Eloise Moffatt, our Vice President of Commercial, joined other industry experts during a webinar about AI trends and technologies for 2025. They discussed the benefits that AI and machine learning (ML) can bring to clinical trials and the potential pitfalls that require careful consideration.
Four ways AI can boost clinical trial patient recruitment and retention
Expedited data analysis for faster clinical trial patient recruitment
Clinical trial patient recruitment remains one of the largest challenges in the drug development process. It is widely recognized that more than 4 in 5 studies still fail to meet their patient enrollment deadlines. Delays like this can be extremely costly for sponsors. AI has the potential to mitigate this risk; algorithms can analyze vast quantities of data quickly, including electronic health records (EHRs), digital health data and even social media activity, to identify eligible patients faster and more accurately.
“We can use AI to comb through part of the electronic health records to really be able to get a clear answer…we’re able to really use the technology to examine even unstructured data so we can get a clear idea of which patients are qualifying.” – Leanne Woehlke, Executive Vice President of Soglia
Facilitating greater diversity and inclusion in clinical trial patient recruitment
Diverse patient representation in clinical trials is vital to ensure medicines are safe and effective for everyone who needs them, but such inclusivity in clinical trials has been historically lacking. This is an issue close to our heart; Innovative Trials has been actively working since its inception to dismantle the numerous barriers that can prevent people from underrepresented communities from getting involved in clinical trials. This includes the work we do to increase diversity for our clients as well as our whitepapers and call for a national policy to mandate diversity reporting in clinical trials.
During the webinar, the group spoke about how AI can help boost traditional diversity and inclusion initiatives. Social media companies, for example, have been using algorithms for several years to analyze people’s behaviour and feed them content they are most likely to be interested in. For clinical trial patient recruitment, data analytics supplied by the same social media companies can help identify underrepresented populations. This can help companies refine their approach to audience targeting and tailor their digital outreach strategies accordingly. Other techniques, such as AI-driven translation for fast and cost-efficient content localization and AI-powered sentiment analyses to ensure culturally adapted messaging, can also help to elevate clinical trial patient recruitment campaigns by dismantling language barriers and improving inclusivity.
“We run often online digital marketing campaigns…but we do this in 25 plus countries [and this] is a challenge from a content perspective…we figured out in one country that video formats [where] an influencer just records themselves and speaks to the patient is highly effective… and that means huge cost savings. Now, when you can [work with] a medical influencer in one country, that’s nice, but how do you roll this out to like 10 to 15 countries?…we can use AI tools that translate the video from that influencer [into another language]…For example, in Poland, we did this where we have a German influencer, she records this in German, we AI translate this to Polish and then we run this video in Poland.” – Tobias Kruse, Managing Director for Europe at SubjectWell
Reducing the burden on site staff and trial coordinators
Clinical research sites are under pressure like never before. In addition to a bulging drug development pipeline, which was exacerbated by the impact of the COVID-19 pandemic and which the industry is still working through, there is a workforce shortage of clinical research professionals1. According to the Society for Clinical Research Sites (SCRS), the turnover rate of patient-facing staff could be as high as 61%2. This puts added pressure on those who remain in post. Addressing this issue of staff turnover is obviously important, but AI can at least contribute to easing the burden on existing trial coordinators. Site management solutions that automate workflows, predict potential recruitment challenges, and reduce the overall administrative load will inevitably optimize the clinical trial process. Not only will this benefit site staff but patients too.
“if we only have one study coordinator and it’s going to take her four days to get back to a patient…that’s where we really try to support the coordinator [to] optimize their workflow so that they’re able to reach out to the patients that are most likely to enter a trial and reduce the burden, right? We should be reducing friction for the coordinators, increasing opportunity for the patients, and really looking to optimize wherever we can.” – Leanne Woehlke
Enhancing patient engagement and retention
For many clinical trials, patient retention can be a challenge. There can be many reasons why a patient may drop out of a study, such as non-adherence to the treatment, side effects, changes to their health or personal circumstances and inconveniences or challenges associated with follow-up appointments. A lack of engagement with site staff may also be a factor, leaving them feeling undervalued. But effective and consistent engagement takes time and effort, luxuries that research staff often do not have. AI-driven chatbots, virtual assistants, and predictive analytics have the potential to help reduce pressure on site staff while at the same time improving the patient experience. When programmed correctly, they can provide real-time responses to patient queries, personalized trial information and appointment reminders. AI can also play a part in developing and translating materials so that patients and their families and carers have access to information that addresses their most pertinent questions in a way they can easily understand.
“I believe we are still misunderstanding a lot what patients are expecting…I can see virtual assistants, chatbots, things like that, to be developed for really supporting patients and caregivers….AI is developing very fast.” – Julie Powell, Corporate Development Director for Pleco Therapeutics
Potential AI pitfalls and how to overcome them
Despite AI’s advantages, and there are several, challenges currently still remain with the technology’s adoption in clinical trials.
Accuracy and reliability concerns
AI will only ever be as good as the data it is trained on. If this information is incomplete, inaccurate or biased in some way, the results will not be robust or trustworthy. With clinical trial patient recruitment, this risks inaccurate patient matches or eligible participants being overlooked, including those from diverse communities.
