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Sjörgen’s syndrome patient recruitment for clinical trials

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patient recruitment

Sjörgen’s syndrome is a rare disorder of the immune system and rheumatic disease that is often accompanied by other immune system disorders, such as rheumatoid arthritis and lupus.

Although some scientists have argued that its not a text book definition of a rare disease meta-reviews of incidence studies show a high variety of prevalence estimates with ranges from 60 to 11 per 100.000 people. This combined with the consistent proven difficulties organizers of Sjögren’s syndrome studies have with enrolling the required number of patients, it makes it one of the most challenging indications to recruit for. At Clariness we have a proven record for Sjörgen’s syndrome patient recruitment

Sjögren’s syndrome

Solving future challenges for clinical trials for Sjörgen’s syndrome

For a long time, Sjögren’s syndrome was considered an orphan disease, because on the one hand the very small patient population and on the other hand there was no therapy that was truly effective. For this reason, numerous largescale randomized clinical trials have been conducted in recent years, but for organizers as well as patient organizations, the results of these large-scale randomized clinical trials have generally been described as “truly disappointing.”  

This year’s meta-reviews of the trial data point out, recent “thorough reflection on the negative data has reinforced the belief that the wide variability in clinical and biological phenotypes of patients with Sjögren’s syndrome makes it very unlikely that a single therapy will result in positive outcomes in all patients.” For this reason, future trials will focus more on various subtypes of a already very small patient population.  

The key takeaway of this for study organizers is that this makes it essential to partner with patient recruitment specialists who have proven experience with Sjörgen syndrome and have a large patient database and pre-screening capabilities to reach out to as many Sjörgen Syndrome Patients as possible and make sure that they match the study requirements.

Sjögren’s syndrome

Sjörgen’s syndrome and minority patient recruitment

n the past years there have been an increasing number of initiatives in both Europe and the United States to boost awareness and thereby participation rates in clinical trials for Rheumatology, including Sjögren’s syndrome.

This was largely a reaction to incidence and prevalence studies showing that incidence and prevalence rates were: 

  • 6 times higher among women than men 
  • Incidence higher among Asian (10.5) and non-Latina White women (6.2) compared with Latina women (3.2) 
  • Incidence was also higher among non-Latina Asian women compared with non-Latina Black women (3.3). 
Clariness is the recruitment solution of the future.
Study Coordinator, Department of Cardiology, Clinic Maria Hilf GmbH
We are very happy with the service and wish the recruitment campaign hadn’t ended so soon.
Study Coordinator, St. Johanes Hospital
We have a very large patient database but it is much easier to use Clariness referrals.
Clinical Study Coordinator, Asklepios MVZ Bayern – Landsberg
Clariness has supported us in patient recruitment in nine studies across six different indications, accelerating recruitment, and increasing screening and randomization numbers. Referrals have been constant and consistent, so we’re excited to see the results of continuing patient recruitment through the ClinLife® Registry.
Principal Investigator, Velocity Berlin
Clariness perform the pre-screening and get lots of information for us, before we contact the patient. It really helps us as we’re a tiny department that does a lot, so anything that helps is appreciated.
Human Research Protection Program Coordinator
It’s a bit like magic – we don’t have to do anything and suddenly, we have a list of interested participants!
Clinical Trials Manager
“I usually never click on ads, but this ad about a clinical trial really appealed to me, so I applied right away. The research center was only 2 km away, so the personal approach was optimal.”

2021 Patient’s Voice participant

How we can help

Our digital targeting techniques

We have four key ways of targeting for COPD patient recruitment.

Demographic

  • Gender (women are 6 more likely to have Sjögren’s syndrome) ethnicity other demographics are used as filters to find patients (and their families and closed ones) most likely to qualify for the study protocol. Based on pre-screener data, this patient profile used in outreach campaigns is constantly updated. This way we are able to target group-specific barriers, from lack of trust in clinical science among minorities, to travel distance and understanding of difficulties in participating and health literacy of elderly patients.

Location

  • We reach Sjögren’s syndrome patients living in areas within a predesignated radius around sites. Depending on the trial protocol, we create a detailed patient profile and matching targeting method.

Interest

  • Patients searching or engaging (e.g., likes, shares, comments, etc.) with Sjögren’s syndrome symptoms (dry mouth) or treatments are shown study advertisements. At Clariness, we apply great importance to the representativeness of our advertising. We include images of people from different backgrounds.

Database

  • We select from over 40+ possible digital channels the most cost-effective option and reach out to our large ClinLife database with a total of 1.3 million users worldwide, based on their location and the trial protocol inclusion and exclusion criteria. As a result from multiple largescale surveys for Sjörgen Syndrome we therefore have a large group of patients in our database.

Some recent successes

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Are you designing a Sjogren’s syndrome clinical trial, or have one underway?

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

 
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