Non-compliance in clinical trials of retinal studies report a significant loss-to-follow up on patient numbers

Research from a retrospective analysis of 10 randomized clinical trials reporting on 390 subjects in investigator-initiated trials found  178 participants (45.6%) were noncompliant, while 212 participants (54.4%) were compliant. Analysis  of the  study indicated that regression models identified 17 variables that were significant in determining subject noncompliance. A number of these variables included distance (from travel), comorbidities, diabetic status, concomitant medications, previous clinic visits, length of study, disease under study, and severe adverse events.  The investigator-initiated trials included nAMD, proliferative diabetic retinopathy (PDR), and retinal venous occlusive diseases (RVO).

 

From FDA statistics across all types of pivotal studies, the cost of a mean study was estimated at $19M per trial, after which just under a tenth of all such trials lead to a therapeutic regulatory approval.  While there are of course multiple reasons for trials not to complete such studies, one includes a loss-to-follow-ups (LTFU), which can then lead to under-powered studies.  The research has stated that “noncompliance during prospective studies can bias results and limit conclusions.”  One independent study had estimated that “a study initially powered at 90% could have an actual power of 50% to 87% depending on the percentage of subjects (40% to 5%, respectively) contributing noninformative data owing to noncompliance to study procedures.”

 

In the study, subjects recorded noncompliance issues such as worsening health (18.9%), death (15.1%), no longer wishing to participate in the study (13.2%), adverse event (AE) occurrence (9.43%), work (5.66%), relocation (5.66%), or transportation problems (1.89%), with over 30% subjects being lost to follow-up without documented explanation owing to termination of contact, despite multiple attempts to maintain contact.  In the study, noncompliance rates decreased significantly with increasing age, with a rate of 58.7% for subjects aged <60 years, 45.7% for subjects aged 60 to 74.5 years, and 32.3% for subjects aged >75 years.  In their discussion, the report had commented that “retina research has suffered many setbacks, with 3 failed phase 3 trial programs in 2018 for either nAMD or geographic atrophy secondary to AMD.”  The study highlighted that in sponsored studies of HAWK and HARRIER, there was mean completion rates of 89.5% and 93.4%, respectively.  Similarly, in RISE and RIDE, there was mean completion rates of 83.3% and 84.6%, respectively, and VISTA and VIVID had mean completion rates of 76.6% and 74.4%, respectively.  Further review may need to be required to show more specific details between investigator-initiated studies compared to commercial sponsored clinical research studies.

339 thoughts on “Non-compliance in clinical trials of retinal studies report a significant loss-to-follow up on patient numbers”

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  127. You have made some decent points there. I checked on the web for more information about the issue and found most people will go along with your views on this site.

  128. Aw, this was an incredibly nice post. Taking a few minutes and actual effort to produce a good article… but what can I say… I hesitate a whole lot and don’t seem to get anything done.

  129. I must thank you for the efforts you have put in penning this website. I am hoping to check out the same high-grade blog posts by you in the future as well. In truth, your creative writing abilities has inspired me to get my own, personal website now 😉

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  131. Greetings! Very useful advice in this particular post! It’s the little changes that will make the most significant changes. Thanks a lot for sharing!

  132. Howdy! This article could not be written much better! Looking through this post reminds me of my previous roommate! He constantly kept preaching about this. I most certainly will send this information to him. Fairly certain he’s going to have a very good read. I appreciate you for sharing!

  133. The next time I read a blog, Hopefully it does not fail me just as much as this one. After all, I know it was my choice to read through, nonetheless I really believed you’d have something interesting to talk about. All I hear is a bunch of complaining about something that you could fix if you were not too busy seeking attention.

  134. Aw, this was an actually great blog post. In suggestion I would love to place in composing such as this furthermore? taking time and also actual initiative to make a great post? yet what can I say? I postpone alot and also never appear to obtain something done.

  135. I have to thank you for the efforts you’ve put in writing this site. I’m hoping to view the same high-grade blog posts from you in the future as well. In truth, your creative writing abilities has inspired me to get my own, personal blog now 😉

  136. Can I simply say what a relief to uncover someone that actually knows what they are discussing on the web. You definitely realize how to bring an issue to light and make it important. A lot more people need to read this and understand this side of your story. I was surprised that you aren’t more popular since you surely have the gift.

  137. Aw, this was an extremely good post. Taking a few minutes and actual effort to make a very good article… but what can I say… I procrastinate a lot and don’t manage to get nearly anything done.

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  139. I needed to thank you for this very good read!! I absolutely enjoyed every little bit of it. I have you bookmarked to check out new things you post…

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  142. Saving our environment is very important and a priority for all of us. The setting is one thing that everyone has a component to play in preserving. Environment is essentially the most important aspect of the human race and we have a duty to preserve it. So, to save nature, we should defend it and to protect the surroundings we should be taught in regards to the significance and fragility of our environment.

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  145. Right here is the perfect webpage for anyone who would like to find out about this topic. You understand a whole lot its almost tough to argue with you (not that I really would want to…HaHa). You certainly put a fresh spin on a topic that has been discussed for many years. Excellent stuff, just excellent!

  146. I’m amazed, I must say. Rarely do I encounter a blog that’s equally educative and amusing, and let me tell you, you’ve hit the nail on the head. The issue is something that not enough folks are speaking intelligently about. I’m very happy that I stumbled across this during my hunt for something concerning this.

  147. An impressive share! I have just forwarded this onto a friend who had been conducting a little research on this. And he actually bought me breakfast simply because I discovered it for him… lol. So let me reword this…. Thank YOU for the meal!! But yeah, thanx for spending time to discuss this subject here on your blog.

  148. I absolutely love your website.. Very nice colors & theme. Did you make this site yourself? Please reply back as I’m wanting to create my own personal website and want to learn where you got this from or what the theme is named. Thanks!

  149. Nice post. I learn something totally new and challenging on websites I stumbleupon every day. It’s always interesting to read through articles from other authors and practice a little something from other web sites.

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  153. When I originally commented I clicked the -Notify me when new remarks are added- checkbox and currently each time a comment is added I get 4 e-mails with the very same remark. Is there any way you can remove me from that solution? Thanks!

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  158. Have you ever considered publishing an e-book or guest authoring on other sites?
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  159. I know this if off topic but I’m looking into starting my
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