Once a new medical intervention is approved for human clinical trials, the task of recruiting participants can commence. However, this can often be challenging, with approximately 85% of trials failing to recruit enough patients, and 80% being delayed.
There are several strategies you can adopt to enhance the recruitment process and make it effective, whilst ensuring a diverse section of the population is represented.
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The importance of choosing the right clinical trial recruitment strategy
An effective clinical trial recruitment strategy is vital for ensuring the success and validity of any research study. By choosing the most suitable volunteers, Contract Research Organizations (CRO) and sponsors can gather accurate data that’s representative of the target population – and diversity among clinical trial participants is a critical part of this.
Challenges in clinical trial recruitment
Clinical trial recruitment represents several challenges, ranging from a lack of eligible participants through to psychological barriers that prevent people from wanting to take part. However, understanding what your issues are can help you identify your approach, or how it may need to change.
Low participant awareness and interest
A lack of public awareness and interest in clinical trials can make attracting volunteers very difficult, and if recruitment targets aren’t met, the study can’t go ahead. This can sometimes be due to a lack of funding, which makes clinical trial advertising and awareness-raising challenging.
Strict inclusion and exclusion criteria
Many studies adhere to strict inclusion and exclusion criteria in order to standardize participant characteristics and gain accurate data. However, this can limit the number of eligible volunteers, and even exclude marginalized populations. For example, cancer trials often exclude people of African descent due to them having naturally lower counts of a certain type of white blood cell.
Lack of physician referrals
Some physicians fail to refer suitable patients for clinical trials due to being busy and overworked, or because they don’t know which study is the most appropriate for their patient. They may also perceive the risks as being too great, and as such, choose not to tell them.
Geographical barriers
Often people find it difficult to physically access clinical trials for assessments and follow-ups, particularly if they have limited mobility and the studies are taking place in inaccessible academic centers. People in rural areas may also find it challenging to attend trials in urban areas, and vice-versa.
Patient burden
Complex procedures, frequent visits, lost work time, treatments costs, and lifestyle changes are all inconveniences that can arise from clinical trials. These patient burdens can deter people from taking part in studies that could potentially improve their condition.
Lack of realistic goals
Some trials have an over-ambitious vision of how many participants they can recruit within their funding and schedule restrictions. As such, setting unrealistic targets can prevent the predetermined number of volunteers from taking part, which means the trial can’t go ahead.
Small participant pools
If the study is focusing on a rare disease, or has very specific protocols for a different reason, the pool of potential participants might be small. This means fewer people are eligible to volunteer, making recruitment difficult.
14 patient recruitment strategies for clinical trials
In the past, clinical trials relied heavily on referrals from healthcare providers, as well as community outreach, and printed media advertising. In fact, the Center for Information and Study on Clinical Research Participation suggests that 64% of people think they should hear about clinical research from their primary care provider, but only 0.2% of overall participants do.
However, a wide range of other strategies are available, and using a combination of methods usually results in better recruitment and greater diversity.
1. Understand your patient population
By developing a patient-focused protocol, you can design your study with the participant
in mind, and avoid any unnecessary burdens. This will ensure they feel supported and understood, so you can attract and retain more volunteers. This begins by understanding your target market, which might involve in-depth conversations (either face-to-face or virtually) to gain a deeper level of knowledge about their needs and preferences.
2. Inform healthcare providers about your trial
Medical referrals shouldn’t be discounted as they still have the potential to recruit participants whilst saving on costs. Many patients have a trusted relationship with their primary caregiver, and therefore, would prefer to hear about trials directly from them. However, you can increase the likelihood of a referral by clearly communicating with the physician about who is eligible, how it can benefit patients, and the potential benefits and risks of taking part in a clinical trial.
3. Connect with nonprofit partners and patient advocates
Many nonprofit partners and patient advocacy groups have a direct line to potential recruits, and can create a supportive environment for patient participation. By collaborating with them, they may promote your trial for free – although if they ask for a fee, the return on investments is typically high as the outreach is so targeted. Plus, because these groups are connected with people from all types of background, you can reach a more diverse population.
4. Deploy digital recruitment campaigns
Digital advertising significantly extends your reach, so you can attract and recruit far more people. This can include online advertising, organic keyword targeting, search engine marketing, and pay-per-click campaigns that ensure your study is easy to find. However, it’s important to follow FDA guidelines, and check for potential keyword restrictions.
