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

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Background:: Medical information departments are responsible for maintaining standard response letters to address health careproviders’ inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, andstringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new databecomes available for an inquiry that was previously unanswered, it is not common practice for medical information departmentsto provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact ofreviewing literature to provide an updated response to health care providers. Methods:: We conducted a 1-year retrospectivereview of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that weremissing data via our metrics reporting software and conducted an internal and external literature search to assess if new databecame available. Results:: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequentlyobserved 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 inquiriesthat were previously unanswered. Conclusions:: Medical information departments serve as a resource to answer product-relatedquestions for health care providers. However, data are not always available to provide a response. On discovery of new data, ifmedical information departments followed up with health care providers to share new data, this could potentially increase patientsafety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinicaltrials and publications.

Original languageEnglish
Pages (from-to)385-389
Number of pages5
JournalTherapeutic Innovation and Regulatory Science
Issue number2
StatePublished - 1 Mar 2020



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

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