Key Findings From the AMWA-CMR Research Project (Open Session 11 and Poster)

by Sue Hudson

How are medical communication departments organized in major pharmaceutical companies? How is the productivity of writers and editors measured? What impact does outsourcing have on document quality or on productivity?  In an open session and poster presentation at this year's conference, results of a landmark 2009 survey conducted by AMWA and CMR International were reviewed.

Key findings:
1. Regulatory departments in most companies who responded to the survey outsource many document types, but not Phase 1, 2, and 3 clinical study reports.
2. The fact that 100% of respondents’ companies outsource the development of protocols for clinical studies was a surprise to the audience in the AMWA open session; discussion centered around the critical nature of these publications to any clinical study. (Maybe future research could find out why they’re outsourced.)
3. About half of manuscript writing is outsourced by big pharmaceutical and biotech companies that responded to the survey (good news for freelances and agencies).
4. Only 2.5% of respondents used out-of-country vendors (defined as vendors outside the country of the company doing the work; for example, for a company in Germany, sending a project to the U.S. would be out-of-country).
5. Document quality and lack of face-to-face communication were cited as obstacles to out-of-country outsourcing.
6. Resource constraints are the most common reason for the outsourcing of documents. Good experience with vendors, specialized vendor expertise, and cost were also noted.
7.   Managers in 57% of companies said the quality of work done by in-house staff was better than that of vendors.
8. Managers in 62% of companies said there was no difference between the productivity of in-house staff and outside vendors; when a difference was seen, in-house staff was more productive…. BUT
9. Documents developed by outside vendors took longer to produce than those developed by in-house staff.

(And 10. Research is hard work and takes a long time.)

A visionary keynote address

Dr. Karen Woolley is the first AMWA keynote speaker in my experience who is one of us--a medical writer. And what a medical writer she is! In addition to running a large medical writing firm based in Australia, she is internationally engaged in advancing our profession through teaching, research, and advocacy for higher educational and ethical standards.

In her talk Thursday, Karen outlined 3 major problems facing medical writers, especially those of us who work on journal manuscripts:

• Lack of evidence that we add value to our projects and are ethical
• Lack of a truly international approach to training
• Isolation from other stakeholders, particularly journal editors

For each problem, she suggested actions that the profession can take and actions that individual members can take.

To address the first problem, Karen urged members to compete for the new award AMWA created for original research by AMWA members. The research must explore the value added by medical writers and editors and must be published in a peer-reviewed journal indexed by PubMed. The winner will receive a $2000 honorarium. (For more information, look under "What's New?" on the AMWA home page.) Aside from competing for that award and the new student research award, individuals can help by learning the rules of medical publishing, especially the AMWA Position Statement, Good Publication Practice for Pharmaceutical Companies (soon to be updated), and the Uniform Requirements for Manuscripts.

Even more emphatically, Karen called on us to reject ghostwriting assignments, because short-term financial gain for individuals is creating long-term professional pain for everyone in the profession. “That has got to stop,” she said. She urged us to use the PLoS Medicine checklist to document the specifics of our collaborations with authors.

As part of formal research, Karen and colleagues have investigated manuscript retraction rates to identify contributing factors. They presented some of this research at last month’s 6th International Congress on Peer Review and Biomedical Publication. One critical issue, Karen believes, is lack of training in medical writing. Effective training needs to be available globally, given that clinical trials are booming in sites such as China and India.

R-E-S-P-E-C-T

Karen Woolley delivered an impressive keynote speech titled "Getting Respect--Two Steps Forward and?" She addressed head-on the challenges of banishing the practice of ghostwriting in medical communication and the critical importance of ethics in medical writing and editing.

Woolley is the CEO of ProScribe Communications, and an adjunct associate professor at the University of Queensland, University of the Sunshine Coast, Australia.

The blog will have more on the speech later. Full coverage will be available in the AMWA Journal. The speech was audiotaped and will be posted at a later date in the members-only section of the AMWA web site.

Articles referenced by Woolley in her talk:

Gøtzsche, PC et al. What Should Be Done To Tackle Ghostwriting in the Medical Literature? [Authors include Karen Woolley and Cindy Hamilton, 2008-09 AMWA president.]

Woolley, KL. Goodbye Ghostwriters! How To Work Ethically and Efficiently With Professional Medical Writers.^*