This is the first posting in a three-part series drawn from ICON’s webinar, “Evolving Best Practices for Working with Authors—Authorship and Beyond.”
Scientists first began publishing their findings in scientific journals more than 350 years ago. Today, as demands in the sciences have evolved, the process of preparing material for submission to medical congresses or journals on scientific developments is complex process. It’s often not thoroughly understood, is fraught with challenges, and for all practical purposes requires supporting technology.
Through this three-part series, we’ll explain guidelines and best practices in:
- Publication planning and development
- Engaging and managing authors
- Using software to manage content development
Publication Planning and Development
Material developed to support or advance clinical and scientific information on a company’s products (whether marketed or in development) is typically developed by the Publications Department to fulfill the company’ scientific/medical objectives. These could include presenting results of protocol-based clinical trials, furthering the understanding of medical literature, or increasing awareness of a disease state or therapeutic area.
The need to publish may be outlined in Medical Affairs’ Strategic Plan or identified in a needs assessment or publication gap analysis. The company’s commercial/marketing departments may provide input to the publication plan itself, but thereafter, must be separated from the process by a “firewall.”
Studies by Independent Investigators
If a report is developed by independent investigators who proposed a trial and assumed all responsibility for the conduct of the study, the company’s role in publishing the report will be very limited.
The company’s review should be restricted to identifying any content involving the company’s intellectual property, patents, or other confidential information and correcting any inaccurate medical or scientific information that directly relates to the company’s product(s). The company must not compensate the investigators.
Reports on Company-Sponsored Studies
Several scientific, editorial, and regulatory bodies have published guidance to help companies follow ethical and transparent publication practices. We recommend reading the following materials prior to embarking on a path to publication:
- Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals