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Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines.

ABSTRACT: Children have historically been underrepresented in randomized controlled trials and multi-center studies. This is particularly true for children who reside in rural and underserved areas. Conducting multi-center trials in rural areas presents unique informatics challenges. These challenges call for increased attention towards informatics infrastructure and the need for development and application of sound informatics approaches to the collection, processing, and management of data for clinical studies. By modifying existing local infrastructure and utilizing open source tools, we have been able to successfully deploy a multi-site data coordinating and operations center. We report our implementation decisions for data collection and management for the IDeA States Pediatric Clinical Trial Network (ISPCTN) based on the functionality needed for the ISPCTN, our synthesis of the extant literature in data collection and management methodology, and Good Clinical Data Management Practices.

SUBMITTER: Greer M

PROVIDER: S-EPMC10512201 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines.

Greer Melody M Garza Maryam Y MY Lee Jeannette J Prior Fred F Tarbox Lawrence L Tobler Jeff J Walden Anita A Zozus Meredith Nahm MN Snowden Jessica J

Contemporary clinical trials 20230203

Children have historically been underrepresented in randomized controlled trials and multi-center studies. This is particularly true for children who reside in rural and underserved areas. Conducting multi-center trials in rural areas presents unique informatics challenges. These challenges call for increased attention towards informatics infrastructure and the need for development and application of sound informatics approaches to the collection, processing, and management of data for clinical ...[more]

PMID: 36738915

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Project description:Importance:It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. Objective:To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Design, Setting, and Participants:Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Main Outcomes and Measures:Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Results:Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10?000, and 18 accepted more than $50?000. Financial payments amounted to a mean of $157?177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7?701?681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Conclusions and Relevance:Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

Dataset Information

Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines.

Publications

Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines.

Similar Datasets

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