9 Strategies to Increase Enrollment in Clinical Trials
Whether by slowing cognitive decline in patients with early Alzheimer’s disease or exploring genetic therapies to treat sickle cell disease, clinical trials have produced life-saving medical research in recent years.
These breakthroughs, though, can be compromised when clinical trials struggle to recruit eligible patients or meet enrollment targets. Few potentially eligible patients will participate in clinical research if the right clinical trial participants are not recruited.
These struggles are commonplace in translational research, making it more difficult for research teams to produce actionable, data-driven conclusions. Indeed, approximately 80% of clinical trials fail to meet their initial patient enrollment targets.
If successful recruitment strategies are not implemented, broader patient populations will continue to await the life-changing insights of clinical and translational science.
It’s clear that successful patient enrollment is crucial to running successful randomized clinical trials. But how should contract research organizations (CROs) and research coordinators adjust their recruitment and enrollment process to find potential participants?
Here are nine effective strategies to consider when asking how to increase enrollment in clinical trials.
The Critical Role of Participant Enrollment in Clinical Trials
Clinical trials are only as good as they produce results that lead to meaningful clinical research as the participants enroll. Studies that fail to enroll sufficient numbers of patients who meet specific eligibility criteria will struggle to collect enough data.
This effectively unleashes a cascade of negative consequences for a trial. Difficulties with patient recruitment efforts will result in missed deadlines, prolonged delays, and swelling budgets.
By some estimates, (insufficient) patient recruitment is the biggest cause of delays during clinical trials, leading to lost revenue of as much as $8 million daily.
Trials that produce imperfect results while operating on elongated timelines will also struggle to enroll sufficient numbers of viable research participants in the future. And so the downward cycle will continue.
This makes successful enrollment strategies that can boost clinical trial participation all the more important, not only for each study but also for the future of relevant areas of clinical research.
Of course, the consequences of decreased quality in clinical trials go well beyond those borne by the CROs or sites themselves. By their very nature, clinical trials seek to address medical problems and to create new drugs.
Clinical trials that fail to enroll viable participants—succumbing to delays or even failing to move forward entirely—remain unable to produce vital research for future patients.
Best practices during the patient recruitment process are not only practical and efficient, but they are also part of an ethical approach to patient care overall.
Common Challenges in Clinical Trial Recruitment
While patient recruitment is a pivotal stage in any clinical trial, it’s also a process marked by many common challenges. Each of these is a threat to the potential future of a clinical trial, so CROs need to foresee any barriers to enrollment well before they become problematic.
Common issues may include:
- Lack of awareness: Patients who do not understand what’s been asked of them or who to contact with questions or concerns will be more likely to disengage from and even drop out of a clinical trial.
- Mistrust in medical research or healthcare systems: Patients treated poorly by healthcare providers, organizations, or researchers are significantly more likely to mistrust medical interventions, such as clinical trials.
- Logistical or financial challenges: Participation in clinical trials may require patients to take time off from work, pay for childcare, travel far from home, or undertake other additional hardships.
- Limited or insufficient diversity among participants: Many of the above factors exclude certain patient populations, ultimately affecting the diversity and validity of a trial’s participant base.
Each barrier is common and may arise due to entirely natural circumstances—not malicious intent. However, they can negatively affect the data produced by a clinical trial.
Innovative strategies at the recruitment stage must be used to predict, address, and resolve these issues.
Strategies to Increase Enrollment in Clinical Trials
Research coordinators should leverage certain tools as they consider increasing enrollment in clinical trials. Here, we look closely at nine proven strategies to strengthen and enhance a clinical trial at early enrollment.
1. Design Patient-Centric Recruitment Campaigns
Ultimately, patients may disengage from clinical trials for many of the underlying reasons addressed above. However, one way to strengthen their investment in the clinical research at hand is to create a recruitment campaign that resonates with them from the very earliest stages.
Sites and CROs may consider a variety of tactical approaches, including:
- Use plain language in promotional materials.
- Be sure to explain a trial’s objectives, procedures, and benefits.
- Include testimonials from past participants that build trust and credibility.
- Anticipate potential pain points or barriers, addressing them early on.
- Work closely with providers and other partners whom patients already trust.
- Simplify the process of collecting electronic health records with HIPAA-compliant technology to reduce enrollment friction and delays.
Patient retention will result from thoughtful recruitment, which will consider what really motivates, worries, or inspires potential participants.
2. Leverage Digital Marketing
It’s an obvious but crucial point: Potential participants cannot elect to join a clinical trial if they aren’t aware that it exists! That’s why sophisticated marketing that targets specific patient populations is so important at the recruitment stage.
Research teams should consider how social media advertising campaigns—among other digital strategies—can benefit their approach. Social channels enable trial organizers to more easily reach patients of a particular age, racial group, gender identity, geographical location, or medical history.
Clinical trial marketing that understands its audience and meets them where they (digitally) are will be more likely to attract potential research participants.
Alongside social strategies, search engine optimization (SEO) drives traffic to clinical trial websites, helping participants find them via common search engines. However, what participants find is equally important once they arrive at a website.
Mobile-friendly landing pages that address potential participants using clear language and messages that conclude with compelling calls to action will be more likely to reach their intended audience and achieve the desired engagement.
