Patient recruitment has often focused on traditional media methods like TV, newspaper, and radio, which often lead to a low recruitment conversion rate. Digital patient recruitment can target specific communities that are both more likely to be interested in and eligible to participate in the clinical trial which, in turn, can save money and keep the clinical trial on schedule.
What is patient recruitment?
Patient recruitment is the process of identifying, screening, and enlisting eligible patients that are willing to participate in a clinical trial.
There are different methods of patient recruitment. Traditional advertising media channels include TV, radio, or brochures. However, the use of these methods often results in a majority of interested patients being ineligible to participate due to specific exclusion criteria. Investigators can use existing patient databases to identify possible candidates but only patients who are searching for clinical trials would be registered in these. That leaves a large untapped market. Patients can also be recruited directly by their physician or an advocacy group. This recruitment method generally has a higher conversion rate: the number of potential participants informed about the trial vs. number of patients finally recruited to participate. Patients are more likely to be persuaded by a personal connection than a mass marketing advertisement. Both the physician and advocacy group earn the patient’s trust and act as a liaison informing them of the benefits of the trial and calming any hesitations. Digital marketing is also becoming more prevalent. This includes advertising online using keyword targeting. 1 in 3 adults have researched online for medical information. Specific ads are pushed to people who use particular keywords when discussing their conditions on social media or while searching for treatments using search engines. Digital tools can help target wider audiences who already are engaged and interested in a particular illness. These methods typically offer more of a return on investment of advertising funds.
Challenges of patient recruitment
Bringing new treatments to market as quickly as possible is the goal of every clinical trial team. Patient recruitment is a critical part of the trial schedule and budget. If a trial has trouble with patient recruitment, it can extend the length of the trial timeline and incur additional costs. Also, if the trial fails to get enough participants, and the pre-established sample size is not achieved, it could cause the sponsor to abandon the results. Ultimately, efficient patient recruitment can reduce costs and can ensure the trial completion.
One of the main challenges to patient recruitment is that the number of available patients who meet the trial inclusion criteria is often fewer than expected. Since conversion rates are usually low, around 10%, the size of the initial patient pool will affect the total number of participants. The next challenge is identifying and targeting the groups that meet eligibility requirements. Most people are not familiar with what a clinical trial is or how to participate in one. Therefore, in addition to the challenge of finding eligible patients, it is necessary to also educate and convince them to participate. Finally, patient retention is another challenge to completing clinical trials. Patients volunteer to participate in clinical trials and can choose at any time to quit. Prolonged interest in the trial is a vital characteristic that one should look for during the recruitment phase.
How to conduct proper patient recruitment
After the proper approvals have been processed for the trial, and the research team assembled, then it is time to start patient recruitment.
- The first step to patient recruitment is to select the eligibility requirements for participation and to establish a target audience. Once an ‘ideal’ candidate has been identified, research into that persona type will help the recruiter understand how best to market to them. This research should include:
–motivation to participate: What will it take to convince the patient to volunteer their time and energy to participate? Are they motivated by money? In the search for a cure? Will the trial help their condition? What is the value proposition you are offering the candidate? Clearly articulate the relevance of the study and emphasize the possible benefits in your marketing materials.
–condition area: What condition do they have? The type of condition may affect a patient’s willingness to participate in trials. According to a study, patients with chronic conditions are less likely to participate in trials for new drugs because it can take a long time to find the correct treatment for these conditions. You should tailor the outreach approaches to match the type of condition.
–best marketing media: What marketing channel will they most interact with? What age is the ideal candidate for your study? What media type do they want to interact with? Does this person want a brochure, video, blog, pdf to download? The marketing strategy you develop should match these aspects of your candidate.
- Create a simple process for participation. The intake paperwork should be user-friendly, easy to understand, and accessible. Electronic enrollment is one way to simplify this process and gain more interaction with possible participants. Digital tools include online screening questionnaires, scheduling services, and trial information materials. It should be easy for a participant to contact someone involved in the trial and ask questions; this can also be done online.
- Next, set goals, milestones, and track the conversion rate– how many people see and interact with your marketing vs how many enroll. This will help determine the number of people that need to see your ad before you get enough for your trial- help determine the type of advertising. You may do this through a pilot study and/or through analysis of past trial recruitment statistics.
