Clinical trial patient recruitment and retention practices have significantly advanced over the last 15 years thanks to technological innovations and the rise of AI, shifting patient expectations and the increased, and much-needed, spotlight on diversity and inclusion. At the same time however, clinical trial patient recruitment remains as challenging as ever. At Innovative Trials, we have spent every day of the last 15 years supporting our clients to accelerate patient access to life-changing treatments through our best-in-class clinical trial patient recruitment and retention support. Now in our quindecennial year of business, Hayley Tilley, one of our Associate Directors, joined Leanne Woehlke, Executive Vice President of Soglia, a division of Entrada, and LaQuinta Jernigan, Senior Vice President of Business Development at Monroe Biomedical Research, to look back at the challenges and opportunities that have shaped, and continue to influence, clinical trial patient recruitment, discuss strategies to optimize enrollment, and set a vision for the industry. 

Major clinical trial patient recruitment challenges

Advancing our understanding of medical conditions and the ongoing cycle of developing cutting-edge medicines are essential to improving and maintaining our global health. But drug development is rarely a smooth and easy process, and clinical trial patient recruitment and retention has, and continues to be, one of the biggest hurdles sponsors face in getting their treatments to market. 

Key challenges include: 

  1. Diversity and inclusion. Increasing diversity among clinical trial participants has been a decades-long challenge for the pharmaceutical industry. 
  2. SARS-CoV-2. The COVID-19 pandemic may have led to greater public awareness of clinical trials, but it also caused a break in the drug development pipeline – which is still arguably being felt today – and increased patient concern about clinical research.
  3. Distrust and anti-science sentiment. Distrust in the pharmaceutical industry has existed for many years, but became more pronounced during the pandemic. This is a growing concern with some people actively sharing anti-science rhetoric and misinformation on social media. 
  4. Technology over-reliance. The growth of digital technology has opened new avenues for clinical trial patient recruitment, but it also comes with challenges. There is a risk that those who are unable to get online or are not used to digital devices could be left behind, exacerbating the diversity and inclusion challenge further.
  5. Artificial intelligence (AI). AI offers exciting possibilities for streamlining recruitment, but it is not without its issues. Maintaining ethical standards is key and pivotal to this will be extensive oversight to ensure data accuracy and quality, maintain data integrity and reduce the risk of bias. 
  6. Professional burnout. Many clinical research sites carry a large administrative burden and often struggle to find the time to execute all their tasks effectively. We know staff can find it difficult to manage workload, risking burnout. 

Strategies to boost clinical trial patient recruitment

Embed empathy into all clinical trial patient recruitment activity

The golden thread running throughout the discussion between Hayley, LaQuinta and Leanne was the importance of empathy in clinical trial patient recruitment and retention. Empathy is a gateway to building trust and establishing meaningful relationships with patients because it allows them to feel heard, respected and valued. “…when [patients] feel informed and we’re communicating in an empathetic way that touches that at the core of who they are, then they know they can trust us…People want to feel heard. They want to feel valued.” – Leanne Woehlke 

Actively listening to patients’ concerns, addressing their questions with care, and acknowledging their unique experiences can go a long way towards breaking down enrollment barriers. This human-centered approach both enhances patient engagement and ensures recruitment efforts are inclusive and respectful, ultimately leading to better outcomes.

Patient education to demystify clinical research

In this online age, more channels than ever allow information to be shared widely and quickly. Sadly, not all information is accurate. Sometimes it can be deliberately misleading. This rise of dis- and mis-information has fuelled public cynicism. Combined with the fact that clinical research has always been somewhat shrouded by a veil of obscurity to the general population, it can be difficult to gain people’s trust and help them understand what clinical trials are and why they are so important. Raising public awareness about clinical trials and tackling online dis- and mis-information is essential for long-term recruitment success. Investing in educational campaigns and initiatives, on- and off-line, and collaborating with patient advocacy groups will help demystify clinical research and support patients and their families and caregivers to make informed decisions.

