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Medical Writing & Submissions Part II: More of Your Top Questions Answered

Medical Writing & Submissions Part II: More of Your Top Questions Answered
26 March 2019

Tony Womack began his career in medical writing in 1997 and today oversees the medical writing department at Synteract.

“You may have five million data points in a massive study database, so you can string together a hundred stories based on that data, but there is one story that needs to be told at the completion of a clinical trial,” says Womack, about the role of medical writing. “Good writing is the distinction between summarizing the analysis versus telling the sponsor’s story the way it should be told.”

We sat down with him for answers to more of the top questions on medical writing that he receives. Please see Part I of this blog, as well, for answers to more top questions.

Q: Why do both medical writing and safety groups budget for serious adverse event (SAE) narratives?
A: SAEs for medical writing and safety each have a unique purpose  and are not interchangeable.

1. The safety group is tasked with writing real-time narratives during the study. For example, if a subject in a study has a heart attack, this event needs to be written up and submitted, on unverified data, immediately.

2. According to the International Conference on Harmonisation (ICH) tripartite guideline on the Structure and Content of Clinical Study Reports, a CSR should include narratives for serious adverse events, but these narratives are written after the study is over and the clinical database is reconciled with the safety database and both are locked. Each patient narrative may contain the data in many safety narratives. In the example above of the patient who had a heart attack, perhaps he/she also broke a leg. These two events would be included in one CSR narrative describing everything that happened to that patient whereas the safety group would have written two narratives to describe the two events. Again, the medical writer is telling the whole story.

Q: Do we need an interim report for every interim analysis, before data collection has been completed?A: The need for interim reports is pretty rare. A sponsor might need an interim report if it is planning to file an NDA based on the interim cut-off data while the study is ongoing. In this case, the sponsor and CRO can cut the data, write the report, file it with FDA as part of the NDA, and when the study is over, revise the CSR to make sure the data is updated and final. 

Q: How long does it take to write a protocol?
A: Once the protocol synopsis (the design of the study, inclusion/exclusion criteria, objectives, assessments, endpoints, schedule of events, and so on) is final, it takes four weeks or less to turn it into an ICH compliant protocol. Developing the synopsis is not solely a medical writing responsibility and involves statisticians and other experts. The time needed to design a study (i.e., produce a protocol synopsis) can take a long time, particularly if the sponsor is unclear on their objective or is awaiting input from the FDA but once the synopsis is final we can produce the full protocol in about a month.    

Q: Can you compress your timeline? What’s involved in doing this?
A: Yes, on occasion we can compress timelines. However, generally there are few good reasons to do so. Exceptions might include being on a critical path for an NDA filing deadline, or during the sale of a compound or company.

At Synteract, we strive to provide a quality draft that has been closely reviewed by a quality review team in medical writing, the lead statistician, and a senior person on the medical writing team, to get it as close to perfect as possible, all within 20 working days. There are also ways to speed and compress the review process, potentially saving a few weeks overall.

Q: Can you deliver a CSR in a format ready to drop into an XML backbone?
A: Yes. This is our standard deliverable. 

Q: Do you have a CSR template?
Yes. Our template incorporates the ICH guidelines. We can use it, or we are happy to use yours. 

Q: Where does Synteract excel in medical writing?
A: The Synteract global medical writing team members based in the US and Germany have an average of about 15 years of experience and are excellent at collaborating and figuring out how to get things done in an efficient, effective way. Of course, they are all good writers, as that’s the first requirement of being a medical writer. We are also on top of the constantly changing regulatory guidelines. We are already working with some U.S.-based companies adopting the new requirements of EU Regulations, as they don’t violate the existing FDA requirements and the many US companies want to start moving toward complying with the EU regulations to be certain their global studies are globally compliant.

Preparing an NDA, BLA, MAA, or PMA always takes longer than expected, and should be started earlier than most drug developers anticipate. For more information, visit Synterteract’s Dossier SubmissionReady Set Submit” page or Medical Writing page, see Part I of this blog or contact us today. 

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