Off the back of the release of Trilogy Writing & Consulting’s second special edition magazine, EPC sits down with Barry Drees to expand on medical writing trends in the industry.
EPC: In Medical Writing – A Bold New Path: The Future Awaits Us, Lisa A Cloutier at Janssen Research & Development discusses outsourcing trends in medical writing. What do you think the future will hold for medical writing services?
Barry Drees: I have been in medical writing for over 30 years, and it seems that every five years or so, the outsourcing trend pendulum swings back and forth between ‘everything should be done in-house’ and ‘virtual company: outsource everything’. I believe that the ideal solution is somewhere in the middle, where a company maintains a core of medical writing experience but uses outside contractors in times of peak demand (such as large submissions) or for specialist expertise. So, I see a very secure future for contract medical writers.
‘Patient centricity’ has become a staple term in all aspects of the pharmaceutical industry. How do you see this applied in the context of medical writing?
The most important application of patient centricity is the recent requirement for lay summaries to be produced for every clinical study report. This represents a radical departure for most medical writers who were used to either an academic (publications) or regulatory style. However, I believe that it also offers a chance to improve the dreadful reputation that the pharma industry has among the general public by explaining to patients and other members of the public what the industry does and how it does it.
How has technology improved or created challenges within the medical writing industry?
Obviously, technology has vastly improved the process of medical writing in that I can still recall when tables had to be constructed by hand using symbols such as ‘_’ and ‘|’! I am less convinced of other ‘improvements’ such as simultaneous authoring and reviewing, multiple complex levels of document security and password protection, or the use of client-specific macros for things that Microsoft Word does just fine. These seem to give marginal benefit but at considerable cost.
How will medical writing change in the next 20 years?
A few trends that have already begun can be expected to accelerate and even dominate: home office and virtual meetings, increased acceptance of how electronic regulatory documents are actually read with the subsequent abandonment of anachronistic processes (i.e., writing abbreviations out at first mention, which only makes sense if the document is read like a book), and the use of artificial intelligence to automate much of the more mundane aspects of writing. Additionally, I will be bold and make a few more radical predictions: writers will work together with statisticians and data managers for a single integrated procedure, regulatory authorities will expand the orphan drug concept to all drugs to expedite approval, and scientific documentation (and thus medical writers) will be required in ever more fields (cosmetics, nutraceuticals, etc.) where it is currently lacking.
How can strong communication and project management alleviate the challenges in a medical writing department?
When clinical document preparation gets more complicated, it requires the input of more specialists: clinicians, statisticians, regulatory specialists, publishers, drug safety experts, etc. The old paradigm of a medical writer sitting with the main author is steadily disappearing in favour of large teams where communication and expert project management become critical for success. Getting a large team to work towards a common goal is only possible with constant communication and strong leadership.
What advice can you give to new medical writers starting out in the field?
Try to get as much experience with as many different clients, document types, and indications as possible. This will give you a much broader view, and it makes the difference between a competent medical writer and a great medical writer who brings more to their teams than just the ability to produce a document. This flexibility also helps you stay relevant in a field where the guidelines are constantly updated and revised.
Read more in Medical Writing – A Bold New Path: The Future Awaits Us, produced in association with Trilogy Writing & Consulting.
This article is taken from European Pharmaceutical Contractor May 2020, page 38-39. © Samedan Ltd