 “I think now, more than ever, there’s an increasing need for transparency and probably most importantly, patient education around trials generally, but probably also specifically for the individual studies that procedures that are involved and the commitment needed, and importantly, how…their data is used.” – Hayley Tilley

Invest in community outreach to increase diversity

One of the most pressing challenges for clinical trial patient recruitment continues to be the underrepresentation of diverse populations in clinical trials. As we all know, diversity will help ensure that clinical trial data reflects the real-world population for that particular treatment. This helps to inform dosage recommendations and understand potential side-effects. There is no quick fix to solving the challenge of diversity in clinical trial patient recruitment; the barriers to participation are, in many cases, ingrained and longstanding. However, in-country and boots-on-the-ground efforts remain some of the most effective ways to engage diverse patient populations. Sponsors should prioritize building relationships with local organizations and advocacy groups, especially those who work with and are based in underrepresented communities. 

 “We need to make sure that there are trusted voices out there in communities to increase diversity…but it’s something that’s going to take outreach and working with various organizations to accomplish…” – LaQuinta Jordan

 Consider building and embedding a diversity plan into trial protocols from the start. This will enable clarity of thinking and ensure efforts are being utilized effectively in the right places. But sponsors must also be aware that patient diversity in clinical trials is a ‘long game’; invest in ongoing and long-term engagement initiatives.

Leverage digital technology strategically

Technology plays an increasingly significant role in modern clinical trial patient recruitment strategies. Digital advertising campaigns can target and reach specific demographics to increase the pool of potential study participants. Meanwhile, AI offers exciting possibilities for improving trial accessibility and streamlining recruitment, making digital solutions attractive and cost-effective options for sponsors and sites. And wearable tech makes health monitoring easier and more convenient for people. But there is a darker side to such technology – an over-reliance can ultimately make recruitment harder, not easier, as it risks widening the ‘digital divide’. Not everyone has the financial or physical means to access the internet or online-connected devices. Others may not possess the necessary knowledge to navigate or use online platforms or advanced technology. Keep trials accessible by combining traditional recruitment methods with innovative technologies. Ensuring no person is left behind will inevitably promote inclusion and contribute to a more positive relationship between patient and site.

 “We need to be raising study awareness in the places where our potential patients are going to be, and so, if that means social media or other digital advertising places [then that is] where we need to be…[but] we can’t use those to an extent that we alienate individuals that aren’t comfortable in those spaces or don’t have access or don’t trust those places.” – Hayley Tilley

Support research sites to avoid burnout

Burnout is a very real concern in healthcare. Research shows healthcare professionals can be prone to it due to the intense nature of their jobs, and we know clinical trial support staff can also experience symptoms, such as extreme emotional exhaustion. Sites are very often time and resource poor yet their workload remains high. It can be an impossible juggle. For patients, it can reduce the quality of care or attention they receive, for site staff, it can impact their mental and physical health, and for sponsors, it can result in sometimes lengthy delays. To avoid burnout, it’s crucial sponsors recognise this issue and put in place additional support. Invest in technology (and the necessary training) that can help streamline operations, commission pre-screening services, fund community awareness events and provide resources for patients so that sites don’t have to create their own.

 “I think we all agree we need to be where the patients are. We need to remove some of the burden off the study sites…[to] let the sites do what’s really great. Get out, do those community events, meet those patients that have previously been underrepresented and not invited to the clinical trial table…” – Leanne Woehlke 

A future vision for clinical trial patient recruitment

So, what is the future for clinical trial patient recruitment? At Innovative Trials, we believe in a ‘blended’ approach. Technology and AI have the potential to streamline processes, reduce site burden and make clinical trials more inclusive and accessible, but this will mean nothing without the ‘human touch’. Empathy will remain a key element of patient engagement, and its authenticity lies in human relationships. Local, in-country community outreach, and patient and site support will always be much more effective at tackling public distrust and dismantling barriers to participation than remote or digital initiatives.

“For me, anything that supports the sites, that reduces their burden, that makes clinical trials more accessible for patients…more interesting for patients, safer for them [is important].” – Hayley Tilley

We are also committed to educating patients, their families and caregivers, and the wider public where we can, about clinical trials. Making sure potential study participants and their loved ones have the knowledge they need to make informed decisions based on accurate and truthful information is crucial to successful clinical trial patient recruitment and retention.

“In 15 years from now, when we’re talking about this, [I want us to be] saying, ‘Wow, look how far we’ve come. Look how easier…it is to recruit because of the educational programmes we’ve put in place.’” – LaQuinta Jordan

 For 15 years, we have been at the forefront of clinical trial patient recruitment and retention, and are the only such company to provide in-country support to 70-plus countries, benefiting sponsors, sites and patients. Find out more about how our work is helping accelerate patient access to potentially life-changing new treatments.