Controlling exposure often helps patients with asthma, a common condition that is often managed with self-care and inhalers.
While many treatment options can 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, are general medicine, at Covance recently shared her insights on the operational considerations for enrolling and retaining patients in 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 in order to run their studies, typically working with patients anywhere from four to 80 years old.
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, so 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 aspects of clinical trial compliance, such as appointment attendance and symptom tracking, more difficult for pediatric populations.
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 siblings 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, require less blood sampling or even provide topical anesthetic gel. Even details like the color of the needle can make procedures seem less threatening and help the patients relax. Sites can also use spirometry devices that are specially adapted for pediatric populations.
As a result of our experience partnering with sponsors to support their asthma studies, we found that one size doesn’t fit all is important to accommodating a wide range of asthma patients for ongoing studies in both adult and pediatric populations.