5. Utilize social media advertising
In addition to the digital advertising mentioned above, social media is an effective method of engaging with large numbers of people, as well as reaching a diverse population. Consider platforms such as Instagram, TikTok, and Facebook, which usually enable you to target people based on key demographics such as age, gender, and location, as well as their interests.
6. Work with a patient-centric clinical trial recruitment company
Some companies specialize in patient-centric recruitment and can develop a strategic outreach plan which makes recruiting the right participants more effective and easier to manage. When deciding which clinical trial recruitment company to choose, finding out how well they know the patient population, how they communicate with participants, and whether they’re connected with advocacy groups can help you select the best option for your needs.
7. Contact patients who are already interested in trials
By screening the eligibility and suitability of individuals who have previously expressed an interest in clinical trials, you can save a lot of valuable time and money. Healthcare providers and patient groups may already hold this information, as will clinical trial recruitment companies.
8. Screen for multiple trials at a time
Clinical trial sponsors often undertake several trials within the same condition area, so simultaneously selecting participants for them all can save time and costs. You may also be able to keep their records on file to enhance recruitment to future trials.
9. Take advantage of artificial intelligence (AI) and other technologies
AI can accelerate the recruitment process by reading vast datasets and identifying eligible clinical trial candidates, saving significant time and staffing resources. Chatbots can also provide potential participants with real-time answers to queries, while AI-powered sentiment analysis tools can monitor online platforms for participant feedback, so any issues can quickly be addressed.
10. Use patient follow-up services
It’s important to keep interested participants engaged and informed about trials so they remember to sign up and take part. This might involve email and digital marketing, or postal reminders for more elderly patients.
11. Broaden inclusion and exclusion criteria
As previously mentioned, many research studies have very specific inclusion and exclusion criteria, which can limit eligible volunteers and sometimes exclude minority populations.
However, this presents an opportunity for biopharma companies to design specialized trials that examine the unique biomarker variations in these other populations, and ultimately, create and test more targeted therapies. It also encourages more diverse recruitment.
12. Remove geographical barriers to boost the participant pool
Widening the search location for participants can be beneficial, as can partnering with organizations with a diverse community outreach, or using local community hubs within target populations.
If the geographical location of the trial is a barrier to diverse participation, researchers could consider moving the trial to a more accessible location for underrepresented populations. They may also choose to conduct a decentralized clinical trial which allows people to take part virtually, or via a hybrid model.
13. Keep patient retention top of mind
Strategically, it is advisable to consider recruitment and retention simultaneously to prevent drop-out at later stages. You can encourage retention by ensuring clear and consistent communication throughout the process.
This includes reminding participants of their requirements and upcoming appointments, sharing updates about the study’s progress, checking-in to be sure the patients are having a positive experience, and reminding them about the many benefits of taking part.
14. Provide incentives
It’s common to use incentives as a method of attracting and recruiting participants to clinical trials. As well as financial compensation, they might include vouchers, gift cards, or tokens of appreciation, as well as enhanced medical care, and access to innovative new treatments.
Other clinical trial recruitment considerations
While you’re deciding which approaches to use, you should also use data-driven insights to think about the target population, the research site, and your investigator selection strategy to ensure they all align.
Factors to consider for clinical trial site selection
When you're looking at potential trial sites, ensure they’re situated in areas with access to a large pool of eligible and diverse participants. Analyzing medical claims, prescription and other healthcare data can help you pinpoint suitable locations. Sites situated close to hospitals and clinics will also improve accessibility for patients.
The site will also need to contain the resources you need, so check it has the correct equipment, facilities, data management capabilities, and personnel to support a successful trial.
Factors to consider for investigator selection
Utilize physician data to choose investigators with a thorough understanding of the condition being treated, and select individuals with previous clinical trial expertise to accelerate the approval process. Ideally, they will also have connections with other practitioners who can refer potential patients.
Conclusion
Effective clinical trial patient recruitment strategies can help identify and enroll more participants from a wider cross-section of the community – so you can avoid costly delays, save time and resources, and enroll a diverse pool of participants.
We’ve successfully matched over 10,000 patients with clinical trials, leveraging our large community of willing participants, our partner community outreach, and our experience in IRB-approved targeted advertising. Find out more about how we enroll participants onto clinical trials.