Guest Post by Dr. Tobias Kruse, Trials24 GmbH, Munich
When you’re planning a clinical trial, patient recruitment is likely one of your top priorities. But today, many sponsors and CROs still rely solely on their sites to deliver patients. This can be a considerable risk for meeting your patient recruitment goals! Today’s clinical trial protocols are getting more complex, the clinical trial landscape is becoming increasingly competitive and patients have other treatment options. This can make it hard for CROs, sites and physicians to know which patients may be eligible for your study and want to participate. The consequence: The feasibility studies are rarely accurate, sites fail to meet their predictions and your recruitment goals are drifting further from reality. Your study is at risk of being delayed. And you wouldn’t be alone: Data shows that patient recruitment is the Achilles heel of clinical trials, with 50-80% of trials being heavily delayed.¹
But what is the alternative? Quite simply, it’s accelerating the patient recruitment process right from the beginning of your study. In this article, I will show you how to support your clinical trial sites with decentralized patient recruitment and ensure your enrolment targets. You will learn:
- why studies stand and fall with patient recruitment,
- what decentralized patient recruitment means and how it can help speed up your enrolment,
- and how specialized patient recruitment service providers can support you in delivering on your enrolment goals.
The Lasagna Law: Why studies stand and fall with patient recruitment
In the 1970s, US physician Louis Lasagna observed the following phenomenon: The number of eligible patients for a clinical trial drops by 90% during recruitment, but returns to normal upon study completion.² This “Lasagna’s Law” is a key issue during trial planning and is one of the main reasons many clinical trial sites underperform during enrolment.
There are various reasons underlying this enrolment issue. One challenge is correctly estimating how many participants you can recruit from your desired patient population. This is especially important for rare disease or cancer trials: Just because there are limited treatment options doesn’t mean everyone affected by the disease will automatically want to enroll in your study. Many patients are reluctant to enter clinical trials for several reasons, e.g.
1) fear of receiving a placebo or sham treatment, or
2) the possible amount and long duration of medical examinations, and
3) too many trips to the clinical trial site.
Another common issue is the study protocol. Are your inclusion and exclusion criteria excessively restricting patient eligibility? Are they absolutely necessary? Just one overspecified inclusion criterium could mean your target patient population goes down by 50% or more.
While it’s difficult to pinpoint the one reason why exactly your patient recruitment is falling behind, the effects of “Lasagna’s Law” can be pretty catastrophic: Most study timelines end up being pushed back by double the time. This is not only frustrating but can also make or break the success of your clinical trial.
So, what can you do to minimize its effects and hit your enrolment goals from the start?
How decentralized patient recruitment can help speed up your recruitment
The solution is actually quite simple: Decentralize your patient recruitment. Sounds fancy, I know! But what does that actually mean? Decentralized patient recruitment means finding patients not registered at your clinical trial site, but who live nearby and bringing them in for screening. Decentralized patient recruitment means not relying solely on the sites as the only source for enrolling patients. Many patients, especially those who are chronically or severely ill, are interested in new treatments and thus open to participating in a clinical trial. They are often organized in networks and groups online, e.g., in Facebook groups or dedicated patient communities. You have cast a wider net for finding eligible patients by directly contacting interested patients and patient organizations.
Traditionally, CROs and clinical trial sites tackle this issue by publishing print advertisements. This includes newspaper ads, public transport systems posters or practice waiting room leaflets. However, the efficiency of print media is declining drastically. One study compared responses to classified ads in local newspapers with the same advertisements online on Craigslist. The authors found the classified ads rate dropped by a whopping 20% of users who found the same ad online.³ Nowadays, most patients use the internet to inform themselves. So, to reach patients directly, you need to find them where their attention is: Online. And by the way, yes, this also counts for older patients, as a Eurostat survey shows:⁴ More than 60% of people aged 65-74 years of age access the internet regularly, with Scandinavian countries leading the charts (here, about 80-90% surf online). The time when older people didn’t know how to use a computer is from a bygone era!
