Evidence map›Paper›PMID 41559426›Full record

ArticlePharmaceutical medicine2026

Best Practices for Medical Information Global Response Documents from phactMI and MILE.

Susan Wnorowski, Faith Niemoller, Anja Glaetzer, Robert Tamburri, Elissa Vine, Franziska Flick, Meera Patel, Evelyn R Hermes-DeSantis

Abstract read
In one paragraph

Article in Pharmaceutical medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Susan WnorowskiIpsen, Hillsborough, NJ, USA.ORCID 0000-0002-9659-4784
Faith NiemollerBiogen, Cambridge, MA, USA.ORCID 0009-0001-7601-0913
Anja GlaetzerSanofi, Morristown, NJ, USA.ORCID 0000-0002-4521-3419
Robert TamburriJohnson & Johnson, Horsham, PA, USA.ORCID 0009-0009-3304-4994
Elissa VineJohnson & Johnson Innovative Medicine, Titusville, NJ, USA.ORCID 0009-0006-6577-0729
Franziska FlickMerck KGaA, Darmstadt, Germany.ORCID 0009-0006-0121-7545
Meera PatelBayer, Whippany, NJ, USA.ORCID 0000-0002-3792-8879
Evelyn R Hermes-DeSantisPhactMI, 5931 NW 1st Place, Gainesville, FL, 32607, USA. evelyn@phactMI.org.ORCID 0000-0001-5658-3899

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Medical information departments within pharmaceutical companies play a critical role in addressing unsolicited healthcare professionals' inquires with accurate, evidence-based, and balanced medical information through scientific response documents. Global response documents (GRDs) aim to harmonize information between global and local teams and the end product, the scientific response document. To address the challenges associated with the development and maintenance of global response documents and this harmonization, phactMI and Medical Information Leaders Europe (MILE) convened an international expert panel representing 11 major pharmaceutical companies. Over months of discussion and deliberation, the panel developed consensus-based best practices for the creation and management of global response documents. The experts contributed nuanced insights regarding optimal document structure and format that consider various stakeholders while maintaining medical accuracy. Consensus was achieved via a structured survey with a 75% approval threshold for each best practice. Overall, GRDs are essential tools for pharmaceutical companies, offering accurate evidence-based responses to healthcare professionals. While companies may respond to patient inquiries as well in different formats (verbal vs written), GRDs are exclusively intended for healthcare professionals currently. Best practices for GRD development include: being focused on a single topic, developed in a label-agnostic manner, utilize the most robust scientific information available, developed up to 12-15 months prior to launch, have regular feedback in a structured approach from local teams, follow internal guidelines and work instructions, and be peer reviewed internally whenever new data are added. In addition, local response documents or scientific response documents should be based on a GRD that is localized with appropriate documentation. Overall, GRD development is a collaborative and innovative approach (including interactive formats), supported by defined metrics (including response time) and ongoing updates to ensure global relevance and compliance.

Indexed as

Drug IndustryMedical InformaticsConsensusDocumentationHealth PersonnelHumans

Identifiers

PMID41559426
PMCPMC12988992

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.