Overcome clinical trial hurdles in drug development. The rate of failure is a staggering 90%, making clinical trials a risky endeavour for sponsors. Comprehensive risk management is critical if a trial is to succeed, and this can involve planning to fail: considering possible scenarios that may lead to the trial being delayed or stopped, and figuring out how to deal with them before they happen.
In this blog post, we look at some of the issues that might impede progress in your trial, and how you can overcome them.
Efficacy, safety and operational issues: top reasons for failure
Looking at clinical trial failures in 2025, there are some clear factors at play. Among late-stage clinical trials, failure was frequently due to the trial missing its primary endpoint or key secondary outcome, and for adverse events and side effects. Overcoming these issues in late-stage clinical trials requires intervention in earlier stages, making the development process more efficient.
At all phases of clinical research, operational issues like financial and technological difficulties can be significant barriers to success. Assessing the risk of these issues and planning to mitigate that risk is a critical element of effective trial planning and management.
Here we’ll dive into a few of the biggest factors to consider when planning to fail: study design, recruitment and technology.
Study design: avoiding rigidity
Sponsors planning clinical research need to make big decisions early on, including what the trial will look like. The gold standard – the randomized controlled trial (RCT) – might not always be the most appropriate option.
Although they are robust, RCTs can be inflexible, making it hard to adapt to challenges as they occur. Wrongly choosing an RCT design could lead to failure at any stage of the trial.
Sponsors can benefit from considering alternative trial designs, such as point-of-care studies, which also support patient centricity (a key requirement for effective recruitment and retention, as we’ll see in the next section).
Adaptability is also supported by other trial types, such as platform and umbrella trials, which test multiple interventions for a single disease, and basket trials, which test a single intervention for various diseases.
- Top tip: Partner with a CRO like Siron Clinical early on in the clinical trial development process, to benefit from the study design expertise and experience of CRAs who have worked across many different trial types.
Recruitment: anticipating barriers
According to research, as much as 86% of clinical trials do not meet their targets for recruitment, and 10% of oncology trials are halted early due to safety and recruitment problems. In previous articles, we have explored the importance of patient centricity in clinical trials, including related to technology.
What can go wrong when it comes to recruitment? Failure to involve patients in the research process from the beginning can mean lower patient centricity, leading to recruitment issues down the line. A lack of planning for diversity and representation can mean imbalance in enrollment and lower engagement. And choosing technology that suits your trial design but not the patients can cause problems with recruitment and retention.
As well as posing a risk, technology can also boost recruitment. For example, sponsors can consider AI for predictive patient recruitment.
- Top tip: Work with a CRO to connect with patients from the start, through patient groups and associations, to maximize the success of your recruitment strategy.
Digital technology: ensuring support
In clinical trials, the use of digital technology has expanded far beyond the eTMF, and sponsors are now faced with the choice of various platforms for communication, data collection and analysis, project management and more.
Decentralized clinical trials (DCTs) grew strongly during the COVID-19 pandemic and these approaches have remained an important element of clinical research today. However, DCT approaches risk having the opposite effect than what is intended, potentially isolating participants rather than engaging them.
More recently, AI has emerged as a tool used across the clinical trial process, from design to publication. AI has been shown to be useful in predicting outcomes, streamlining processes and even synthesising data to fill knowledge gaps. But AI brings its own risks, including privacy concerns and reliability.
With clarity around the risks digital technology, including AI, can bring to the trial, sponsors can set out to design a package of tools and platforms that are fit for purpose and suit the patients at the heart of the research.
Top tip: Talk to your CRO about how you can leverage AI across your clinical trial while minimizing risk.
If all else fails: publish your data anyway
One of the big problems in the clinical research ecosystem today is the lack of transparency and communication that leads to wasted resources. Specifically, medical publishing favors positive results, making it less likely for negative results to be published.
The impact of this is significant: time, money and resources are often wasted researching an intervention that has already been shown to be ineffective, because the results were never made available. Trial registration is helping reduce this redundancy, but there is still a huge gap in published negative results. As a sponsor, you have the opportunity to build the knowledge base and help others avoid failure in the future by publishing all your results – whether positive or negative.
At Siron Clinical, we understand the ingredients for success in clinical trials, and we know how to anticipate failure and mitigate risk. You can access our expertise on your terms through our customizable FSP – find out more here.
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