Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review

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Abstract

Background: Medical information departments are responsible for maintaining standard response letters to address health care providers’ inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. Methods: We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Results: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were “use in special populations” (32%), “drug interactions” (27%), and “adverse events and safety” (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. Conclusions: Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.

Original languageEnglish
JournalTherapeutic Innovation and Regulatory Science
DOIs
StatePublished - 1 Jan 2019

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Health Personnel
Clinical Trials
Drug and Narcotic Control
United States Food and Drug Administration
Patient Safety
Drug Interactions
Publications
Software
Safety
Population

Keywords

  • drug information
  • medical information
  • medical inquiries
  • oncology data gaps
  • standard response letters

Cite this

@article{a9e5d5965b614ecbaf3816e791f4803f,
title = "Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review",
abstract = "Background: Medical information departments are responsible for maintaining standard response letters to address health care providers’ inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. Methods: We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Results: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7{\%}). The 3 most frequently observed inquiry topics were “use in special populations” (32{\%}), “drug interactions” (27{\%}), and “adverse events and safety” (23{\%}). After performing an internal and external literature review, we developed standard response letters for 30{\%} of medical inquiries that were previously unanswered. Conclusions: Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.",
keywords = "drug information, medical information, medical inquiries, oncology data gaps, standard response letters",
author = "Shanada Monestime",
year = "2019",
month = "1",
day = "1",
doi = "10.1177/2168479019841319",
language = "English",
journal = "Therapeutic Innovation and Regulatory Science",
issn = "2168-4790",
publisher = "SAGE Publications Inc.",

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T2 - A Retrospective Review

AU - Monestime, Shanada

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N2 - Background: Medical information departments are responsible for maintaining standard response letters to address health care providers’ inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. Methods: We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Results: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were “use in special populations” (32%), “drug interactions” (27%), and “adverse events and safety” (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. Conclusions: Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.

AB - Background: Medical information departments are responsible for maintaining standard response letters to address health care providers’ inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. Methods: We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Results: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were “use in special populations” (32%), “drug interactions” (27%), and “adverse events and safety” (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. Conclusions: Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.

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