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Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI

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Abstract

The Medical Information Department of a pharmaceutical manufacturer provides written scientific responses to unsolicited requests from healthcare providers for information on products that extends beyond the product labeling (off-label). These scientific response documents are non-promotional, evidence-based, and scientifically balanced, conforming with internal pharmaceutical manufacturer’s procedures and the Food and Drug Administration (FDA) Draft Guidance on Responding to Unsolicited Requests for Off-Label Information. Members of phactMI™ developed this proposal to offer best practices for content generation of scientific response documents. Scientific response documents review available literature to respond to an unsolicited request; therefore, they are similar in nature to systematic reviews. The sections and elements identified in this proposed best practice guidelines for scientific response documents are based on an adaptation of the sections and elements of systematic reviews. The sections of a scientific response document should include a restatement of the unsolicited request (title); a structured summary (abstract); approved indications, black box warnings, and background information when appropriate (introduction); the literature search information and study selection (methods); summation of data from clinical trials, meta-analysis, case reports, and/or real world evidence, as appropriate (results); treatment guidelines, if applicable and available (discussion); and references. Elements for each section should be included in a scientific response document as appropriate, as some elements are not necessary in some documents, based on the question. These elements were selected for inclusion to address any potential concerns of bias and transparency and reflect the intent that scientific response documents should be non-promotional, accurate, truthful, free of commercial bias, scientifically balanced, and evidence based.

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Acknowledgements

The authors wish to acknowledge the assistance of the following individuals: Mrs. Teresa Flowers, Dr. Meital Avraham, Dr. Asha Philip, Dr. Jean-Michel Planquois, Dr. Prachee Satpute, Dr. Samuel Chung, Dr. Steven Matsuoka, Dr. Kirtida Pandya, Dr. Jason Bradt, and Ms. Marybeth Richards.

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No financial support was received for this publication.

Author information

Authors and Affiliations

  1. Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers The State University of New Jersey, 160 Frelinghuysen Rd, Piscataway, NJ, 08854, USA

    Evelyn R. Hermes-DeSantis PharmD

  2. Global Medical Information, Pfizer, 500 Arcola Rd, Collegeville, PA, 19426, USA

    Renee M. Johnson PharmD, MPH, BCPS

  3. Global Medical Information, Biogen, 225 Binney Street, Cambridge, MA, 02142, USA

    Alysa Redlich PharmD, MBA

  4. Medical Affairs Communications, Bayer Healthcare Pharmaceuticals Inc., 100 Bayer Blvd, Whippany, NJ, 07981, USA

    Bindi Patel PharmD

  5. Global Medical Information, Merck & Co., Inc., 351 N. Sumneytown Pike, MS UG1B-50, North Wales, PA, 19454, USA

    Anne Flanigan-Minnick PhD

  6. US Medical Information, Ipsen US Medical Affairs Division, 106 Allen Rd, Basking Ridge, NJ, 07920, USA

    Susan Wnorowski PharmD, BCMAS

  7. Global Medical Scientific Information, Allergan, 100 Somerset Corporate Blvd, Bridgewater Township, NJ, 08807, USA

    Mabel M. Cortes PhD

  8. US Medical Affairs, Bristol-Myers Squibb, 86 Morris Ave., Summit, NJ, 07901, USA

    Chang Woo Han PharmD

  9. Medical Information and Knowledge Integration, Janssen, 00 Tournament Dr, Horsham, PA, 19044, USA

    Elissa Vine BSc., BSc. Pharm

  10. Global Medical Information, Sanofi, 55 Corporate Dr, Bridgewater Township, NJ, 08807, USA

    Hamza Sarwar PharmD

  11. Knowledge-Centered Capabilities, Eli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA

    Rita Haydar MS, MLIS

  12. Medical Information, Sandoz, 100 College Rd W, Princeton, NJ, 08540, USA

    Ahsan Jamil PharmD

  13. Medical Information, Gilead Sciences, 333 Lakeside Dr, Foster City, CA, 94404, USA

    Tiffany Huang PharmD & Sonia Kaur Sandhu Pharm.D.

  14. PhactMI, PO Box 320, West Point, PA, 19486, USA

    Patrick Reilly PA, MSA

Authors
  1. Evelyn R. Hermes-DeSantis PharmD
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  2. Renee M. Johnson PharmD, MPH, BCPS
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  3. Alysa Redlich PharmD, MBA
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  4. Bindi Patel PharmD
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  5. Anne Flanigan-Minnick PhD
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  6. Susan Wnorowski PharmD, BCMAS
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  7. Mabel M. Cortes PhD
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  8. Chang Woo Han PharmD
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  9. Elissa Vine BSc., BSc. Pharm
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  10. Hamza Sarwar PharmD
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  11. Rita Haydar MS, MLIS
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  12. Ahsan Jamil PharmD
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  13. Tiffany Huang PharmD
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  14. Sonia Kaur Sandhu Pharm.D.
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  15. Patrick Reilly PA, MSA
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Corresponding author

Correspondence to Evelyn R. Hermes-DeSantis PharmD.

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Hermes-DeSantis, E.R., Johnson, R.M., Redlich, A. et al. Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI. Ther Innov Regul Sci 54, 1303–1311 (2020). https://doi.org/10.1007/s43441-020-00151-1

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  • DOI: https://doi.org/10.1007/s43441-020-00151-1

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