By: G3 Life Sciences Team
Clinical trials are essential for developing new therapeutics, whether medications or medical devices. To ensure that the therapeutics are safe and effective, they must be tested on a wide range of patients. And as we continue to see in the headlines, when patient recruitment is unsuccessful, clinical trials can be compromised and findings nullified. However, finding and recruiting underrepresented patients remains challenging, even for the largest global pharmaceutical companies.
Yet sponsors will need to overcome this challenge, as the newest legislation involving clinical trials is now in place. President Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617) on December 29, 2022. The Food and Drug Omnibus Reform Act of 2022 (FDORA) is included in the act. FDORA includes provisions for promoting diversity in clinical trials. This Act is a long time in the making, and sponsors will need to adhere to these new requirements.
A huge factor in successful trials is finding potential study participants who qualify and are willing to take part in the trial. Unfortunately, with nearly 20% of clinical trials failing to enroll even one participant and a dropout rate of 25%, it’s clear that patient recruitment strategies need to be revised and improved.
To enroll more patients in available clinical trials, sponsors need to evaluate their marketing strategy and look into areas where the patient recruitment process can be improved. In this blog, we’ll explore the clinical trial recruitment challenges faced by clinical operations in the life sciences industry and how a targeted mix of market research, patient insights, and omnichannel marketing can help turn things around.
Three International Clinical Trial Recruitment Challenges
When it comes to international trials, patient recruitment teams face certain additional clinical trial recruitment challenges. For example, language barriers and cultural differences can make recruitment efforts more difficult. In addition, a wide range of legal and regulatory compliance needs to be thoroughly researched and considered when considering multiple international markets. Let’s explore three current challenges in clinical trial patient recruitment and enrollment.
1. Patient Misconceptions
Clinical trials can provide beneficial experiences for patients and the medical community, yet many potential participants remain unaware of the advantages they could gain from enrolling in these studies. Misconceptions about clinical trial participation, such as fear of negative side effects or apprehension about receiving a placebo, can impede enrollment.
To ensure individuals are empowered to make an informed decision, it’s important to invest time into educating them (and their families) about the benefits of selecting your trial over other options and providing clear and concise information that they can understand. Making it as easy as possible for the patient to participate is key.
2. Language Barrier and Communication
It’s essential to understand the culture of the country where a clinical trial is being conducted. For example, if patients within a specific culture view a medicine differently than what is outlined in the study protocol, it will be very difficult to find suitable participants. This concept also applies if the trial is recruiting underrepresented populations from multicultural backgrounds. Ensuring this assessment and understanding its cultural insights are critical to creating an accurate patient profile.
Gaining patient trust in the highly regulated and confidential healthcare industry can be another challenging task. Establishing trust requires clear, literacy-level appropriate communication that is backed by comprehensive research and data. In today’s digital world, providing accurate and reliable content is essential for healthcare providers to build trust with their patients. As a result, medical affairs teams should be particularly mindful of the content they create and disseminate to ensure that their company is seen as a knowledgeable and authoritative industry leader. Trust can be easily lost, so it’s important to tread carefully when navigating this sensitive subject matter. The reputation of your business depends on it.
3. Digitization Concerns
The digitization of healthcare data presents numerous complex challenges. Patient and healthcare information must be highly protected, necessitating that access to the data is strictly regulated and monitored. This can often pose an obstacle to implementing omnichannel campaigns on a global scale.
Perhaps the most pressing issue related to digitizing healthcare data has to do with privacy. Sponsors must ensure that personal data remains secure and confidential to protect the interests of their patients. The security of patient information should be a top priority for any organization dealing with digital healthcare data.
Additionally, understanding potential patients’ digital literacy is key. How comfortable will your target patients be interacting with mobile apps or receiving information about the trial via text or email?
Ensuring Diversity in Clinical Trial Recruitment
While global clinical trial recruitment challenges are associated with marketing clinical trials, if implemented correctly, the results can be incredibly powerful. To drive successful recruitment and engagement, sponsors must create a comprehensive strategy that leverages a variety of channels. Here are six ways to do this.
1. Connect with Patient Advocacy Groups
Connecting with the right patient advocacy groups is a critical aspect of effectively recruiting patients for clinical trials. By connecting with the right groups and attending or advertising at relevant events, you can increase awareness of your open studies, broaden your reach to potential patients, and set yourself up for greater success in meeting your recruitment goals. Community outreach for patient recruitment will ultimately benefit not only your recruitment goals but also the larger community through increased visibility and access to treatments. Through this, you can reach more people and build credible relationships that will help you secure the right participants for your clinical trial.
