How to partner with medical writers

Transcription

1 How to partner with medical writers Marion Alzer 7 May 2016

2 Medical writers: who they are and what they do Who are they? Scientific background: Healthcare, life sciences, other sciences And communication skills: On-the-job training, workshops by professional bodies, formal degree in medical writing What do they do? Write, edit or develop materials about medicine and health by collecting, organising and presenting information in a manner appropriate for the target audience* *Source: Accessed on 24 April 2016.

3 Medical writing involves writing different types of documents for different purposes, and for different audiences* Target audience Examples Regulatory writing Documents related to pharmaceutical development Clinical trial personnel, investigators, pharmaceutical companies, regulatory authorities Clinical study protocols, patient informed consent forms, clinical study reports, regulatory submission documents Medical communications Documents related to medicine and healthcare Healthcare professionals, academic researchers and patients Journal articles, conference abstracts, posters, presentations, reports; web content; educational materials (textbooks, slide decks, e-learning modules)** *Source: Sharma S. How to become a competent medical writer? Perspect Clin Res. 2010;1: Accessed on 23 April **Source: Baldwin, H. Introduction to Medical Writing. Webinar. EMWA, 15 January 2015.

4 Medical writers: what they can do for you Provide professional services Writing Medical translation Editing and proofreading Quality control Consultancy Training Provide skills and expertise Taylor information to level of understanding of target audience Transform complex concepts into simple and clear language Comply with guidelines: Medical writers help you get your message across and save you time!

5 Medical writers: what they expect from you 1. Set the scene: introduce yourself and your organisation 2. State your needs and expectations. Be specific! 3. Outline your project: Scope: 4-module learning program on Wonderdrug with illustrations for online access; 300-word abstract on XYZ for submission to The Journal, Purpose: raise awareness, provide information, educate/train, promote an event, Target audience: patients, caregivers, healthcare professionals, general public, Format: Word document, PowerPoint slide deck, web-based content, Timelines: Be realistic!

6 Medical writers: what they expect from you 4. Define responsibilities for: Providing source materials Tables, graphics, lay-out Coordinating review (how many rounds?) and integrating comments from reviewers Quality control: spelling, grammar, punctuation, line and page breaks, endnotes, consistent use of wording Obtaining copyrights Final sign-off Submission to the editor 5. Provide examples if available

7 Based on the information you provide, the medical writer can Assess whether they are the right person for the job or recommend someone else Determine whether they can keep the proposed timeline Prepare a cost estimate Perform the work and deliver according to your specifications

8 Medical writers: where to find them Global business networks, e.g. Local business networks, e.g. Xing in German-speaking areas Medical writers associations Medical writing agencies Internet searches Recommendations through your own networks

9 Medical writers: where to find them

10

11 Medical writers: where to find them or MWA/Freelance/Freelanc e_directory/emwa/freel ance/freelancer_listing.a spx?hkey=e5c0680b- 844e-40a2-bb12- cb84406f9476

12 5th EMWA freelance business survey, 2015* 181 freelancers replied: 169 based in Europe, 12 based outside of Europe, all working for clients in Europe Average percentage of total work provided by: Medical communication agencies 43% Pharmaceutical companies 28% Clinical research organisations 13% Non-profit organisations 3% Median hourly rates charged: Medical communications writing: EUR 75 (range 0-348) Regulatory writing: EUR 90 (range ) *Source: Edwards J, Reeves A, Jacobs A: Medical Writing. Fifth EMWA freelance business survey. Medical Writing 2016; 25 (1):47-51

13 Project budgeting examples Patient informed consent document: ~ 2.5 to 4 working days 4-page patient leaflet: ~ 3 to 5 working days Depending on various factors such as: Familiarity of medical writer with subject matter Time needed for literature research or collating materials Level of detail expected Rounds of review Technical aspects, e.g. layout and formatting Coordinating tasks Remember: every project is unique!

14 Example of collaboration with a medical writer: European LeukemiaNET treatment recommendations in CML (2006, 2009, 2013) Problem: Key guidelines in treating CML difficult for patients published only in English journals not open access Objectives: Give patients easy access to useful information in language they can understand Solution: Work with a medical writer

15 CML Advocates Network s patient-friendly summary of European LeukemiaNET CML Recommendations Summary produced by European workgroup of patient advocates and four CML experts, supported by medical writer English Official translation into 9 languages professional medical translator + review by local haematologist Community translation by our members local translator + review by local haematologist Arabic French German Italian Polish Portuguese Russian Spanish Turkish Albanian Danish Azerbaijani Dutch Bulgarian Georgian Chinese Serbian Croatian Czech coming soon

16

17 CML Advocates Network s patient-friendly summary of ELN CML Recommendations (2013) English full-text views Italian 4910 full-text views Spanish 3479 full-text views German 5248 full-text views these are only the online versions (not PDF)

18 Example of collaboration with medical writer: CML Clinical Trials Database Project started in 2013 Medical writer = main contact for collecting and processing information, and updating database on an ongoing basis Currently 29 trials listed In parallel, 26 trials listed in separate database for Germanspeaking regions at

19 Thank you Marion Alzer Freelance Medical Writer & Medical Translator for CML Advocates Network

20 Back-up slides

21 5th EMWA freelance business survey: Proportion of work from non-profit organisations* Web-based survey from mid-january to mid-march respondents (freelancers) based in Europe or working for clients in Europe Work providers Average percentage of total work undertaken (%) Medical communications agencies 43 Research-based pharmaceutical companies Clinical research organisations Non-profit organisations 3 28 *Source: Edwards J, Reeves A, Jacobs A: Medical Writing. Fifth EMWA freelance business survey. Medical Writing 2016; 25 (1):47-51

22 Hourly rates* Type of work Number of respondents Minimum rate Median rate Maximum rate Writing (total) Medical Communications writing Regulatory writing Editing All rates are in euros per hour; where respondents had reported rates in British pounds, these were converted to euros at a rate of 1.35 *Source: Edwards J, Reeves A, Jacobs A: Medical Writing. Fifth EMWA freelance business survey. Medical Writing 2016; 25 (1):47-51

23 5th EMWA freelance business survey* Web-based survey from mid-january to mid- March 2015 Survey was open to anyone conducting freelance medical writing activities in Europe, including non-members of EMWA Work providers Med comms agencies Pharma CROs Publishers Non-profit *Source: Edwards J, Reeves A, Jacobs A: Medical Writing. Fifth EMWA freelance business survey. Medical Writing 2016; 25 (1):47-51

24