TY - JOUR
T1 - Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters
T2 - A Retrospective Review
AU - Monestime, Shanada
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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.
AB - 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.
KW - drug information
KW - medical information
KW - medical inquiries
KW - oncology data gaps
KW - standard response letters
UR - http://www.scopus.com/inward/record.url?scp=85079591435&partnerID=8YFLogxK
U2 - 10.1007/s43441-019-00066-6
DO - 10.1007/s43441-019-00066-6
M3 - Article
C2 - 32072589
AN - SCOPUS:85079591435
SN - 2168-4790
VL - 54
SP - 385
EP - 389
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 2
ER -