The clinical trial process can be challenging, especially in the design phase. Research suggests that engaging with participants at an early stage can improve the reliability of the trials and have a direct impact on cost.
A recent survey revealed that 97 per cent of patients feel participants should play an integral part in the development process. A further study showed that logistics, including location, timing and transportation, was the number one consideration when it came to deciding whether to participate in a clinical trial.
Making the trial patient-friendly is important, which is why it is vital to listen to participants and address any concerns they have, removing barriers that could prevent them from taking part. Depending upon when changes have been implemented, patient input can have a significant impact on initial trial design. Enrolment and retention levels may be improved and costly mistakes avoided depending upon when any changes are implemented.
Clinical trials are a vital aspect of developing new treatments. Patients need to be introduced to the design process as early as possible during adaptive phase 1 clinical studies (http://www.richmondpharmacology.com/adaptive-phase-i-studies.php). This is crucial not only in terms of saving money, but also in gathering useful insights into participants.
Patient involvement might include:
Co-creation Workshops – Bringing together important stakeholders, such as clinical coordinators, development staff, investigators and patients, to pool together ideas, discuss issues, identify potential problems and map out patient and site experience. This is also the ideal time to help patients gain a greater depth of understanding about the the trial, its purpose, aims, objectives and the requirements of them as participants.
Study Team Patient Advisor – Study teams should include a patient advisor. This is someone who has had previous personal clinical trial experience and is knowledgeable about their illness and treatments. This enables the patient representative to not only participate in reviews of protocol, but also provides a more personal perspective from the patients’ point of view throughout the whole process.
Patient Councils – This is a group of trained caregivers and patients who can be consulted on key topics via face-to-face meetings, written feedback or telephone/video conferencing. It is important to ensure these carefully selected individuals are trained so they have a full understanding of the complexities involved in clinical development, further validating their feedback.