During clinical trials, interviews with participants can provide a wealth of clinical research data which is often overlooked. These interviews can provide key pieces of evidence when determining whether a trial has been a success or whether it is moving in the right direction.
But this can be an overwhelming task for researchers, especially in Phases 2 and 3 of a trial where, arguably, the best qualitative data is collected. Both of these phases rely on a large number of participants (running into the thousands in Phase 3) and the trial may be split over several sites. In order for the collected data to be useful, researchers must find a way of standardising patient interviews and logging responses in a way that benefits the trial itself.
Let's take a look at why and how participant interviews should take place during clinical trials.
Well, simply put, interviewing participants can add value to a clinical trial. They give the chance for the participant to express their thoughts on the trial and provide evidence which may not be immediately obvious from the typical questionnaires made for trials.
In addition, more and more regulatory bodies, such as the FDA in the US or the MHRA in the UK are showing increased interest in this type of qualitative data. Understanding the patient experience with new drugs and therapies is extremely important.
After all, these are the intended end users and first-hand experience can give valuable insight into the effectiveness of the treatment.
Interviews can be held at any time before, during or after a clinical trial, depending on the type of data sought by the researchers.
Pre-trial interviews, for example, will give more info on the symptoms experienced by the participant before the trial begins, their severity and impact on daily life. This type of trial will also establish the participant’s expectations for the trial, which, alongside the exit interview, will give valuable insight into the positive effect the new treatment has had on their life.
Interviews conducted during the trial will reveal information on how the administration of the treatment affects the participant’s life, whether it is easy to administer the drugs and maintain the regular treatment schedule or whether there are any side-effects and how manageable they are.
These interviews will also give valuable insight into how the treatment is positively or adversely affecting the participant’s quality of life and whether they are actually noticing the changes that are taking place in their health.
Exit interviews will show the levels of satisfaction with the treatment and give an overall view on how the treatment period has affected them. Comparing these results with the expectations discussed in the pre-trial interview can be extremely illuminating.
Ok, we’re sure that by now you can see the advantages of conducting these interviews, they provide high quality data which is supremely useful for evidencing the results of clinical trials.
But that doesn’t mean they are easy to conduct. As we mentioned in the first section of this article, there are certain barriers in place which can make this process difficult. The sheer number of participants would make it a mammoth task to interview everyone involved in the trial.
One way to get around this might be to conduct interviews with a smaller sample of participants. Researchers may choose to concentrate on the initial Phase 1 cohorts or take a random sample from later stages.
Another problem is that the trial may not be confined to one institution and instead be spread around several hospitals all over the country. The biggest problem here is that, in all likelihood, there will be several people conducting the interviewers. If this is the case, how do you prevent subjectivity and bias?
Well, this is where video analysis can come into play.
The use of video analysis software such as Codimg can ensure objectivity and cohesion when collecting data from participant interviews. Here’s how:
The camera doesn’t lie, right? Filming interviews ensures that the information gleaned is not filtered through the bias of the observer. Responses are there on film and the footage provides proof of EXACTLY what was said.
This means that there is no bias creeping in from the interviewer and, as long as the questions and structure of the interview have been set beforehand, the video will give a true representation of the responses.
The same cannot be said of written reports where the information comes second hand and without all the supplementary means of communication such as body language and emotion.
Ok, let’s give a quick overview of how video analysis software actually works…
An interview is filmed and, either during the event itself or retrospectively, the observer tags the video when they hear something relevant. This creates a short video clip which, when compiled with all the other video clips at the end of the interview, gives a succinct summary of the interview without all the inevitable waffle, which is normal in these types of situations.
In Codimg, the tagging process is done with a button template which is created entirely by the user to include any information they wish. This template can then be shared around everyone that will be conducting the interviews. Again, this ensures objectivity and standardisation across the board.
As we have said, a Codimg template is completely customisable, but here's an example of what such a template might look like for clinical trial interviews:
As you can see, we have sections which are dedicated to the experience of the participant, the result of taking the drug, plus a rating of these results, and a section for possible expected side effects.
Of course, Codimg isn’t just a video editor, it’s designed for video analysis.
As well as adding video clips to a database, data about every click will also be added. This makes it easy to find the pertinent info very easily. Want to see all the video clips relating to side-effects and, specifically pain in the right arm? Use the Codimg data matrix to find all of the moments when participants discuss this. All the relevant info is there at a click of a button, saving researchers from having to wade through multiple interviews and hours of footage.
The information contained in the tags can also be used to produce quantitative data. Want to know how many participants have experienced the alleviation of pain during the trial? There are multiple ways you can do this. First of all, the Codimg dashboard is a powerful tool which transforms tags into easy to read charts and graphs. Choose the parameters you want to compare and create a pie chart or line graph.
Numerical data can also be exported to Excel where it can then be, for example, imported into third-party data visualisation tools such as Power Bi or tableau.
Codimg makes data analysis easy.
There is much more to Codimg than we have mentioned above. It is completely adaptable to the needs of the user and, in the case of clinical trials, could be applied to many more steps in the process. In fact, any process which can be filmed can be improved with video analysis.
If you we’ve piqued your interest and think that Codimg could be useful in your clinical trial, saving both time and money, get in contact with us for a chat about your needs and we’ll set you up with a free trial and talk you through your needs.
If you’re not involved in clinical research but have nevertheless found this article interesting and have any questions or would like more info, contact us through our website or on any of our social media channels. We love to talk!
✔ Cohort interviews are an extremely important part of clinical trials, providing essential insights into the process.
✔ Interviews can be held at any time during the trials.
✔ In larger trials, a small sample of participants is sufficient.
✔ Analysis software such as Codimg can help obtain objective evidence quickly and efficiently.
Thanks for reading!
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