Empowering patients through more accessible clinical trial information

“Only 5% of eligible patients ever take part in a clinical trial.”

An eye-catching statistic, and one that’s often repeated in the literature. But we’re starting to realise that the full picture is much more complex¹ — it may actually be as low as 3% for some cancer clinical trials². A recent study found that the vast majority of people agree that clinical research is generally safe, and very important to develop new medicines, but fewer than 1 in 3 people are really willing to take part in a trial³. So, what’s causing this gap? In many cases, it’s the lack of appropriate, patient-facing information.  

Despite all the attention that the COVID-19 pandemic brought to clinical research, many people still have no knowledge about trials and how they run⁴. Healthcare professionals (HCPs) are patients’ most common source for clinical trial information³,  and most people would consider taking part if their doctor or nurse recommended it⁵. But, in reality, HCPs rarely discuss clinical trials with patients, and refer very few³. Workload plays into this, but it may also be that HCPs are making judgment calls on behalf of their patients. This narrows the participation funnel before some patients even hear about trials. It also feeds into the issue of those who do take part being “passive subjects” — lacking agency, autonomy, and, in some cases, the ability to truly consent.

It’s very clear that we need to do more to bridge the knowledge gap between patients and their HCPs. There’s high demand to make it easier for the public to learn about clinical trials⁶. And we know that activated patients, who take a leading role in their own health, are better at self-managing their conditions and staying adherent to treatment⁷.Activated patients could make for better trial participants. But how do we get the relevant information out to patients, to better inform and empower them, and help them self-refer? Activated patients could make for better trial participants. But how do we get the relevant information out to patients, to better inform and empower them, and help them self-refer?  

Aiming for higher-level societal engagement between pharma and communities should be the ultimate goal, to improve health literacy, build trust in the industry, and increase trial awareness. We know this will need a mindset shift and long-term planning, but there’s lots we can do at a smaller scale, in the meantime. One realistic target is to evolve the online information that’s available to patients.  

Online registries like clinicaltrials.gov are a cornerstone of public-facing trial information, proving essential to improve transparency and address reporting biases⁸. In theory, they’re the ideal place for patients to learn independently about a trial’s purpose, eligibility criteria, design, and ethical oversight. Continuous improvements to registries and initiatives from independent organisations. In theory, they’re the ideal place for patients to learn independently about a trial’s purpose, eligibility criteria, design, and ethical oversight. Continuous improvements to registries (centerwatch, ct.gov) and initiatives from independent organisations (NIHR) are making it easier for patients to learn about clinical research in general, and find relevant trials. However, finding a trial is just the start. Low health literacy among the general public is still a real concern (NIHR), so even those patients who can find specific trials may not understand the details. As an industry, we’re also starting to recognise more about the questions and concerns patients have. Issues like:  

• The impact of participation on current treatments⁶ 
• Costs of taking part⁶
• The likelihood of being assigned to a placebo arm⁹
• Concerns with the trial setting¹⁰ and other logistical factors⁶
• Fear of the impact on their relationship with their regular doctor¹¹‍
• The burden of tests and assessments¹¹

Obviously, the onus is on those who register the trials and post the listings to make sure the information is useable and useful for patients, and written in language they understand. Unfortunately, despite increased focus from the US Food and Drug Administration (FDA) and European Medical Commission (EMC) on publicly accessible clinical trial information, compliance has been low, and the quality of listings is extremely variable. A recent review found that listings are often incomplete or lack Plain Language descriptions, especially when it comes to trial design, eligibility criteria, and details about placebos. Even across trial listings from the same sponsor, there are many inconsistencies¹². Up to 1 in 5 online trial listings have unknown recruitment statuses⁸. And, most importantly, patients report that the trial information they’re presented with does not meet their needs¹³.  

Really, what we need is commitment from across the industry towards consistent, high-quality trial listings. This is not a case of punishing non-compliance — it’s about making sure research teams have the right support, resources, and training to deliver. Help them look past the short-term burden of extra work, towards the benefits of more accessible information for all. Many pharma companies are also moving towards their own, bespoke trial directories as part of direct-to-patient solutions. This is the ideal opportunity to take a fresh approach: work with patients and advocacy groups to define the “need to know”, establish the right lexicon and tone of voice, and make use of other forms of media to support all types of learners.  

Let’s keep pushing to make online clinical trial information truly publicly accessible, so we can empower patients to take an active role in their own care.

1. Getz k., Appl Clin Trials 32(3), 2023. Available here.
2. Kumar G. et al., Contemp Clin Trials Commun 28, 2022. Available here.
3. Anderson A. et al., JAMA Netw Open 1(6), 2018. Available here.
4. Yadav S. et al., Clin Med, 2022 DOI: Available here. DOI: https://doi.org/10.7861/clinmed.2022-0107. Accessed 01/05/2024.
5. Wells K. et al., Patient Edu and Couns 88(2), 2012. Available here.
6. Wahlstrom-Edwards L. Appl Clin Trials 28(3), 2019. Available here.
7. Hibbard J. Patient Edu and Couns 100(1), 2017. Available here.
8. Gresham G. et al.,Trials, 23(858), 2022. Available here. DOI: 10.1186/s13063-022-06569-2. Accessed 01/05/2024.
9. Fogel D., Contemp Clin Trials Commun, 11(156-164). Available here. DOI: 10.1016/j.conctc.2018.08.001. Accessed 01/05/2024.
10. Mills E. et al., Lancet Oncol 7(2), 2006. Available here. DOI: 10.1016/S1470-2045(06)70576-9. Accessed 01/05/2024.
11. Moorcraft S. et al., Trials 17(17), 2016. Available here. DOI: 10.1186/s13063-015-1105-3. Accessed 01/05/2024
12. Moore E. Appl Clin Trials, 2022. Available here.
13. Schindler T. et al., PLoS One 15(5), 2020. Available here. DOI: 10.1371/journal.pone.0233294. Accessed 01/05/2024.

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