Recruiting patients to enroll in clinical trials requires a methodical approach. Whether it be a new drug, therapy or device entering the market, the pharma companies launching these treatments have to effectively recruit the right patients. (Clinical trials are essentially research studies conducted to collect the necessary data that quantifies the safety and efficacy of a proposed treatment.)
Research shows that as much as 86% of clinical trials do not reach patient recruitment deadlines. This can lead to increased costs, drained resources and inefficient use of resources, unmet needs of stakeholders, and unmet drug launch deadlines.
Meeting patient recruitment deadlines is difficult for a number of reasons. Pharma companies must be able to reach prospective patients to educate them about the clinical trial and encourage them to participate. To become eligible for the clinical trial recruitment process, prospective patients have to meet specific eligibility criteria, including a number of inclusion criteria and exclusion criteria.
Any initiative that involves multiple stakeholders (HCPs, sponsors, and clinical research teams) can be challenging. Pharma companies must meet the needs of each stakeholder without sacrificing anyone’s needs. Deadlines are tight during clinical trial recruitment, and individual goals need to be met throughout the timeline to stay on track for a drug or treatment launch.
Communications must be streamlined, effective and personalized for individual target audiences. Pharma companies also need to ensure physician awareness of the available clinical trials and ensure that eligibility criteria are practical.
For pharma companies to maximize patient enrollment, they require an expert recruitment strategy that educates key stakeholders through effective digital and traditional marketing.
Evolving Nature of Clinical Trials
Over the years, methods for engaging and educating patients about clinical trials have transformed.
The devices and platforms patients use to research available clinical trials have ultimately shifted from traditional to digital. Previously, information about clinical trials was often spread through direct mail and through patients’ appointments with their healthcare providers. Face-to-face, traditional methods of patient recruitment have been supplemented and many have been replaced with digital media methods, such as e-mail marketing and search engine marketing.
With the rise of digital marketing and increased access to clinical trial availability, patients are also now more involved in the recruitment process than ever before. Recruitment efforts have taken a patient-centric focus to align with recent changes in patient engagement. Instead of seeking information face-to-face from their healthcare providers, friends or family members, patients are informing themselves through the internet. Patients are searching for up-and-coming treatments or therapies, and sharing experiences with their peers on various websites and social media platforms.
Pharma advertising agencies and marketers have shifted their approach to accommodate this change in behavior—which means taking to the internet to reach eligible patients where they’re present.
Constructing an Effective Clinical Trial Recruitment Process
To increase recruitment rates, pharma companies must know where to reach eligible patients and how to reach eligible patients. Once potential patients are identified, they must undergo a pre-screening process to confirm that they meet the inclusion criteria and exclusion criteria. Patients then need to be connected with a clinical research site and supported through a strategic follow-up process that promotes appointment scheduling while the patient, or lead, is still “warm”.
1. Identify patient population media habits.
First of all, who is the patient population for the clinical study? In this phase, market research is performed to understand the specific media consumption behaviors of the patient population. What channels are they currently using? What platforms are they using to search information or connect with other patients in their community?
Identifying the patient population is critical for choosing the appropriate channels to market clinical trial recruitment needs, as well as tailoring the message and personalizing it to resonate with the intended audience. What pieces of information are most important to that specific patient population?
Because many patients are still learning about clinical trial patient recruitments through their healthcare providers, it’s beneficial to identify the HCPs currently diagnosing and treating the condition of the clinical trial. What type of HCPs are involved with the condition—physicians, nurses, behavioral therapists? This can help you spread information about recruitment needs and provide valuable insight into the media behaviors of other patients in the community.
Where are these patients searching for information—social media, online advocacy groups, support groups, print materials? Develop a marketing strategy to advertise on these frequented channels. Market research will tell you whether paid advertising, search engine advertising, or traditional print advertising is best suited for your audience.
2. Develop a pre-screening and screening strategy.
Once the potential participants have been identified and reached, trial sponsors and recruitment leaders need an effective strategy to screen these patients.
What eligibility criteria need to be assessed to ensure patients are qualified for the clinical trial? Which qualities or features must they have (inclusion criteria) and which qualities or features must they not have (exclusion criteria) to be eligible for the clinical trial? Patients are often pre-screened by research organizations, over the phone or through the internet, before the face-to-face screening process. There are call centers and research sites dedicated to this step of the process.
If patients meet the necessary criteria during the pre-screening process, they’ll move forward to an in-person screening process. The screening process often includes a physical exam and a review of the study participants’ medical history. Mental health assessments and lab testing are also common during the screening process.
3. Connect patients to their study sites.
Pharma companies must aid the process of eligible patients reaching their study locations to ensure successful recruitment. This process should be as simple and user friendly as possible, to avoid eligible patients dropping out of the process before reaching the research location.
To streamline the process and encourage a seamless transition from screening to site selection, companies need to develop a system to be expeditious in connecting patients to their sites. One common technique used in this stage is called a “warm transfer.” At the end of the screening process, when a patient is still on the phone with the call center representatives or trial sponsors, they may three-way call the research site to connect the patient with the research team.
Call center operators and trial sponsors should also be prepared to share information about the soonest available appointments for patients to attend. To successfully recruit patients, the research team must do everything they can to facilitate the appointment scheduling process and support patients from the pre-screening stage up until they attend the site appointment.
Any helpful materials that include information about the appointment (listing the date, time, and location of the research site) should be given to the study participants too.
4. Follow-up with patients and monitor the turn out.
The time between patient referral to patient enrollment is precious. Sponsors and research teams need to minimize this time in order to maximize the number of patients successfully recruited. Monitoring patients throughout the recruitment process and offering the support and information they need is essential to retaining as many patients as possible.
The follow-up process is often done through an online portal or software that enables the sponsors and research team to monitor participants as they progress through the clinical trial. These specialized systems can also show data on the number of patients successfully recruited per research site. Data from these systems can drive insights into whether the inclusion and exclusion criteria are practical, and which specific locations are in need of more participants.
Part of the follow-up process is providing continued support for patients, whenever necessary. This includes after-hours support, support with appointment rescheduling, as well as streamlining resources and information to ensure a seamless process.
On average, clinical trial patient recruitment rates are considerably low. Once eligible patients are identified, the pressure is on to retain these patients and ensure that they meet all milestones throughout the clinical trial process.
Call center operators must be easily accessible to patients throughout the process. They should be available to answer questions, provide information, reschedule appointments and follow-up with patients every step of the way.
How Good Apple Can Help
Securing study participants and retaining them from patient referral to appointment follow-up is a challenging undertaking that requires a strategic approach.
Overcoming the common challenges of clinical trial recruitment (meeting strict recruitment timelines, meeting the needs of key stakeholders, reaching prospective clients where they’re receptive, ensuring physicians are aware of available clinical trials, and streamlining communications between HCPs, trial sponsors and patients) requires expert solutions. We have fine-tuned our approach from years of experience enhancing patient retention in clinical trials through comprehensive, custom marketing strategies that work to mitigate the common challenges of the patient recruitment process.
