Publication Practices in Medical Technology and Pharmaceutical CompaniesMary Jo Williamsa, Michael Witteka, Angeline Carlsonb

aMedtronic Inc, Minneapolis, MN, USA; bData Intelligence Consultants LLC, Eden Prairie, MN, USA

A b s t r A c tObjectives: To understand publication planning and evidence publication in medical device, pharmaceutical and biotechnology companies. Research Design and Methods: A 15-question survey was sent to company representatives (N=12,146) using Survey Monkey. Questions included importance of publication planning and execution, publication policies, resources dedicated to publication activities, roles and responsibilities within the company related to publication planning and publishing, and familiarity with good publication practices. Initial e-mail correspondence provided an active link to the survey with a response request within four weeks. A reminder e-mail was sent two weeks following the initial request. Chi-square was used to test differences in responses by company type. Results: 92 responses were received (28 pharmaceutical, 24 medical device, 14 biotechnology and 26 other--primarily medical communication firms and excluded from further analysis). A significantly lower proportion (p<0.05) of respondents from medical device companies indicated that publication planning and publishing were very important; a higher proportion indicated that levels of resources devoted to publication planning and publishing are less than appropriate. A significantly greater proportion of pharmaceutical and biotechnology companies indicated that publication management staff oversees publication activities and reported having a defined process in place for publication planning (p<0.05). Awareness of GPP2 guidelines was significantly higher (p<0.05) for pharmaceutical and biotechnology company representatives. Conclusions: Despite low response rate, information obtained from the survey indicate differences between medical device and pharmaceutical/biotechnology companies in the importance and resource allocation for publication activities.

O t H E r K E Y F I N D I N G s• 86% of pharmaceutical companies, 83% of

biotechnology companies and 63% of medical device company respondents indicated that they follow a defined publication planning process.

• 89% of pharmaceutical companies, 71% of biotechnology companies and 21% of medical device company respondents indicated that they have publication management staff to participate in publication planning.

• The majority of pharmaceutical and biotechnology companies have publication management staff that oversee publication planning; about one-third of medical device manufacturers rely on marketing and another one-third rely on clinical staff to oversee publication planning.

c O N c L U s I O N sSurvey responses indicate major differences in the availability of publication planning resources between pharmaceutical, biotechnology and medical device companies.The major challenges for medical device companies are: • Increasing the importance of publication planning for

evidence dissemination• Increasing resource levels to develop and execute

publication plans• Increasing awareness of GPP2 practices to guide

publication planning• Creating publication policies to guide activities.

b A c K G r O U N D A N D M E t H O D s• Pharmaceutical companies have a longer history of publication planning and processes

to support drug therapies. Medical device, biotechnology and diagnostic companies have only recently begun to define publication planning activities for their therapies.

• A 15-question survey was disseminated via Survey Monkey to 12,146 companies representing pharmaceutical, biotechnology, medical device and diagnostic manufacturers.

• The intent of analysis was to determine differences in the publication practices between medical technology and pharmaceutical companies.

P r I M A r Y F I N D I N G sResponses were received from 92 companies (28 pharmaceutical, 24 medical device, 14 biotechnology and 26 other companies excluded from analysis due to their focus on medical communications). All differences were statistically significant (Chi-square, two-sided, p-value <0.05).

Acknowledgements: Michele Kantrowitz, ISMPP, survey e-mail list and hosting survey website; Martin Gold, Technology Access Partners, LLC, survey e-mail list.

Importance of Publication Planning Importance of Publishing Evidence

Adequacy of Resources for Publication Planning Adequacy of Resources for Publishing

Availability of a Publication Policy Awareness of Good Publication Practices 2 (GPP2)

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