Attempts by the health care industry to influence guideline development: a cross-sectional survey of guideline coordinators

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032687

Enrollment

619

Registered

2023-10-11

Start date

2023-10-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survey of guideline coordinators on their experiences with attempts to exert influence during and after guideline development.

Interventions

Group 1: Explorative online survey of a sample of clinical practice guideline (CPG) coordinators in Germany, contacted by e-mail. The sample is drawn from publicly available information from the guide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must be a coordinator of a clinical practice guideline listed in the AWMF register.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Questions: 1) How often do companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups send unsolicited literature for guideline development during guideline development? 2) How often are unsolicited telephone calls/visits by representatives of health care companies (e.g. pharmaceutical industry, medical device industry) or industrial interest groups made during the guideline development process? 3) How often are invitations to participate in events or advisory boards on the currently developed guideline topic issued by companies in the health care sector (e.g. pharmaceutical industry, medical device industry) or industrial interest groups during guideline development? 4) How often were there letters from lawyers requesting changes to the content of the guideline on behalf of companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups after the publication of a clinical practice guideline? 5) How often were there threats of legal action to change the content of a clinical practice guideline by lawyers from companies in the health care sector (e.g. pharmaceutical industry, medical device industry) or industrial interest groups? 6) How often have there been legal settlements between lawyers of the guideline authors/issuing professional society(ies) and lawyers of health care companies (e.g. pharmaceutical industry, medical device industry) or industrial interest groups after guideline publication that have resulted in a change of guideline content ? 7) How often was there a complaint and lawsuit by lawyers from companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups with the aim of changing the content of the guideline or withdrawing the guideline? 8) How often did other types of legal disputes occur after the guideline publication? As this is an exploratory study, there are	—

Measure

Time frame

Questions: 1) How often do companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups send unsolicited literature for guideline development during guideline development? 2) How often are unsolicited telephone calls/visits by representatives of health care companies (e.g. pharmaceutical industry, medical device industry) or industrial interest groups made during the guideline development process? 3) How often are invitations to participate in events or advisory boards on the currently developed guideline topic issued by companies in the health care sector (e.g. pharmaceutical industry, medical device industry) or industrial interest groups during guideline development? 4) How often were there letters from lawyers requesting changes to the content of the guideline on behalf of companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups after the publication of a clinical practice guideline? 5) How often were there threats of legal action to change the content of a clinical practice guideline by lawyers from companies in the health care sector (e.g. pharmaceutical industry, medical device industry) or industrial interest groups? 6) How often have there been legal settlements between lawyers of the guideline authors/issuing professional society(ies) and lawyers of health care companies (e.g. pharmaceutical industry, medical device industry) or industrial interest groups after guideline publication that have resulted in a change of guideline content ? 7) How often was there a complaint and lawsuit by lawyers from companies in the health care industry (e.g. pharmaceutical industry, medical device industry) or industrial interest groups with the aim of changing the content of the guideline or withdrawing the guideline? 8) How often did other types of legal disputes occur after the guideline publication? As this is an exploratory study, there are

—

Secondary

Measure	Time frame
Wishes (for the professional societies, the AWMF, politics, the health care industry) of guideline coordinators on how to deal with attempts to influence guideline development by the health care industry.	—

Countries

Germany

Contacts

Public ContactSabine Gehrke-Beck

Charité - Universitätsmedizin Berlin, Institut für Allgemeinmedizin

sabine.gehrke-beck@charite.de+49 30 450 514119

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026