Clinical trials are a cornerstone of medical innovation, but their success is often challenged by high costs, cumbersome administration, and the difficult task of patient recruitment. In fact, over 80% of clinical trials fail to enroll on time, delaying study progress and costing trial sponsors millions.
Various factors make finding enough qualified patients an uphill battle, from complex eligibility criteria and lack of patient awareness to logistical hurdles and other site burdens. While the challenges of patient recruitment in clinical trials are significant, they are not insurmountable.
So, how do contract research organizations (CROs) and sponsors ensure recruitment success? Let’s explore three clinical trial recruitment strategies that can break down enrollment barriers and speed up time to approval.
Step 1: Do your research before site selection
Failing to meet enrollment targets in clinical trials is a long-standing problem. But what drives the disparity between sites and investigators who excel at patient recruitment and those who fall short? Often, it's a mismatch between the investigator or site selection and eligible patient populations.
Not all researchers and trial sites are created equal when it comes to enrollment capabilities. Some might have limited access to eligible patients, while others may lack the experience or resources to recruit them efficiently. This mismatch between clinical trial sites and the patient pool can result in poor recruitment and delayed timelines.
However, strategic site and investigator selection based on data-driven insights can significantly improve patient recruitment in clinical trials. By leveraging data, clinical trial professionals can pinpoint the fastest recruiting sites and investigators prior to selection. Now, let's dive into the key factors that can make or break a trial’s success before it even begins.
Factors to consider for clinical trial site selection
- Patient volume: Sites taking part in a clinical trial must have access to a high volume of patients meeting eligibility criteria. Medical claims data, prescription data, and other real-world healthcare data can help sponsors and CROs identify sites with a high volume within your target population.
- Resource availability: Ensure the site has resources to adequately support the trial. Evaluate facilities, equipment, personnel (study coordinators, trained investigators), and data management capabilities. Technology installation data can help assess infrastructure adequacy.
- Location matters: Sites close to hospitals, clinics, and diverse communities not only improve accessibility for patients but also tap into a richer pool of potential participants, ultimately boosting your recruitment success.
Factors to consider for investigator selection
- Therapeutic expertise: Seek investigators with deep knowledge of your therapeutic area or disease state. Leverage data platforms that aggregate physician data to identify those with the right expertise.
- Strong referral networks: Look for providers with strong connections to other physicians who can refer potential study participants. Large referral networks are especially crucial for surgical trials, where recruitment can be unpredictable due to the diverse nature of surgical patient populations.
- Clinical trial expertise: Choose investigators with proven research experience, a history of collaborating with sponsors and CROs, and familiarity with trial procedures like informed consent and regulatory submissions. This streamlines the process and can significantly impact speed to approval.
By considering the factors outlined above, you can increase your chances of finding the right partners to drive faster patient recruitment.
Step 2: Market and advertise your clinical trial
You’ve picked your site and partnered with skilled physicians. The next challenge lies in attracting the right patients to your clinical trial. Gone are the days of simple flyers; today, successful recruitment demands a nuanced, multi-channel approach. Traditional media – like subway ads or TV spots – can still play a role, but most people turn to the online world for information. This is where social media and strategic digital marketing become your key allies. Consider these specific tools:
- Search engine marketing: It might make sense to run geo-targeted search engine marketing (SEM) or pay-per-click (PPC) campaigns to ensure patients find your study when they search online. As with any healthcare-related advertising, stay mindful of FDA guidelines and potential restrictions on keywords.
- Social media: Social media is a great way to quickly engage with a wide number of people. Platforms like Facebook offer powerful targeting capabilities, allowing you to target niche patient segments based on their demonstrated interests and key demographic data such as location, age, and gender.
- Propensity models: Propensity models are statistical tools that predict the likelihood of an individual having a specific condition or exhibiting a particular behavior. These models can be used to focus your marketing efforts on the right audiences and channels.
Remember, successful recruitment goes beyond just raising awareness. It's about building trust and transparency. Be upfront about the details, potential risks and benefits, and the commitment involved.
Step 3: Stay engaged with clinical trial participants through regular follow-up
Once you have recruited your participants and your study begins, your work is still not done. Even for trials that get off the ground, patient retention becomes a concern, with an average dropout rate of about 30%. Here are three ways to promote participant retention:
- Ongoing communication: Give your participants the option to receive reminder emails and text messages that tell them when they have upcoming appointments, what to expect, and how to prepare for those appointments.
- Emphasize benefits: Most patients know what the benefits of participating are, but it’s important to continue to remind patients that they need to be enrolled for the full duration of the trial to receive the benefit. This reminder needs to be regularly emphasized throughout the process.
- Share updates and progress: Keep participants informed on the study's progress and highlight their role in advancing medical research. Celebrate major study milestones together.
Increase your chances of clinical trial success with artificial intelligence (AI)
Artificial intelligence (AI) is having a major impact on the world of life sciences and especially clinical trials. Through a combination of machine learning (ML) algorithms, natural language processing, and optical character recognition, AI can quickly read large datasets and identify candidates who meet the trial’s specific criteria.
And studies have shown how much AI is pushing the needle. For example, a study exploring the effect of real-time automated patient screening systems found that the AI tool reduced patient screening time by 34% and increased enrollment by 11%.
The same techniques can also improve patient matching accuracy and speed. Mayo Clinic’s use of IBM’s Watson for clinical trial matching led to an 80% increase in enrollment in clinical trials for breast cancer in the 11 months following implementation. In another study where Watson was used, AI helped to screen and process 90 patients against breast cancer protocols in only 24 minutes, which was a 78% reduction in time compared to the 110 minutes it took for a human coordinator. In a clinical trial studying patients with lung cancer, the AI matching system was able to reliably exclude ineligible patients with about 95% accuracy and identify eligible patients with about 92% accuracy.
Altogether, more accurate and reliable data leads to more effective clinical trials and a better end product.
Learn more
By embracing these three strategies, CROs, trial sponsors, and research sites can work together to overcome recruitment hurdles, unlock the full potential of clinical trials, and deliver the medical breakthroughs that hold the promise of a healthier tomorrow. To learn more about how healthcare commercial intelligence can help you speed up enrollment and deliver trials on time and within budget, sign up for a demo of Definitive Healthcare.