Research coordinators must always know clinical trial advertising guidelines and best practices when developing these strategies. Marketing materials should be accurate and truthful and follow the medical cornerstone of informed consent.
3. Collaborate With Community Organizations
Patient trust begins well before a clinical trial is underway. CROs should form partnerships with local healthcare providers, advocacy groups, and other trusted leaders or groups within patient communities.
Whether it’s meeting potential patients at a health fair or describing a trial’s goals through a webinar or workshop, there are many different avenues to speak to patients or approach them from within their communities. However, these avenues may run through someone else—such as a doctor, community organizer, or faith leader—whom they already trust.
Underrepresented populations are often underrepresented due to environmental or societal factors. A thoughtful approach will be required to combat these oversights, biases, and hesitancies.
4. Implement Decentralized Trial Models
One aspect of a tailored approach may be decentralizing certain elements or stages of the trial. Building in options, such as remote participation or telehealth appointments, and communicating these during recruitment may attract a wider pool of trial participants.
Telehealth participation can also reduce certain financial and logistical barriers for participants who would otherwise be unable to take part in a trial due to travel, commuting, scheduling, or other concerns.
Decentralized trial models also facilitate an accessible, patient-centric approach. They make reaching, recruiting, and retaining patients from rural or other underserved and underrepresented populations easier.
5. Provide Financial and Logistical Support
CROs and sites should strive to be aware of their patients’ basic financial realities. Barriers to access, both to clinical trial commitments and to medical care more generally, may include:
- The cost of travel, whether public transit fees or fuel expenses
- The need to take time off from work, often unpaid
- The needs of children or dependents, including care or supervision
Clinical trials seeking to recruit a diverse patient population should communicate how they will help patients mitigate or resolve these problems during the early recruitment stages.
Research teams can offer travel reimbursements, childcare stipends, scheduling flexibility, or any additional support that makes it clear to patients that their needs will be addressed.
6. Build Trust Through Transparency
In certain respects, building patient trust in a clinical trial’s methods and objectives is the most valuable task during the recruitment phase. Clear, honest communication can alleviate participant concerns early on, giving them a sense of ownership and investment in the trial’s work.
This communication may include:
- Frank discussion of risks and potential drawbacks
- Exploration of benefits and goals
- Clear statements of participant rights and responsibilities
- Different options for contacting CROs with questions or concerns
- FAQs that anticipate patient questions about their protections
- Thoughtful approach to accessibility concerns at every stage
- Providing a systematic review of relevant research
In all patient-facing materials, CROs should include contact information for patient liaisons, trial coordinators, and other administrators who can answer patient questions.
7. Use Data-Driven Approaches
Research teams should remain flexible and adaptive, learning from what works and implementing it in future trials. Data and analytics tools can be used to identify recruitment trends or gather information about common barriers and how to overcome them.
Successful digital patient recruitment will use these tools to calibrate and adjust recruitment approaches in real-time. Real-time campaign metrics can be used in various ways, including:
- Proprietary algorithms target prospects on social media, collecting data on browser behavior.
- Potential participants, once identified, see targeted advertisements via search engines or social media platforms.
- Patients who engage with advertisements are funneled toward online pre-screening questionnaires.
- Prospective participants who pass initial screenings are contacted by Patient Engagement Specialists or other members of a trial’s research team.
A successful data-driven approach involves constantly gathering information about potential patients and adjusting marketing approaches based on this information.
8. Engage Healthcare Providers
Drawing clinical trial participants from the pool of healthcare providers’ existing patients is an efficient and clear-cut way to fold trust and credibility into the entire recruitment process.
Patients are more likely to trust medical authority figures with whom they already have strong relationships, and their providers can serve as essential links between clinical trials and their participants.
Each early aspect of a clinical trial should be designed with research participants and healthcare providers in mind, from digital marketing materials to training guides or other clinical updates and communications.
Strong and open communication with clinics, doctors, nurses, and hospitals is important for each clinical trial and building credibility for CROs in the future. This will lead to more patient referrals and stronger recruitment processes.
9. Prioritize Diversity and Inclusion
Although efforts to address disparities in modern medicine continue, marginalized racial, ethnic, and gender groups are commonly underrepresented in clinical trials. Because a lack of diversity among trial participants leads to less useful research results, CROs should work early and often to address these inequities.
Recruitment strategies that foster diversity and inclusion may involve:
- Providing multilingual promotional materials
- Designing outreach campaigns that approach diverse communities
- Partnering with advocacy organizations already established in communities
- Employing a diverse workforce well-versed in potential barriers and issues
When a trial’s results reveal a lack of participant diversity, it may be too late to fix the problem. Clinical trials considering these questions during the recruitment phase are more likely to produce valid, actionable medical data.
How to Increase Enrollment in Clinical Trials: AutoCruitment
Smarter, more effective clinical trial enrollment begins with more strategic patient recruitment. A decentralized, patient-centric approach to patient recruitment will ultimately produce more diverse trial participants who are more likely to engage with the trial.
And that means more viable, useful clinical research results.
Are you interested in learning more about how these strategies can enhance the potential of your clinical trials? Contact AutoCruitment today to learn more about our patient recruitment solutions.
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AutoCruitment’s patient recruitment platform supports Sponsors, CRO Partners and Research Sites by decreasing time, risk and cost to bring new therapies to market.