Support groups for patients and their family members are a great way to provide education, comfort, and strength to those dealing with illnesses or diseases. Through these support groups, individuals are more likely to agree to participate in research studies, as the request is coming from a trusted source. Social channels such as LinkedIn for healthcare professionals or Facebook for patients are also being leveraged to reach potential participants, and it is critical to understand the legality of doing so within the international markets you are considering.
2. Engage Individuals with Content
Content should be targeted to the patient profile you’re trying to reach and include consistent branding across the multiple touchpoints. The assets you create and the language you use should be tailored (localized) for the target patient and not reused across every target audience. For example, images should be as specific as possible to the patient profile, as potential patients should identify with others as part of the study.
In addition, use plain language, a method of writing clearly and simply so that the audience can easily understand the content. Since medical content oftentimes contains dense, complicated content full of medical jargon, it can be hard to understand. Using plain language guidelines in your patient outreach materials makes the content more appealing to readers.
3. Speak Your Audiences’ Language: Inclusion and Digital Accessibility
Communicate with your target audience in the language and method that they prefer. This means translating and localizing your patient recruitment materials, including social media posts, website content, screening questionnaire, and videos. The content should be translated by experienced translators with specific clinical experience.
It also means ensuring that digital content is accessible. Digital accessibility includes things like an accessible website, live and offline closed captioning, and language and sign language interpreters at in-person events.
4. Support Patient Engagement
Research shows that 80% of patients research medical-related questions online. In addition, many US patients do their research after hours—at night and on weekends—and international participants need support during their off-hour times. This means that sponsors should have patient contact center agents available during these hours and time zones to answer questions and support interested participants through the online patient recruitment process. It also means that the support should be in the patient’s preferred language, whether with bilingual agents or over-the-phone interpretation.
5. Improve the Patient Experience
Improving the patient experience should be at the forefront of global patient recruitment. It’s essential for both offline and online patient recruitment and retention, both of which are fundamental for a successful trial. Gathering testimonials from patients who have had positive experiences with the organization is an effective way to showcase the quality of service and patient-centricity being provided.
Social listening is a key way to understand what’s being said online so that sponsors can improve the patient experience. Social listening enables companies to track, analyze, and respond to conversations on social media, and it’s important to track this in multiple languages and multiple platforms.
When it comes to patient-centric recruitment, always ensure that the patient’s needs are prioritized. Consider how they will be accessing the central research location—through a decentralized trial platform, a physical site, or a hybrid approach. What does the patient require to ensure access? Whether it is digital, physical, or a combination of both, providing varied access options will increase the likelihood that patients are willing to take part in the trial. It’s worth investing resources into these initiatives to ensure a successful outcome.
6. Be Open and Transparent
The number of clinical trials has increased in recent years, offering new treatments and the potential for a better quality of life. However, with the complex nature of clinical trials, it’s important to be open and transparent with potential participants. To make this process easier, providing marketing materials that give healthcare providers and patients as much information as possible upfront can help to ease their anxiety and aid in the recruitment process.
Use an FAQ format in various marketing materials, such as brochures and web pages, to answer common questions potential participants may have. This will help to ensure that when they make their decision about joining the trial, they have all the resources they need.
When recruiting well-targeted respondents, it’s important to allow enough time for the process. Depending on the complexity of the recruitment criteria, this could take anywhere from four to six weeks; this timeline is particularly important if low-incidence rate diseases or other particular criteria are involved. Therefore, when planning a research project involving respondent recruitment, ample time should be allocated to ensure that the right participants can be onboarded.
Conclusion
As the industry increasingly shifts toward a more patient-centered focus, sponsors must be willing to invest in their branding and marketing efforts, build relationships with key stakeholders, prioritize the patient experience, and look for prospective participants in the right places. With these strategies in effect, sponsors can ensure positive trial outcomes and lay the groundwork for a successful future.
Despite the global clinical trial recruitment challenges posed by COVID-19, life sciences organizations have adjusted to virtual engagements and continued to make strides in patient recruitment and satisfaction. As such, adapting to new technologies and changing regulations will be essential to continue on a successful trajectory. Sponsors must keep in mind that traditional clinical trial advertising methods are nearly obsolete and look for more creative strategies to recruit and retain participants. With the right approach, patient recruitment can become a successful and rewarding process.
If you need help with international life sciences recruiting, contact us today.