Once you have one persona for each of your ideal candidates, then you may choose to run a pilot study. A pilot study is a scaled down version of the clinical trial requiring fewer participants which tests the trial’s feasibility. If the pilot study fails to recruit enough patients, then it is likely the trial will also fail, and resources would be wasted. The pilot study will also help the researchers identify potential barriers to patient recruitment. Adjustments to the recruitment strategy can be implemented to avoid the same pitfalls during the patient recruitment. This may include changing screening criteria, adding more test sites, or modifying the marketing mix.
If you choose not to do a pilot study, you may analyze data from your past enrollment performance to help you determine a feasible enrollment estimate. This will allow you to adequately manage the finances and staff resources of the study. Pay attention to the number of patients recruited, how long it took to get the first enrollment, and what percentage of the enrollment goal was achieved. Use this past data to identify what form of marketing worked best for the audience.
- Create a marketing strategy. Identify the marketing mix for your message (place-where will you advertise, product-how will you position your trial, price-what is it that you will give the volunteers, promotion– how will you tell your audience about the trial, process-what is the process to be involved, people-who is involved to get your trial participants). Make sure the information is clearly written and easy to understand, pay attention to not use complex medical jargon. Patients need to feel comfortable with the trial and understand the process. The marketing elements should have a clear call to action. Offering them a roadmap of what is expected of them and how the results will be used.
- Start recruiting and stay organized. Execute your carefully planned recruitment. Track all your results and capture, in detail, the contact information from interested patients, even those that may not be eligible because perhaps they will be interested in a future study. Remember to ensure patient privacy and that your data collection/retention is following all privacy laws.
Tailor communication strategy. Communication is key to building trust, establishing expectations, explaining processes, and keeping the patients informed. The communication plan starts the first interaction the patient has with the trial. The marketing materials should anticipate and answer the patients’ questions. Do the images and terminology reflect the target population? Take into consideration cultural and language differences of your participants. This will make them feel more at ease and comfortable with the process of the trial.
Follow up with patients. Incorporate digital elements like text messages, automated emails or personalized scheduling reminders. These tools can be used to remind patients to take the next steps. Is there constant contact with the trial participant to keep them involved in the trial? Incorporate a range of outreach methods to reach patients and provide them with the necessary information and useful content to keep their interest.
Answer every question the patient has regarding the trial. Keep the physician or advocacy group involved and address any doubts, concerns and to convey the benefits of the study. Use social media platforms to keep connected with the audience and inform them of the results via mixed media like infographics and video.
Show appreciation for the trial participants. Many are receiving financial compensation but that is not always enough to get a participant to “buy into” the study and continue to give their time. How can this trial benefit them- does it help give them a better understanding of their condition? The trial will also move research forward and can help other patients like them in the future.
Keep it interesting. Recruitment and retention are largely affected by the enthusiasm of the lead investigator. If they are showing interest and providing proper follow up because they believe in the success of the study, the participants will too.
Include digital tools. Online aspects are used for patient recruitment, retention, and for the trial itself. Digital patient recruitment can target more precisely a larger audience. Follow up messages via email, social media, or text messages are a great way to encourage patients to take the next step and keep them interested. Tracking enrollment numbers and keeping an updated database can help keep investigators organized. The clinical trial itself can be performed ‘decentralized,’ where the patients are all virtual. Digital clinical trials can widen the eligibility pool. If the trial is available remotely, then there are more people that can participate as location is no longer a limitation. In-person aspects of the trial should be coordinated in conjunction with local health sites. Direct-to-patient lab services are also available and can be explored when necessary.
Recruiting enough patients that qualify for clinical trials is always a challenge. Traditional marketing methods often fail to recruit enough trial participants. Now, with the use of digital tools, it is possible to more efficiently and cost effectively target patients willing and able to participate in trials. EvidentIQ offers a suite of applications within a single integrated cloud platform for clinical data management, clinical operations, and patient centricity. These digital tools not only help for recruitment but also with patient tracking, communication, retention, and can provide statistics for when planning your next clinical trial.
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