Controlling exposure to often helps patients with asthma, a common condition that is often managed with self-care and inhalers.
While many treatment options can also manage a patient’s symptoms and ameliorate asthma and asthma attacks, ongoing clinical trials seek to improve the safety and efficacy of existing treatments and find new solutions to modify the underlying disease process and improve the asthmatic population’s quality of life.
Christine Tiesler, senior director – inflammation, infectious disease, general medicine, at Covance recently shared her insights on the operational considerations for enrolling and retaining patients for these important studies.
Q: What do you see as some of the challenges in today’s clinical trials studying asthma treatments?
As with any large global study, you need sufficient data for regulatory approval. Asthma, like many other trials, faces increasing competition for patients. Sponsors often need to expand their site list and study a large age range to run their studies, typically working with patients anywhere from four years old to 80.
Q: Given the need for pediatric patients, what should sponsors consider when recruiting for this age group?
When working with pediatric populations, it is important to think from the patient’s point of view. Asthma attacks are naturally very scary and we want to make sure the patients feel comfortable and understand how we are treating their symptoms.
Recruitment involves careful communication to ensure that the child’s caregivers and the child comprehend the procedures. In some countries, sites need to get the signature of both parents on the informed consent form or use age-specific wording for studies with pediatric and/or adolescent subjects.
Q: How are today’s technologies helping ensure compliance during a study?
Compliance is an ongoing challenge in asthma studies, especially for pediatric populations. School life and activities can make it difficult to get to appointments and remain in compliance with the instructions, such as recording symptoms in their electronic reporting documents.
To address this issue, sites can consider using text messaging to ping participants and make participating seem more “cool.” Sites can also provide positive reinforcement for timely and accurate outcomes reporting. In the clinic, we encourage sites to address the burden on families that need to bring a sibling along to an appointment, by providing games or activity books for the waiting room. These small touches can make a difference in patient compliance and retention.
Q: How can you adapt laboratory kits to support patient retention?
We’ve found that younger children often have needle phobia. We can design laboratory kits to use thinner needles, or require less blood sampling and even provide topical anesthetic gel. Even details like the color of the needle can make procedures seem less threatening and help the patients relax. We can also have sites use spirometry devices that are adapted for pediatric populations.
As a result of our experience partnering with sponsors to support their asthma studies, we found that the common phrase “one size doesn’t fit all” is important to accommodate a wide range of asthma patients for these ongoing studies in both adult and pediatric populations.