It is imperative to consider data quality and relevance to optimize AI-powered clinical trial patient recruitment. Data may need reviewing, cleaning and labeling to ensure it is fit for purpose before enrollment begins.
“…if you’re training [AI] on information on the internet, you’re only training it based on those people. If you’re training AI based on bullets of medical records, you’re only training it based on people that are in that database, so there’s some percentage of people that, for example, are maybe not seeing a regular physician or seeing an alternative practitioner and that data is not going to represent those individuals, so you run the risk of actually introducing more bias. So, we want to be careful about how are we training the data? We also want to make sure that we’re not excluding those who perhaps aren’t tech friendly.” – Leanne Woehlke
Regulatory and ethical considerations
The regulatory landscape for AI in clinical trials is evolving, with increasing scrutiny on data privacy and patient confidentiality. Several countries are developing national frameworks and governance for AI while the European Union has already published and begun implementing the EU AI Act.
Understanding the global landscape and legal frameworks within each country is crucial when considering the use of AI in clinical trial patient recruitment and retention. In addition to these overarching regulations, major technology companies like Meta are tightening up their own requirements for health-related digital advertising, which could impact enrollment strategies.
“…everything gets much more expensive and harder to do, especially in patient recruitment, and that’s just like one thing right now, where, where I see a certain, certain tension between, ‘Hey, AI is a very good tool, it helps us,’ but then on the other hand, regulation gets way more restrictive, and then takes a little bit away of the thunder from from the new AI tools that are being released.” – Tobias Kruse
Lack of training or integration within existing workflows
For site staff already struggling with their workloads, there is a possibility that AI could be seen as an initial hindrance; one more thing to learn when their to-do lists are already overflowing. It may add to a feeling of ‘technological fatigue’ due to the number of digital tools now available to support organizational processes and workflow. Clinical trial sites must ensure that any AI solution is seamlessly integrated into existing operations and lives up to the promise of increasing efficiencies and making people’s working lives easier. At the same time, all staff need dedicated time to ensure adequate training, but Eloise cautions that thought should be given to how different cultures perceive AI as not everyone will necessarily want to use it in the same way or at all.
“If AI is a tool that can be used right at the beginning, [site staff] can obviously be coached on using that AI tool, so that takes away that fear [of new technology] straight away….It can also help with…cultural understanding, because we just assume that every single country and every culture is going to be accepting of AI…if I think of Japan as an example, how we work with the Japanese sites is very different to every other, so again, we’ll have that kind of different thought process of how we’ll work with AI in different countries.” – Eloise Moffatt, Vice President of Commercial for Innovative Trials
Balancing AI and human interaction
In an era where AI is becoming increasingly integrated into clinical trials, maintaining the human element and empathetic touch is more important than ever. AI technologies have the ability to increase efficiencies, accelerate timelines and generate cost savings, but patients still value human connection, especially when making critical healthcare decisions. AI should complement, not replace, the personal interactions between study coordinators, investigators, and patients.
“I do not believe that AI will replace people. I think patients and caregivers really need this contact, this human touch, to have the empathy and to be heard.” – Julie Powell, Corporate Development Director for Pleco Therapeutics Services like Innovative Trials’ Patient Support Center ensure that while technology advances, the essential human connection remains at the forefront of patient care.
“I think that there can be a balance of trying to improve efficiency, but then we also need to make sure that we are still having those conversations, you know, and especially when there’s a frustration and there’s a lack of knowledge from potential participants of enrollment in a trial. Obviously, we talk about this day in, day out, but there’s a lot of people that have been freshly diagnosed, are only just learning about clinical trial space and clinical trials…They want to speak to someone.” – Eloise Moffatt
Innovative Trials is committed to supporting sites and sponsors to accelerate patient access to new and potentially life-changing treatments. We know that no two studies are the same, which is why we implement clinical trial patient recruitment and retention strategies that best fit each study’s needs. This includes 1:1 in-country recruitment coaching and site support, bespoke educational materials, targeted digital campaigns and our Patient Support Center.
Thank you to Antonio Drea, a director at TransPerfect, for hosting the webinar. Our VP, Eloise, spoke alongside Leanne Woehlke, Executive Vice President of Soglia, a division of Entrada, Tobias Kruse, Managing Director for Europe at SubjectWell, and Julie Powell, Corporate Development Director for Pleco Therapeutics.
References
- Freel, S. A., Snyder, D. C., Bastarache, K., Jones, C. T., Marchant, M. B., Rowley, L. A., Sonstein, S. A., Lipworth, K. M., & Landis, S. P. (2023). Now is the time to fix the clinical research workforce crisis. Clinical Trials, 20(5), 457–462. https://doi.org/10.1177/17407745231177885
- Society for Clinical Research Sites. (2023, January 12). Open letter to sponsor and CRO colleagues regarding the workforce retention and inflationary pressures affecting clinical trial sites – Society for Clinical Research Sites. https://myscrs.org/workforce-challenges-letter/