Overcoming the challenge of clinical trials
Clinical trials and patient access
EB patients willing and able to participate in clinical trials are essential in the process of developing approved treatments, products and diagnostics.
Life with EB is difficult, and planning for clinical trials needs to take this into account. It is important to integrate patients in the planning of clinical trials, and companies planning trials are encouraged to contact patient organisations early in the process to ensure this happens.
Challenges for EB patients taking part in clinical trials
- Competing for ongoing trials
- Exclusion criteria
- Travel & cost
- Additional clinical tests
- Family commitments/bereavement
- Misconception about cell and gene therapies
Recommendations for overcoming some of these challenges:
- Include patients in the clinical trials design from the start
- Carefully consider flexibility of eligibility criteria and ensure it is justified
- Try and open some ‘shared care’ sites such as GP practices or hospitals or meet patients at their home
- Help patients to book travel and hotels where possible and pay upfront from a study account
- Have early, late or weekend appointments available where possible to fit around patients' schedules.
Share knowledge about patients' needs & perspectives
Owing to legislation, EB-ResNet cannot provide companies with direct access to patient registers or contact details of individual patients. However, for companies planning clinical trials, opportunities to participate in trials can be communicated to the patient community via EB-ResNet. EB-ResNet does not provide endorsement of specific treatments, trials or products. Patient recruitment for clinical trials can be facilitated through clinical-network partners. EB-ResNet can help companies understand patient perspectives.
DEBRA International is the umbrella organisation for more than 50 national DEBRA groups. Find out more
EB-CLINET – Clinical Network for Epidermolysis Bullosa is a network of EB centres and experts which aims to improve medical care for people with EB and to accelerate the way to a cure by connecting health care professionals working with EB for the purpose of sharing knowledge and experience. Find out more