Clinical trials fail for many different reasons. We also have to distinguish between clinical trials that are conducted to receive FDA approval and clinical trials that are conducted to show the efficacy and safety of an over-the-counter consumer product. For this article, we will focus on consumer brands.
The #1 concern
“What if I don’t get the results I want” is one question I get a lot when talking to consumer brands about clinical trials; usually followed by a “do I get my money back?”. This question tells me that the founder or employee of the company is actually not convinced that their product works, which is a red flag for me and my team. Citruslabs is a digital CRO (contract research organization). As such, we are supporting your brand to conduct your clinical trial, from start to finish. We don’t guarantee positive trial results. We are an independent group that is testing your product and in the best case, your product does what you promise and gives consumers a positive result. If your product doesn’t work, then it is on you and your team to make it better.
Without further ado, here are the main reasons why clinical trials fail (consumer brand version):
1. Study design
The CRO (contract research organization) can design your clinical studies for you. However, sponsors (a sponsor is a company that is paying for the trial, in this case, a brand) can also decide to design their clinical trials themselves, which happens also frequently.
We have seen study design going horribly wrong specifically when sponsors (the brands) design the studies themselves. The issue usually lies in study design that is too complex. While complex studies are not at all an issue, sponsors have to stay realistic on a) timeline, and b) budget. Want a randomized placebo-controlled trial with 250 participants, 3 blood draws over 3 months, and additional monthly digital biomarkers per participant? You better have a large budget and some time. We see studies fail because sponsors have only 6 months’ time for a large, complex study that would usually take 12-18 months. In the end, sponsors are frustrated because their expectations are out of whack, patients are frustrated, and your CRO is frustrated because it has to pick up the pieces.
What you can do about it? Trust your CRO! Especially when your CRO consults you on study design, take their feedback into consideration. Most brands don’t have a lot of experience with conducting clinical trials. If your CRO tells you that your study design is too complex to be conducted as a virtual study and that this is a design for a site-based study, they are probably right. If your CRO tells you that your timeline expectation is too ambitious, they’re probably right. If your CRO tells you that your study inclusion and exclusion criteria are too strict, they’re probably right as well. Remember: the CRO is in your corner, their whole goal is that you succeed.
Here are the major obstacles when designing your clinical trial:
Virtual vs. site-based vs. hybrid - which is the right approach for you?
Single group vs. randomized-controlled study vs. placebo-controlled study - what is the right design for you? Think about your budget, your company maturity, and the claims you’d like to get out of the study.
Study population & group size(s) - how large does the clinical trial need to be?
Inclusion and exclusion criteria - what characteristics should the study participants have?
Biomarker - do you want to get bloodwork done? Do you want to measure digital biomarkers like blood pressure, weight, etc.?
Logistics - who is packing and shipping? Do you need a placebo?
Each of these above bullet points could fill a blog post in itself and I will likely write about it at a later stage.
2. Patient Recruitment
This is a big one that is heavily intertwined with study design. Patient recruitment is oftentimes the #1 reason why clinical trials fail. They usually fail because the inclusion and exclusion criteria are too complex so that a huge part of the population is excluded from the study. Especially if sponsors are looking to receive results fast, a long list of inclusions and exclusions doesn’t help. Think about your study population in detail. Especially because the harder it is to recruit patients, the more expensive it will be for you and the slower the process will be. Think also of patient compensation: the higher it is, the more patients will be willing to participate in your study. Here are some keywords to think about:
Study size - how many participants do you really need to get the results you want?
Inclusion and exclusion criteria - how strict should they be?
Compensation - how much do you pay study participants?
3. Participant retention
Interestingly, patient retention is often overlooked as a reason why clinical trials fail. Probably because everybody is so focused on the recruitment part. Currently, about ⅓ of participants drop out of any given clinical trial for several reasons. One reason why participants drop out goes again back to study design: when the study is too complex, and the participants have to do a lot (for example: get blood draws, complete several surveys; complete study diaries; etc.) they are more likely to drop out, especially when the compensation is more on the lower end. Or, if you’d like to get bloodwork from the participants, do you make it easy for them and provide at-home fingerprick tests, or do participants have to go somewhere to get their blood drawn? This is what you need to think about:
# of participant touchpoints - how do you keep participants engaged?
Compensation - how much are your paying participants?
Study tasks - what do you expect participants to do?
Accessibility - can participants stay in the comfort of their own home to complete the study or do they have to go somewhere else?
4. Product failure
Clinical trials can also fail because of a product that doesn’t work. This doesn’t mean that the clinical trial was poorly designed or managed, it just means that the product doesn’t work, and therefore, the clinical trial failed. There is nothing really you can do about this type of failure, except, redesigning the product. Oftentimes, clinical trials are also used for exactly this: finding evidence that the product works or doesn’t work. In this case, it probably wouldn’t be seen as a “failure”, but rather as an opportunity to learn and to further develop the product.
In the past, we have seen this specifically with technology products (devices and apps), especially when sponsors wanted to accelerate the speed of their clinical trials to meet certain deadlines for market launches, conferences, or anything else. After we distributed the products, we received many complaints from participants that the products don’t work - the tech broke. We kept most participants engaged and in the study for over 6 months (for studies that should have ended after 6-12 weeks) and completed the studies for the sponsors despite tech issues. Here is what you need to watch out for:
Does the technology of my product work?
If my product doesn’t show efficacy - is this a failure or an opportunity to learn and improve?
How to mitigate clinical trial failure
To promote the success of your clinical trial, it is important that you hire an experienced project manager for your study. This project manager can be somebody internal, such as a Chief Medical Officer, or a VP of Research; or, it can be somebody external, such as a CRO (contract research organization). Oftentimes, in-house project managers work with CROs to ensure a smooth implementation of the clinical trial.
Especially when working with an external CRO, or consultant, make sure that they don’t inflate or deflate the complexity of the study you need to create your marketing claims. Because, in the end, study design makes or breaks clinical trials and is also responsible for budget and timeline.
If you’d like to speak about your clinical trial with us, you can contact us here.