Clinical trial patient recruitment is the practice of conducting outreach to patients, evaluating their fit for your trial, and helping them take part if they’re interested. It sounds simple enough, but it has a reputation for taking a long time and slowing down research. However, with the right strategies, patient recruitment doesn’t have to halt your trial’s progress. Below, you’ll find top strategies used by clinical trial patient recruitment companies and sites to connect with interested, engaged patients.
It’s true that research is not happening at the pace that it could — and should. As more and more clinical trials are planned and executed, more and more patients are needed to take part in these trials; 58 million patients to be exact. But just because the trials are there, doesn’t mean the patients are. Eighty percent of clinical trials today are delayed or closed due to difficulty finding patients to take part.
But the fact is that, according to the National Institutes of Health, 85% of patients don’t know that clinical trial participation is an option at the time of their diagnosis. To add insult to injury, a full three-quarters of those patients would be willing to enroll if they were aware of this option.
It’s up to the medical community to educate patients on clinical trials, to help shepherd patients through the process of finding and taking part in a trial.
Clinical trial patient recruitment is an absolutely critical piece to this puzzle. Here, Antidote’s Senior Commercial Manager, Rachel Lind, explains what exactly clinical trial recruitment is all about.
In the past, if a clinical trial needed to find patients to take part, a site might place a classified ad, or purchase a radio spot. These methods are still used, but as technology has evolved, more patient groups have become advocates for research, and more clinical trial patient recruitment agencies have been created, we’ve seen a shift towards more targeted, efficient outreach. To quote Tom Ruane, Global Head of Patient Recruitment at Parexel, “As far as the evolution of patient recruitment, in the early days of digital outreach, we just cut and pasted the inclusion/exclusion criteria. But if you line up all the patients, the vast majority of patients will be disappointed by not making a trial. As an industry, you could say we ran before we could walk. Now, we’re more clever with shortened prescreeners that can help determine eligibility, and more targeted outreach that’s taking patient eligibility and willingness into account.”
So what does modern-day recruitment look like? While many sites still run their own recruitment, these days it is not unusual to hire a recruitment vendor — this is a company like Antidote that has deep experience in finding the right patients for particular trials, and can create a custom plan for your trial. This will include:
Now, we’ll discuss each of these aspects of recruitment in detail.
Even if you decide to work with a clinical trial patient recruitment company, it’s still important to conduct your own research into your trial’s patient population. Here’s how Rachel approaches this task:
Go where patients go: To start, visit websites that patients frequent, such as online support groups, non-profit organizations for their condition, and disease self-management guides. Get an understanding of what it’s like to live with their condition, and how joining a clinical trial might improve their quality of life or care.
Use social media: As you investigate nonprofits and patient organizations associated with your trial’s condition, take a look at their social media presence, too, especially the comments. It’s also helpful to check social media posts for guidance on how patients talk about their condition. When you start to put together outreach materials or review materials that a recruitment company created, it can help to use the same terms and language as patients do. For example, while a doctor may refer to “diabetes mellitus, type 2,” a patient is much more likely to say “type 2 diabetes.”
Think about your visuals: As you conduct your research, think about the imagery in your recruitment ads and materials, as well. If you’re running your own trial enrollment, be sure to include a range of imagery in your advertising for testing purposes to see which connect with your audience the most. Consider trying graphics and icons as well as photography in your advertising. If you’re working with a recruitment agency, ask about the thinking behind their imagery choices and make sure the photos they’ve selected reflect the demographics of your patient population.
Discuss with your recruitment agency: Finding a patient recruitment company that’s worked with your condition area before can give you a head start when it comes to recruitment. In your sales conversations, learn more about their experience in your trial’s therapeutic area and learn what outreach tactics worked best -- and which didn’t. Of course, every trial is different, and depending on your specific trial’s protocol, the same approaches may not work as well even if the condition is the same. The more you understand about your specific condition area, the more you can anticipate recruitment challenges and formulate an effective campaign strategy.
Whether you’re working with a clinical trial patient recruitment company or you’re running enrollment campaigns yourself, there are a few different approaches you can take to finding patients. Many recruitment companies and sponsors use a mix of these approaches to reach patients. Here’s another word from Antidote’s Senior Commercial Manager on the various approaches that are available:
Digital outreach: There are a range of digital tools that can be used for recruitment campaigns, including ad placements on Facebook, Google search results, and banner ads on health-related websites.
Patient database: Some sites and site networks maintain a database of patients that they can tap into for new trials. Clinical trial patient recruitment companies may also use patient databases for campaigns. This can be a highly effective method as patients have already indicated that they’re interested in participating in a clinical trial.