Tip 1: Add decentralized patient recruitment to reach your enrolment goals
Decentralized patient recruitment uses multiple ways to directly find eligible patients not registered at your clinical trial site. This ensures that if one method fails, e.g., your clinical trial sites underperform, the other methods can compensate, and you can keep your study’s timeline. Another advantage is being able to interact with patients directly. Patient centricity is becoming increasingly important.
With highly motivated and well-informed patients as study participants, you increase the chances of both recruiting and retaining them. Patients with a positive experience throughout their clinical trial are also more likely to share the results with peers, increasing the meaningfulness of your research within the patient community.⁵
Naturally, this means you need to plan a decentralized patient recruitment campaign and set aside sufficient resources to raise awareness online about your clinical trial. Such a campaign must find, inform, select, and enable interested patients to participate in your clinical trial. So only raising awareness, e.g., through a newspaper article or a Facebook ad, is not enough. You must also provide further information and a reliable first point of contact for patients with professionals who care and take their issues seriously. Such a patient information service is critical. Because if you only give patients the phone number or email of your sites, even the most well-informed, motivated patient will eventually give up if the site is never available or does not call back. And you might be surprised, but this happens a lot! So make sure to minimize these situations by staying directly in touch with patients through a dedicated patient information service. To connect your awareness campaigns and the patient information service, I recommend you implement a website targeted at patients.
Tip 2: Have a patient-centric website specific to your study
Regardless of whether you are using only printed media, online media, or a healthy mix of both, your study should always have a website for interested patients to learn more about it. Explain what you want to achieve with your clinical trial and who you are looking for in straightforward terms. It is also crucial to be honest and provide readers with information about the chance of receiving a placebo or sham treatment. After all, we must adhere to the ethical guidelines for clinical trial awareness materials, and we cannot “sell” your study to the patients, e.g., by promising new treatments. You need to be careful when using wordings that ethic committees must approve, but are still effective enough to arouse interest in your study.
A website is also the ideal platform to implement a questionnaire to pre-screen and qualify eligible patients. The questionnaire does not have to be overly complex – after all, we’re still at patient level here – so make sure to include the most important inclusion and exclusion criteria of your study. If they pass pre-screening, you can request further information about their medical condition from them or their treating physician. After that you can either verify their eligibility separately or directly forward them to a participating clinical trial site. This way, the clinical trial physicians can quickly discern whether the patient indeed can be included in the study or not. In summary, a website:
- promotes interest in your clinical trial through awareness campaigns and social media sharing,
- is a central platform to inform patients about your clinical trial,
- can be used to pre-screen and qualify eligible patients.
Tip 3: Use specialized service providers to support you in delivering on your enrolment goals
While the tasks seem simple at first glance, they can quickly pile up. For example, recruiting online requires knowledge of Google search volumes and how social media works. Your website content needs to reflect the user’s search behavior, e.g., which keywords are used predominantly for your indication. For example, patients in Germany are googling “Herpes labialis” only 3.600 times per month, but “cold sore” over 27.100 times per month. In other words: If there’s a lay term, patients will always prefer looking up this word instead of the correct medical diagnosis. In the example of Herpes labialis, the difference in patient reach is almost 10-fold! And on top of that, your awareness campaigns and patient materials need to be in line with the ethical and your company’s internal guidelines.
Another challenge is that the pre-screening questionnaire requires staff to take care of the incoming prequalified patients. Such a patient information service evaluates the respondents’ results and reaches out to possibly eligible patients for clarification of the following steps to participate in your clinical trial. Somebody must coordinate contacts between eligible patients and clinical trial sites. If any of these steps are not diligently planned and executed, you may end up failing to reach your goals and wasting resources. But if done right, you will be rewarded with highly motivated patients who will support your clinical trial. Your recruitment is on time, and you will quickly meet your last patient in (LPI) date.
Service providers like us specializing in decentralized patient recruitment can help you manage this daunting task. We can tailor solutions to fit both your study and budget perfectly. Ultimately, by successfully recruiting patients, you can perform your study and get market approval faster. You help bring innovative drugs to patients and help save lives by doing so. And that’s a cause worth fighting for.
¹CSDD Impact Report 2013
²Bogin V. Contemp Clin Trials 2022
³Seamans F et Zhu F. Manage Sci 2014.
⁵Swartz LJ et al. Environ Res 2004.
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