EOM 1352: Fri 7 June 2024, 11:36
Catalyst 7 July 2023, 14:52

Current Edition

Discovery Park: Wed 13 November 2024, 10:35
ramusmedical

Good Review Process – The New Panacea

Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have gotten more streamlined. Which is a good thing, considering the goal of this endeavour is to get new drugs out to patients who need them as quickly as possible. Yet there is one area that has seen very little progress during that time: the review process by which teams of co-authors review and comment on drafts of a document.

The industry as a whole is striving to reduce the time needed to complete the regulatory documents we prepare. Statistics show that, on average, it takes about 8 weeks to prepare a clinical study report, ranging up to 33 weeks. Many people are looking to technology to make a dent in these times. However, technology can only really help reduce time on the first step of drafting an initial draft of any document. What it cannot do is replace the cycles of review and crafting of the text that we humans do to develop the storyline and ensure the focus is on the right data. Unfortunately, that is where most of the blood, sweat, and tears are spent on preparing these reports. A survey of members of the European Medical Writers Association found that the average time spent on review cycles is about 60% of the total time required to complete a clinical study report and can be as high as 73%. Although crafting a document depends on team discussion and it is an iterative process to refine the thoughts of interpreting the data, much of that 73% is due to inefficiencies.

So why is this process so inefficient? The review process has many different areas that need to work for it to run efficiently and many of these are often not done properly. There are 5 key problem areas with the review process: a lack of focus and strategic input, poor prioritisation, revisiting previously agreed sections, comments that are late or unfocused, and too many reviewers. The good news is that these are all problems of poor process and/or a lack of understanding on the part of the reviewers about how to provide meaningful feedback. Through some best practices, reviews can be streamlined considerably by helping the reviewers understand how to avoid these problems.

Like with most things in life, doing something well begins with understanding what you are meant to do. How many people who are reviewing these regulatory documents ever have any training on what a good review looks like? Very few. In the absence of a clear concept of how to do something, most humans will fall back on how they have seen something similar done elsewhere and try to mimic that. So, what kind of role models do we have for providing feedback on documents we write? Generally, these are our school teachers and our parents who corrected things we wrote while at school. What did they do when they checked our documents? They got a big red pen and circled all the spelling mistakes and corrected all the commas. So that seems like the obvious thing to do when we provide feedback on these documents.

Yet, this could not be further from the mark of what is needed. The reason we have documents reviewed by teams of people is because different people see different things and bring a different background and perspective to what we are reporting. We also want to get input from each functional area (clinical, statistics, regulatory, safety, etc) on their area of expertise. What we need from these subject matter experts is their specialised input on content related to a particular topic. Their time is precious and their insight is valuable. When we already have a mechanism in place to ensure grammar and spelling are corrected, these specialists should not be spending their time correcting those things, but rather the area for which only they can provide input.

Catalyst: Fri 8 November 2024, 14:16
Biosynth: Wed 13 November 2024, 10:18