Every drug has its core clinical papers, and usually a set of ‘less important but maybe useful/interesting’ ones that need to be assessed. For a copywriter, this often means that, at least at the outset of a project, you are faced with a ring-binder full of papers to work your way through. So it goes without saying, that a good scanning technique is a vital tool to be able to get a quick grasp of the strength and breadth of data supporting a particular drug.
This is how I go about it, but there are no doubt other, equally valid approaches.
As an example, for the purposes of writing this article, I have used a study that was published in 2014 here. The study looked at real-world clinical outcomes in multiple sclerosis patients in order to ascertain the ‘value’ of treating with disease-modifying-drugs (DMDs) – either immunomodulatory (IM) or immunosuppressant (IS).
Step 1 – establish the broad credibility and veracity of the study
1.1 Go right to the end and check to see if there were any commercial sponsors: that may nuance slightly the veracity of the data – and the word ‘nuance’ is important here as I am not suggesting that company-sponsored studies are any less rigorous than non-sponsored trials! But it can sometimes be thrown back at you as an objection, so it’s important to be aware of it.
1.2 Where was it published? Is it an obscure journal or more mainstream? This is important because most authors would love their studies to be published in high profile, respected medical journals, but of course that depends on the ‘strength’ of the study. In this case, the Multiple Sclerosis Journal is a credible, disease-specific publication that is endorsed by leading MS research groups such as ECTRIMS and ACTRIMS.
You can also search for the Impact Factor of the journal which will provide you with a measure of its importance or rank based on the frequency its articles are cited. In the case of the MSJ, its impact factor of 5.649 places it in the top 7% of all journals – so very respectable, although admittedly not at the dizzy heights of the NEJM or The Lancet.
To find out more about the subject of Impact Factors, just go on-line, where there is a plethora of useful information. It’s an interesting and informative read. Suggestion: search ‘impact factor of medical journals’
Step 2 – what are the headline findings?
2.1 Go straight to the conclusions in the summary on the first page!
That’s right. Don’t delve into any details until you’ve absorbed the main outcome of the study.
In this case, the conclusion signposts that there could be some very useful findings in this study, from the top-line (to paraphrase: “These drugs work!”) to the more subtle (“They still work, but to a lesser extent, if you delay treatment”). That is a very enticing conclusion for a copywriter, because you can be confident that there will be some useful nuggets of data on display further on in the paper.
Step 3 – look at the top line results
3.1 You might have noticed that we still haven’t gone past page 1 yet, but that’s fine. The paragraph relating to Results in the Abstract gives you some strong clues as to how excited you should be about the data within.
In this case, the very first result that is given jumps out at me. The risks of progression to a major disability milestone are reduced by 94% in patients treated with IM drugs compared with untreated patients. That really whets my appetite – I want to know more!
3.2 Look at the statistics. It can’t be avoided – as dry as they are, such a big result that we just mentioned needs to be statistically credible if we are to use it in any promotional sense. So we head to the main results section of the paper – page 3.
Here, at the foot of the right hand column you can immediately see that this seems to be very solid data from a statistical view point.
The CI 95% figures mean that this reduction might ‘only’ have been 91%, but could also have been as high as 96%, and a p value of <0.001 means that there is less than a one in a thousand chance that this result is purely down to chance and not a treatment effect.
See our article ‘Basic Statistics for Marketers’ if you want to delve deeper into the subject – INSERT LINK HERE]
Step 4 – is the patient cohort credible?
Now that we are excited about the data, we need to check that the patient cohort wasn’t skewed in any way, such that a good outcome was inevitable. This is the point where you have to do a little more in-depth reading.
I usually begin by scanning the Patients and Methods section (page 2), but in this case, I found more interesting information at the beginning of the results section. There is one stand-out paragraph:
What I deduce from this is that the study not only contained a good number of patients, but also that, very unusually, they were all living under similar conditions as Sardinians on the same island. To understand the power of this, imagine if it was a cohort of 316 patients spread across the whole of Italy: that would immediately raise suspicions that patients had been specially selected in some way and such a low number would also undermine the credibility of the findings.
Then delving deeper, table 2 on page 5 reveals that the patient numbers for the group my client is interested in (those taking immunomodulatory drugs and EDSS 3 as the milestone) is still very credible: 1306 treated patients vs. 781 untreated.
Note that this particular consideration is sometimes not an issue. In some of the rare diseases we work with, drugs are often trialled in only a handful of patients by necessity
Step 5 – are there any worrying safety signals?
The efficacy data mentioned above are exciting, but that would be easily undermined if in that same cohort of patients there happened to be a high morbidity or mortality impact. In this case, the study was not designed to reveal any safety signals, so there is simply no mention of safety throughout the paper.
You might think this is unusual, and it is, but the immunomodulatory drugs that were included in the study have been on the market a long time, and their safety profiles have been very well defined in many other studies and treatment databases.
Step 6 – Are there any other major caveats?
Sometimes, when reading a clinical paper, it becomes clear that the authors are themselves slightly ‘uneasy’ about reading too much into the findings because of some inherent flaw in the methodology, or data collection etc., and if this is stated strongly, then you have to take notice of it.
In this paper, the authors quite fairly point out that observational studies per se have their drawbacks, but then they do contextualise this in a positive way.
That quick scan of an important clinical study took about 15 minutes, but if done correctly, it tells the copywriter that this paper is worth more detailed investigation, or if it can be dismissed. It’s a useful skill to master for the busy marketer or medic.
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