Patients today aren’t just taking part in clinical trials – they are playing an increasing role in the design and development of clinical trials.
This is an important step forward in the clinical trial process. Patient input helps companies better understand the perspective of those living with the disease being studied which can ultimately help refine study designs and operational approaches. In turn, this boosts recruitment and drives more clinically relevant outcomes.
All stakeholders including patients, health care professionals, biopharma companies, regulators, payers, and even politicians, accept that more patient involvement in drug development is needed, although a widely accepted standard for what constitutes patient centricity is yet to be established.
Putting patients at the centre of clinical trials has the potential to make the development process more effective, which makes ‘patient centricity’ attractive. However it also requires a paradigm shift which makes it challenging. Changing the role of the patient from ‘subject’ to ‘participant’ needs an altered culture, mind-set and framework.
The core goals of patient centricity in drug development should include:
- meaningful inclusion of patients, in particular for trial protocol design
- linking needs of patients with goals of clinical trials
- considering patients’ experience of their disease throughout the program
- taking patient priorities such as convenience, pain, expense and benefit into account
- measuring what matters to the patient
- giving patients appropriate, timely and user-friendly information
- using technology to include patients more
- including voice and values of patients
Although ‘patient centricity’ has not been formally defined, it is clear that a patient centred clinical trials here to stay. All stakeholders involved in clinical trials need to embrace patient centricity if the aim is truly to optimise the chances of successful clinical trial outcomes. Without patients and their willingness to be involved, there cannot be clinical trials.
Call our Clinical Development team on +61 3 9251 0777 to discuss how we can provide you with vital clinical trial design support and any other support you need to make your clinical program a success.
This article was written by Ric DeGaris from our Clinical Development team.