Traditionally children and young people have been excluded from participating in clinical trials or have not had the opportunity to be involved in the design of clinical studies. However, this doesn’t mean that involving paediatric patients is not feasible and involving patients does have important benefits. It’s time to shift from a drug-centric approach towards a more patient-centric approach where patients have the right to be involved, along with the required means, methods and resources.
c4c offers opportunities for involving children, young people and parents in the drug development process, from the early stages, when it’s essential to know the specific unmet medical needs that a paediatric condition entails, to the dissemination of the clinical trial results.
The c4c patient involvement model is based on key principles:
- The design of better trials for children and young people means a future healthy society. It is a responsibility of researchers to design treatments considering the best quality of life opportunities for patients.
- Children and young people have the right to express their views and to be involved in decisions regarding their health. We need to provide the right means and activities to ensure these rights and to facilitate an active role of patients in research.
- Patient involvement in research is carried out “with” or “by” patients, not “about” or “for“ them. As soon as we can involve patients and their parents, we can ensure that their needs and preferences are included in the clinical trial design phase.
- Involve paediatric patients requires expertise, planning and assessment. c4c offers the expertise of well-known experts in the field to facilitate the involvement of children and young people considering their needs and providing the friendly methods of participation in advisory activities.
- An international approach for the involvement of minors and parents is essential when we involve them in clinical research. Paediatric clinical trials are performed in more than one country and under the umbrella of c4c it is an essential part of c4c to involve Patients from different countries within the Network. Diversity is an important element to be considered when involving patients in clinical trial design.
- The c4c team, who are working in patients involvement activities, invite you to share your interest in paediatric clinical trials. If you are a young adult patient, a carer or involved in a patient organization, submit your contact details and your expression of interest to our patient expert data base.
- In the case that any patient involvement opportunities arise in your specific condition, we will contact you. Prior to your participation, we will provide the information about the activity (goal, time to commit, etc.) and we will equip you with all the knowledge that will be required to facilitate your participation in the c4c patients’ involvement activities.
c4c have a library of resources which are aimed at anyone with an interest in patient and public involvement in paediatric clinical trials and can be viewed here: https://conect4children.org/educational-resources-library/