Creating and restoring trust

Best practices in medical publications have evolved significantly during the past decade. Many of the challenges that regulatory agencies, industry, journals and communications agencies are trying to address relate to transparency in the process and dissemination of medical knowledge and product data.

Conflicts of interest
In publications, transparency requires disclosure and acknowledgement, wherein all contributors to scientific publications disclose relationships that could be seen as introducing bias, and all those involved in the development of the published manuscript are either authors, if appropriate, or acknowledged.

The controversy surrounding the concept of ghostwriting has been one of transparency: who contributed to a manuscript? What was their role? Are there any potential sources of bias? Industry standards, such as the recently updated Code of Ethics from the International Society for Medical Publication Professionals, clearly indicate that disclosure and acknowledgement are key elements of good publication practice. Further, recent dialogue is calling on peer reviewers, editors and journals themselves to declare their conflicts of interest. These are not just industry issues – academic researchers must also disclose relationships, as promotion and tenure decisions, as well as grants and funding, are tied to publication records.  

Study reporting
Transparency elements specific to clinical trials are registration and data dissemination, which flow from legislative and policy efforts, for example The European Union Drug Regulating Authorities Clinical Trials and the Food and Drug Administration Amendments Act. These elements ensure transparency as to what studies are being conducted and the results from those studies, which in turn raises the challenge of publishing negative or inconclusive studies that have historically been less likely to be published, even though they may be of medical or scientific value.

As with disclosure, this issue goes beyond industry, as journals have been less interested in publishing negative or even neutral studies, and academic researchers face just as much pressure to obtain and publish positive results as their industry peers. With the advent of clinical trial and data registries, publications arguably take on an even more crucial role: providing context and interpretation to publicly available data tables. Journals, editors, investigators and industry need to work together to ensure the timely publication of manuscripts that provide key contextual information and critical discussion.      

A transparent future
Transparency is a global issue, beyond industry's role in medical publications. The EMEA has issued strict guidelines for how its experts may interact with industry, which includes the calculation of a risk score. Recent reports suggest that advocacy groups may not be fully disclosing industry funding, even though it has been disclosed by industry. Outside the scientific and medical arena, economists and other financial professionals have been criticised for not disclosing relationships with governments and the financial services sector.

Government employees, including a US Supreme Court Justice and a government investigator in Northern Ireland, have been publicly criticised for failing to disclose relationships with political organisations and companies. In the UK, failure of Members of Parliament to disclose reimbursed expenses publicly led to accusations of misuse of funds and months of investigation. Transparency is fundamentally about creating and restoring trust and will continue to be a central theme in the future of publication planning, and society in general.


The Author
Julia Ralston, president & CEO, MedErgy HealthGroup
jralston@medergygroup.com

Jason McDonough, PhD, CMPP, vice president of medical strategy, MedErgy HealthGroup
jmcdonough@medergygroup.com