Flying the industry standard

The introduction of Good Publication Practice (GPP) standards marked an important step towards the ethical and transparent development of publications from pharma- and biotech-sponsored medical research. How can adherence to these standards be ensured, and how can medical communications agencies help accomplish this?

Self-regulation
The environment in which medical research sponsored by pharma and biotech is reported has evolved during the past decade. Industry has taken several initiatives to move towards greater awareness, full transparency and improved practices. GPP guidelines were first published in 2003. The GPP-2 guidelines, published in 2009, can be viewed as the most up-to-date industry standards. They describe the responsibilities of authors, collaborators and industry for developing publications in a responsible and ethical manner.

In addition, the American Medical Writers Association and the European Medical Writers Association have formulated guidance on the role of professional writers in developing publications. GPP standards have been formulated and endorsed by medical publication professionals from both pharma and biotech, medical communications agencies and publishers. As such, these standards represent self-regulation and are not monitored or enforced by regulatory authorities. The International Society for Medical Publication Professionals has implemented a certification programme. Through the Certified Medical Publication Professional credential, integrity is promoted by encouraging adherence to best-practice standards across the industry.

Auditing good practice
The development of GPP standards has been essential for ensuring responsible and ethical practice. However, the dissemination of guidelines and education on standards do not guarantee that companies and individuals actually adhere to best-practice standards. If industry wants to – or ends up needing to – demonstrate adherence, documented evidence is required. One approach is to create auditable processes to evaluate and document adherence to GPP. Quality assurance and auditing are well established on a global level in other fields, such as good clinical practice and market research.

Working to GPP standards
Medical communications agencies partnering with pharma and biotech, authors and publishers, can contribute to GPP adherence by creating robust processes to ensure that all steps in publication development are in line with GPP and evidence of this is properly documented. These steps facilitate the creation of effective auditable processes:

• Educate all staff to understand the intention of responsible publication practices
• Integrate GPP into the company's standard operating procedures so that it becomes an everyday practice
• Document GPP steps and procedures across all projects
• Audit publication development processes for internal tracking, improvement and external validation of adherence
• Innovate processes to facilitate effective adherence to GPP, while minimising bureaucratic paperwork
• Have an in-house champion to stay at the forefront of developments and to drive internal engagement.

An auditable trail of publication development will benefit all partners: the medical communications agency can track and improve its performance of GPP; authors are assured that they direct publications that express their views accurately; publishers are guaranteed that the medical research they publish has been reported in a transparent and ethical manner; and industry can use the auditable trail of documentation as a tool to demonstrate adherence with standards. By operating together with transparency towards high-quality and accurate reporting of medical research, we can have a positive impact on the evidence base that healthcare providers use to make decisions and, ultimately, on patient care.

The Author
Hester van Lier, PhD is programme director at Excerpta Medica
Email her at: h.lier@excerptamedica.com