving personal fees from Eisai, Merck, Mersana Therapeutics, Roche, Genentech, AbbVie, AstraZeneca, and Repare Therapeutics and grants from AstraZeneca, Genentech, AbbVie, Clovis, and AstraZeneca outside the submitted work. Dr Landgren reported receiving grants from Amgen, Celgene, Janssen, Takeda, Karyopharm, Multiple Myeloma Research Foundation, Perelman Family Foundation, National Cancer Institute, and US Food and Drug Administration (FDA); personal fees from Glenmark, Adaptive Biotech, Bristol Myers Squibb, Cellectis, Binding Site, and Oncopeptides; and serving on independent data monitoring committees for Theadex, Merck, and Janssen outside the submitted work. Dr Riely reported receiving grants from Novartis, Takeda, Pfizer, Merck, Mirati, and Chugging outside the submitted work. Dr Ip reported receiving personal fees from AstraZeneca and serving on an advisory board for TG Therapeutics outside the submitted work. Dr Bach reported receiving personal fees from United Rheumatology, Foundation Medicine, Grail, Morgan Stanley, NYS Rheumatology Society, Oppenheimer & Co, Cello Health, Oncology Analytics, Oncology Analytics, Magellan Health, Kaiser Permanente Institute for Health Policy, Congressional Budget Office, America’s Health Insurance Plans, Geisinger, EQRx, Meyer Cancer Center of Weill Cornell Medicine, National Pharmaceutical Council, and University of Mexico Comprehensive Cancer Center; grants from Kaiser Permanente and Arnold Ventures; owning stock in Grail, Oncology Analytics, and EQRx; and being employed by Delfi Diagnostics outside the submitted work. Dr Mailankody reported receiving grants from Takeda Oncology, Janssen, Bristol Myers Squibb, Allogene Therapeutics, NCI, and Fate Therapeutics and personal fees from PleXus Education, Physician Education Resource, Evicore, Legend Biotech, Cancer Network, Janssen, and BioAscend outside the submitted work. Dr Lipitz-Snyderman reported receiving grants from the NCI and Cancer Center Support during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Flowchart for Surveillance Epidemiology and End Results–Medicare Patients Included in Analysis
NCH indicates National Claims History. aWe identified unknown as National Clinical Trial (NCT) identifiers of 99999999. bAn NCT match was defined as an NCT identifier that had an associated trial in ClinicalTrials.gov.
See this image and copyright information in PMC

References

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