Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

Ashley M. Hopkins; Natansh D. Modi; Ahmad Y. Abuhelwa; Ganessan Kichenadasse; Nicole M. Kuderer; Gary H. Lyman; Michael D. Wiese; Ross A. McKinnon; Frank W. Rockhold; Aaron Mann; Andrew Rowland; Michael J. Sorich

doi:10.1001/jamaoncol.2023.3996

Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

Ashley M. Hopkins, Natansh D. Modi, Ahmad Y. Abuhelwa, Ganessan Kichenadasse, Nicole M. Kuderer, Gary H. Lyman, Michael D. Wiese, Ross A. McKinnon, Frank W. Rockhold, Aaron Mann, Andrew Rowland, Michael J. Sorich

College of Medicine and Public Health

Research output: Contribution to journal › Article › peer-review

12 Citations (Scopus)

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Abstract

IMPORTANCE

The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized.

OBJECTIVE

To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials.

DESIGN, SETTING, AND PARTICIPANTS

From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis.

EXPOSURES

Request for IPD from 91 clinical oncology trials indicated as eligible for the request.

MAIN OUTCOMES AND MEASURES

The utility and completeness of the IPD and supporting documents provided.

RESULTS

The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted.

CONCLUSIONS AND RELEVANCE

In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

Original language	English
Pages (from-to)	1621-1626
Number of pages	6
Journal	JAMA Oncology
Volume	9
Issue number	12
Early online date	5 Oct 2023
DOIs	https://doi.org/10.1001/jamaoncol.2023.3996
Publication status	Published - Dec 2023

Keywords

Pharmaceutical industry
Individual-participant data (IPD)
Data sharing
Industry-sponsored clinical trials

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1001/jamaoncol.2023.3996Licence: CC BY

Final published versionFinal published version, 384 KBLicence: CC BY

Cite this

@article{19976ea4001148e89aa2e4b48eb825d5,

title = "Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages",

abstract = "IMPORTANCE The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized. OBJECTIVE To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials. DESIGN, SETTING, AND PARTICIPANTS From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis. EXPOSURES Request for IPD from 91 clinical oncology trials indicated as eligible for the request. MAIN OUTCOMES AND MEASURES The utility and completeness of the IPD and supporting documents provided. RESULTS The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted. CONCLUSIONS AND RELEVANCE In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.",

keywords = "Pharmaceutical industry, Individual-participant data (IPD), Data sharing, Industry-sponsored clinical trials",

author = "Hopkins, {Ashley M.} and Modi, {Natansh D.} and Abuhelwa, {Ahmad Y.} and Ganessan Kichenadasse and Kuderer, {Nicole M.} and Lyman, {Gary H.} and Wiese, {Michael D.} and McKinnon, {Ross A.} and Rockhold, {Frank W.} and Aaron Mann and Andrew Rowland and Sorich, {Michael J.}",

year = "2023",

month = dec,

doi = "10.1001/jamaoncol.2023.3996",

language = "English",

volume = "9",

pages = "1621--1626",

journal = "JAMA Oncology",

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publisher = "American Medical Association",

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TY - JOUR

T1 - Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

AU - Hopkins, Ashley M.

AU - Modi, Natansh D.

AU - Abuhelwa, Ahmad Y.

AU - Kichenadasse, Ganessan

AU - Kuderer, Nicole M.

AU - Lyman, Gary H.

AU - Wiese, Michael D.

AU - McKinnon, Ross A.

AU - Rockhold, Frank W.

AU - Mann, Aaron

AU - Rowland, Andrew

AU - Sorich, Michael J.

PY - 2023/12

Y1 - 2023/12

N2 - IMPORTANCE The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized. OBJECTIVE To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials. DESIGN, SETTING, AND PARTICIPANTS From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis. EXPOSURES Request for IPD from 91 clinical oncology trials indicated as eligible for the request. MAIN OUTCOMES AND MEASURES The utility and completeness of the IPD and supporting documents provided. RESULTS The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted. CONCLUSIONS AND RELEVANCE In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

AB - IMPORTANCE The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized. OBJECTIVE To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials. DESIGN, SETTING, AND PARTICIPANTS From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis. EXPOSURES Request for IPD from 91 clinical oncology trials indicated as eligible for the request. MAIN OUTCOMES AND MEASURES The utility and completeness of the IPD and supporting documents provided. RESULTS The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted. CONCLUSIONS AND RELEVANCE In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

KW - Pharmaceutical industry

KW - Individual-participant data (IPD)

KW - Data sharing

KW - Industry-sponsored clinical trials

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SN - 2374-2437

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JO - JAMA Oncology

JF - JAMA Oncology

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ER -

Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

Abstract

Keywords

UN SDGs

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