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Medical Writing & Submissions Part I: Your Top Questions Answered

Medical Writing & Submissions Part I: Your Top Questions Answered
20 February 2019

Medical writing is critical to clearly articulate the safety and efficacy of potential new drugs to help bring them to market. It is essential in preparing NDA, BLA, MAA, and PMA submissions; however, with numerous other functions involved in clinical trials, medical writing may be an overlooked or underestimated contributor. 

Tony Womack began his career in medical writing in 1997 and today oversees the medical writing department at Synteract. We sat down with him recently regarding answers to the most common questions on medical writing that he receives. This is Part I of a two-part series on the top medical writing questions he gets asked. 

Q: What are some common pitfalls when it comes to medical writing? What should sponsors be aware of?
A: Often clients may ask a CRO how many writers on staff have written Clinical Study Reports (CSRs) on a particular indication. While that information is important, the overall experience of the writer in drafting CSRs, NDAs, or whatever you need done, is most critical. A good writer can write on any indication, whether or not he/she has written on it before. At Synteract we are especially well-versed in medical writing on our five key Centers of Development—in dermatology, oncology, neuro degenerative, pediatrics, and rare and orphan disease—but that doesn’t mean we can’t write a stellar CSR on an atypical antipsychotic.

Q: When should a sponsor engage with a CRO on medical writing?
A: Medical writing should start to be engaged from the day the sponsor hires the CRO. Not necessarily to start writing drafts, but to attend certain meetings. If writers are not brought in until the very end of a study, they have no context. They know what decisions were made, and they have the data results in front of them, but not the “why.” The “why” is where the story really lives. 

Q: What is the difference between a good and a great study report? And do you agree that good writing is important to the success of a clinical trial?
A: Yes, I do agree. Where a great writer can make a difference is as a key team member specifically tasked with looking closely at every phase of the trial. Medical writers have one of the few roles that has an overarching view of everything that goes on in a study. They must be able to write a long, complex document containing all the salient study details while resolving or explaining potential inconsistencies. And in this way they tell the story the way it should be told. 

Often this vantage point gives writers the ability to unearth real issues. As one example, we were running five different studies each offset by a couple of months for a single sponsor. While writing the  first clinical study report we discovered inconsistencies with the data that would not be seen in a casual reading. Everyone thought it was an anomaly, but a similar problem popped up in the next CSR. We stopped data processing, put three or four databases on hold, gathered the right people in a room, and figured out what was going on. The problem was very subtle to spot, but because the writer was able to notice something that didn’t look right we were able to find it and fix it, ultimately saving the client enormous amounts of time and effort.

Q: What types of documents does your team most often write?
A: CSRs and protocols are our “bread and butter,” along with clinical sections of NDAs, informed consents, SAE narratives, and Development Safety Update Reports. 

Q: How long does it take to write a CSR?
A: CSRs, required for submitting all marketing applications, needs to balance brevity with clarity. You don’t want a CSR to be 450 pages long, but rather it should be about 125 pages to capture critical elements of what happened during the study and the study results without including every data point.            

Generally, the more closely sponsors and CROs work together, the better the outcome. For the most part, it takes Synteract 20 working days from receipt of final tables, listings, figures (TLFs) to first draft CSR. Typically, another two weeks after that to finalize and another week or two to publish, depending on timely feedback from the sponsor.

Q: Why can’t we just do an abbreviated report?
A: It is acceptable for sponsors to submit an abbreviated report, but only under tightly defined circumstances. Since the rules on abbreviated reports are very strict, most sponsors prefer to invest the little bit of extra time and expense necessary for a full CSR rather than risk running afoul of the regulatory bodies. 

For example, The U.S. Department of Health and Human Services Food and Drug Administration describes when an abbreviated report may be acceptable in its Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications:

“Abbreviated reports should be submitted for studies that are not intended to contribute to the evaluation of product effectiveness or provide definitive information on clinical pharmacology, but about which the reviewer needs sufficient information to determine that the study results do not, in fact, cast doubt on the effectiveness claims or the description of the clinical pharmacology. Abbreviated reports should contain all the safety information included in a full report.”

Most commonly an abbreviated CSR may make sense when a sponsor is ending development of a compound and needs only the safety information from the trial in their files.

Additionally, the difference between a full CSR and an abbreviated CSR is usually less than a 25% difference in cost. Abbreviated CSRs need to include 100% of the safety data gathered and all other information, other than efficacy, that is found in a full CSR. Finally, with the need to ensure that there is nothing in the efficacy results in the study data that contradicts any submissions already made to the FDA, it is often easier to include the produce a full CSR and be certain.

Check back for Part II of this blog for more on the top medical writing questions or visit Synteract’s Dossier SubmissionReady Set Submit” page or Medical Writing page or contact us for more information.

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