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Guidelines for Clinical Custom Content

Guidelines for Clinical Custom Content

Clinical Custom Content is content for a difficult-to-reach clinical audience. We have used evidence-based research to design articles to fit in with our readers’ busy schedules, with content that aims to fill their information needs.

Material that discusses medicinal drugs and devices is highly regulated, and we have set out some non-exhaustive guidelines for clinical content we will create for our clients.

These guidelines are not intended to be a definitive summary of the law or a substitution for understanding the legal and regulatory framework that applies to medicines and medical devices.

The client is responsible for ensuring the content complies with the appropriate* legal and regulatory rules.

Editorial content

  • Approval status. Content will cover approved medicinal drugs or medical devices only, and must make clear which countries they are approved and where they are not. Content must not be directed to audiences outside the countries in which the drug or device has been approved.
  • Investigational drugs and devices. No details of planned or ongoing clinical trials or investigations can be included.
  • Brand names. Brand names for medicinal products should only be used if the products have been approved by the appropriate agencies*.
  • Claims. All content must be consistent with the medicinal drug or medical device’s approval. Any claims about the efficacy or safety of a medicinal product must be supported by statistically significant evidence published in the primary, peer-reviewed literature and/or the approved label. Relevant publications will be cited in the article. There must be no unpublished data. The article should not state or imply a medicinal drug or a medical device is safe.
  • Indications. Medicinal drugs can only be discussed in relation to the approved indications, for the approved audiences, at the approved doses – as per the approved label. No off-label discussion can be included. It should be made clear if a medicinal drug or medical device is not indicated for a particular disease, condition or population in certain territories.
  • Fair and balanced. Published results cannot be cherry-picked: adverse as well as beneficial effects must be reported.
  • Editorial tone. The content must not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicinal drug or medical device. The articles will focus on the scientific evidence. None of the reporting, including any quotes from interviewees, shall be overly enthusiastic, misleading or exaggerated. Use of adjectives will be limited.
  • Data presentation. Any data, including in chart form, must be from the published literature and have its full context. Where feasible, actual numbers will be used rather than or in addition to percentages. Data should be presented in a way to give a clear, fair, balanced view and not mislead.
  • Comparisons. Any comparisons must not create confusion with another product or discredit/denigrate a competitor’s product. Comparisons must be accurate, balanced, fair and supported with peer-reviewed papers.

Article presentation on

  • Gating. If required, articles can open with a pop-up window such that the reader has to affirm they are a health-care professional in order to access the content.
  • Article labelling. All clinical custom content will be labelled as “ADVERTISEMENT FEATURE” and “FOR HEALTHCARE PROFESSIONALS ONLY”.
  • Sponsorship declaration. Sponsorship of the content will be declared and visible to readers. The client’s logo, that links to the homepage, will also be clearly visible at the start of the article.
  • Additional materials. Articles will include Brief Summary/Summary of Product Characteristics (SmPC), along with any other information and mandatory text, as required by the relevant healthcare agencies*.

*Relevant healthcare agencies are government or regulatory authorities responsible for the authorization and regulation of medicinal drugs and/or medical devices in the home country(ies) of the client; the contracting Springer Custom Media team; and the target audience(s).

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