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The impact of regulatory changes on publication planning

Planning_MAP

In a recent issue of “The MAP Newsletter” from the International Society for Medical Publication Professionals (ISMPP), Karen King and Jason Gardner from Complete Medical Communications discuss how publication planning is evolving in the face of recent regulatory changes.

The authors detail new public disclosure laws including the Final Rule from the National Institute of Health, which mandates that clinical trial data must be submitted to ClinicalTrials.gov within 12 months of the study’s primary completion date. The authors suggest that traditional publication planning strategies that include holding back data releases to coincide with key congresses or product launches are likely to stop, and describe how there has already been a move away from this approach towards publishing data as soon as they are available. With the Final Rule coming into effect in 2018, the authors suggest that publications in the future may be timed to coincide with results appearing on the ClincalTrials.gov website. Due to the 12-month time restriction for disclosing results, speed will likely become one of the most important factors in publication planning, and upfront and early planning will be essential. The authors provide recommendations on how this can be achieved moving forwards.

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Summary by Alice Wareham, PhD, from Aspire Scientific


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