Partnerships: Another way to connect with patients is through partnerships with nonprofits, patient advocates, or community health centers. Depending on your relationship with the organization, they may be interested in promoting your trial through social media or through their email list. Some clinical trial recruitment companies partner with these groups in order to reach patient populations more directly.
Community events: A local health fair, especially one revolving around a particular condition, can be a great way to spread the word about your trial opportunity. If you’re working with a recruitment company that has relationships with local nonprofits or community health organizations, they may work together with another organization to have a presence at a health fair.
Throughout your recruitment campaign, there are several different numbers to keep track of in order to optimize your spending. If you’re working with a recruitment company, discuss how often you would like updates from them on recruitment progress, and what numbers and statistics you’re interested in seeing.
The duration of your campaign, and your arrangement with your recruitment company, help guide how to measure success. If your contract is based on patient randomization, for example, it could be several weeks before the campaign gets a final result that allows you to calculate the true cost per patient acquisition.
In the meantime, you can measure your campaign’s success by metrics that refer to goals from earlier in the funnel. For example, you can track how many eligible patients are filling out your pre-screener to start. Then, calculate how many of those pass a phone or in-person screening.
Your team or recruitment company should be prepared to be flexible, though. Promising numbers in one part of the funnel don’t necessarily translate into success later on. Once you start receiving consents or randomizations from your trial, reevaluate your approach again with this new cost-per-acquisition in mind.
When you’re working with a clinical trial patient recruitment company, you will most likely discuss at which point in the funnel the company will be paid, for example by pre-screener completion, phone validation, on-site validation, consent, or randomization. Companies will charge less for patient leads earlier in the funnel, but you have less of a guarantee that patients will ultimately join your trial.
There are, of course, several barriers to participation that we’d be remiss not to mention. Here’s Rachel again:
Even if patients are aware of trials, the following misconceptions may prove difficult to overcome. Here is some messaging that you as a researcher can use to help clear up these myths:
Myth: Clinical trials are a last resort. While many patients — and even doctors — do not look to trials until all other treatment options have been tried, the truth is that there are clinical trials available for patients at all stages of disease. In fact, many trials are looking for newly diagnosed patients! When a patient is diagnosed, they should speak with their doctor immediately about clinical trials to ensure that all care options are explored.
Myth: Patients need to stop their standard of care treatment to be in a clinical trial. Many clinical trials include standard of care as part of the treatment, and test either additions to standard of care, or standard of care versus a new therapy. In the case of cancer, for example, a patient would never be expected to forgo treatment and be part of a placebo arm — the control arm is often standard of care in this instance.
Myth: Patients in clinical trials are guinea pigs. We prefer to think of them as pioneers. But the truth is that there are phases of clinical trials as the drug gets tested for safety, efficacy, and dosing — by the time a sick patient joins a trial, it is most typically in Phase 3. This means that it has already gone through Phase 1 to test safety and Phase 2 to test efficacy. Patients should be advised to consider what phase trial they’re interested in if being a “guinea pig” is a concern.
Myth: Patients never find out how clinical trials turn out. All trials must submit results to clinicaltrials.gov. But, that can be a tough website for patients to navigate — patients may have more luck simply asking the researchers they are working with when and where the results will be published.
Myth: Patients don’t get to be on a medication once the clinical trial is complete:. In many cases, if a medication is working, a patient is able to stay on the drug after the trial is over. It’s important that that information is communicated as part of the informed consent process — patients should be encouraged to ask this question directly.
Myth: A placebo is administered as one arm of every trial. While it is true that some studies do use placebos, if a patient’s condition is life-threatening or serious, a placebo would never be used. For example, as noted above, cancer patients almost never receive a placebo as part of a clinical trial.
Myth: Patients have to pay to be in a clinical trial. Patients have a better chance of getting paid to be in a trial than having to pay to be in one! In general, insurance will cover standard of care received during a clinical trial, and patients are not charged for access to experimental therapies. Again, this should be spelled out quite clearly in the informed consent.
Myth: It’s very difficult to find a trial that is right for a particular patient. There are many clinical trial matching services (like Antidote Match) available to help patients leverage either technology or patient navigators to find trials that are right for them. And, clinical trial patient recruitment has made great strides in getting the message about certain trials out to the right patients. This is a myth that is simply not true in 2018.
There’s no doubt about it — clinical trial patient recruitment has come a long way since the days of classified ads. So what does the future hold? Our hope is that through technology and with the right partnerships, we can begin to see more patients enrolling, and eventually more drugs coming to market that can improves the lives of patients.
To learn more about how Antidote can help with your clinical trial patient recruitment, leave your contact information on the right-hand side of this page. We’ll be in touch!