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Guidelines for Clinical Custom Content

Guidelines for Clinical Custom Content

Clinical Custom Content is written for audiences working in health-care and adjacent industries. We take a journalistic approach, making the content accessible to practitioners with varying degrees of familiarity with the subject.

Content comes in two varieties: Branded and Unbranded. Which options to choose will depend on our partner’s specific needs and goals.

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

Material that is covers subjects relevant to clinicians and physician-researchers, but without mentioning any specific drugs or devices, is less regulated, but must still fulfil some basic parameters.

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.

Branded editorial content

These articles are for specific marketing messages about approved drugs and devices, tightly targeted to audiences of health-care professionals (HCPs), with promotional campaigns that are geographically limited.

  • 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 There must be no unpublished data.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.

Unbranded editorial content

These articles primarily raise awareness and demonstrate thought leadership and research in a disease area. They often provide foundational knowledge of a disease and its mechanisms for a clinical group who might later encounter an approved drug or device.

  • Brand names. Cannot mention specific drugs, devices or clinical diagnostics. Can discuss drug classes in a broad, objective sense, if appropriate
  • Investigational drugs and devices. Cannot include clinical trial data relevant to specific drugs or devices
  • Editorial tone. Articles build an association between our partner and a developing area of biomedical research, whether drug or device development; new pathways, targets or biomarkers; common diagnostic challenges; or other aspects of translational research. These pieces have a more conversational tone.

Article presentation

  • Online location. Branded Clinical Custom Content will appear on Springerlink, whereas Unbranded content can appear on Nature or Springerlink.
  • Gating. If required, Springerlink articles can open with a pop-up window such that the reader has to affirm they are an HCP in order to access the content.
  • Article labelling. All clinical custom content will be labelled as “ADVERTISEMENT FEATURE”.
  • 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. Branded 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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