Migraine patient recruitment for clinical trials

Need help accelerating your study?

Migraine patient recruitment for clinical trials

Need help accelerating your study?

We leverage an in-depth understanding of local patient populations to drive patient recruitment campaigns for global migraine clinical trials

Migraine is a common condition that causes a variety of symptoms but generally is characterized by periods of pulsing headaches. About 39 million of people in the US, 41 million in Europe and almost 1 billion worldwide are affected by the condition, that is sometimes also simply referred to more broadly as headache disorders.

An ongoing challenge in migraine research is that participation in clinical trials is hindered by migraine patients not searching help because of stigma and lack of awareness as they see the disease as just a “headache”, as the US Migraine Foundation states in a recent report. As a result, some 75% of all patients remaining undiagnosed according to recent estimates published in Neurology, traditional recruitment methods or basic digital recruitment are insufficient.

Having performed migraine patient recruitment for 10+ international trials, from Phase I to IV (including both adult and adolescent patients), we know how to reach and enroll migraine patients of various backgrounds.

Understanding and recruiting migraine patients of various backgrounds

Clinical trials for migraine usually focus on one of two types of the condition: migraine with aura and migraine without aura, with the latter referring to headache that are happen alongside or are preceded by sensory disturbances. Yet, there are many types of migraine and more so, recent reports estimate that a large part of the global migraine patient population remains undiagnosed.

This means it is on the one hand crucial that study organizers match their study protocol with the potential study population in proximity to planned sites. On the other hand, it requires outreach methods that reach patients who fulfil the study requirements but, for various reasons from stigma to lack of awareness, do not look for alternative treatment options through for example doctor offices.

At Clariness, we leverage our thorough understanding of the local patient populations in our patient-centric digital patient recruitment campaigns for migraine. We conduct our own surveys, but have also supported the largest ever survey of 21,000 migraine patients in Germany to determine migraine patients’ needs and willingness to participate. In combination with data-driven evaluations, we can accelerate the recruitment of your migraine studies.

Smiling physician sitting in front of a laptop

Migraine patient surveys: understanding the local study populations

Any successful patient recruitment campaigns depends on a understanding of the to be recruited patient population. How do they feel about current treatment options, how aware are they about their condition, what are their perceived benefits and challenges that influences their willingness to participate?

This understanding is essential for selecting the most effective recruitment channels and which types of advertising work best for specific digital patient communities.

There are a number of ways that sponsors can improve their understanding of migraine patient populations for their planned clinical trial. At Clariness, we regularly conduct patient interviews, stay up to date with academic research on migraine patients and with our Patient Centric ClinLife portal support sponsors who want to conduct patient surveys for migraine.

We for example supported the largest migraine survey to date in Germany, which results in early 2022 were published in Nature and were summarized in our whitepaper “Patient understanding and recruitment for Migraine Trials”.

Addressing patient diversity in migraine trials

Historically, minority and marginalized populations are underrepresented in clinical trials – despite evidence that these populations may be at increased risk of certain health conditions. While it is generally known that migraine is more common in women (up to three times more common), recent studies show that this indication may occur with different frequency in different ethnic groups. For example, the prevalence is significantly higher in Caucasians (20.4%) than in Africans (16.2%) or Asians (9.2%), while a similar pattern is observed in men (8.6%, 7.2% and 4.2%).

As our Migraine whitepaper highlights, recent surveys show how Migraine patients with Turkish-background in Germany “do not seek medical care because of lack of awareness”. More so, younger migraine patients have generally less awareness of the their condition, let alone of treatment options or the importance of clinical research.

A commonly cited challenge for migraine clinical trials is a unbalanced gender enrolment clinical trials. Despite that migraine is at least three times as common in women as it is in men, the International Headache Society Clinical Trials have highlighted that in clinical trials there are often fewer male participants then is required. This can be linked to recruitment practices relying on referrals from doctor offices where women have a higher consultation rate for migraine than men.

As we argued in our academic whitepaper “Achieving Diversity in Clinical Trials”, digital patient recruitment offers a fast and efficient way to broaden the geographic scope to target eligible Migraine patients. Our 10+ years of experience recruiting for Migraine studies allows us to select outreach tactics that make for a representative and diverse study population.

Patient viewing smartphone screen

Leveraging Decentralized and Hybrid Clinical Trials for migraine

Embracing new decentralized clinical trial (DCT) solutions can help your migraine clinical trial stay on track and reduce patient drop-out. The clear and often mentioned advantage of decentralized or hybrid trials is that it reduces the number of visits to the study center, thereby making participation more feasible for people in remote areas or who are busy with work.

Another advantage of digital technology in migraine clinical trials is that the information is immediately accessible to site staff. This is particularly important for migraine studies, which often focus on quality of life data collected from patients, for example through electronic headache diaries.

We can help you adopt new approaches and transform your trial by navigating regulatory changes, creating study materials for patients and caregivers to better understand new technologies, and providing intensified support to sites to reduce site burden. Our experience with hybrid and DCTs can be applied directly to your study.

Our digital targeting techniques

We have four ways of targeting patients and caregivers when performing migraine patient recruitment or migraine patient surveys, and continuously review performance to optimize engagement and trial registrations.

Location and capacity targeting

Migraine patients living within a predesignated radius around active sites are targeted with a variety of advertisements in the local language and based on the local patient profile, that are activated and deactivated based on site referral volume.

Interest-based targeting

Patients searching or engaging (e.g., likes, shares, comments, etc.) with migraine related content are shown ads and directed towards explanatory landing pages. The focus of ads and landing pages is to explain the condition, raise awareness about the condition and research and reducing stigma. This way even the 75% of undiagnosed migraine patients can be recruited into trials.

Demographic targeting and pre-screener

Gender, age, and other demographics indicators are used as filters to target patients that likely fit the study criteria. An patient-centric pre-screener can furthermore help patients find out of they qualify for the study, for example by the number of migraine days in one month.

Behavioral targeting

We continuously analyse the behavior of those who did qualify and register, and those who didn’t. This allows us to target patients with similar behaviors to boost conversions and improve ROI. This data-driven pre-screener successfully filters and only refers patients who are likely to be randomized, reducing site workload and patient frustration and disappointment.

Are you designing a migraine clinical trial, or have one underway?

We can help you find the right patients, at the right time. To find out more about our migraine patient recruitment, contact us.