Pleasingly, the world is moving on from solely considering the Drs, Scientists, Regulators and Drug Developers’ opinions in considering what a future patient really needs.  The recent ARCS Conference had an outstanding presentation from Ms Gillian Mason, which helped me think more about the needs of the consumer/patient.

Extrapolating from what I heard, we need to carefully consider the prioritisation of undertaking and completing important studies and build the endpoints within them (the researched outcomes) with input from patients.  By this, I mean thinking about what study endpoints reflect patients living improved lives, in particular those with long-term debilitating conditions?  To me this may influence what primary endpoint is chosen vs what a secondary endpoint may be, or what additional secondary endpoints should be there to provide meaningful data and clearly reflect the patient needs and the effect of the therapy to the regulators and payers. I think the desired future of studies for chronic illnesses will be studies including more endpoints that demonstrate patients/consumers continuing and improving their everyday lives, and we as scientists don’t always know what the relative impacts are and what is most important to them. Patient centricity should also mean considering clinical studies being patient friendly and accessible, which minimise patient dropouts from unnecessary and onerous procedures and also have the best chance of being approved by proving the benefit of the therapy beyond doubt to regulators and payers.

With these thoughts in mind, we the scientists need to sit back and see how can we bring the patients/consumers in for their advice in a safe, inclusive and accessible way that minimises the power imbalance and scientific-speak that big corporate and big government engages in and which may by its nature, excludes an individual consumer/patient. We need to hear and incorporate their views as much as possible.

After personally spending 30 years in drug development and sitting on all sides of the fence, I think I speak for everyone in desiring a real patient or consumer advocate as a peer and partner in decision making, for all steps of drug development, including clinical research, regulation, pharmacovigilance and reimbursement. I suggest taking a helicopter view of your job and thinking does it tick all the boxes for a current or future patient, those being boxes which make what you are developing most meaningful for patients?  If not let’s think of a way to get this advice in future, let’s make more linkages with patient groups from an early stage. Their input will only help us do a better job!

Adj. A/Prof Adrian Bootes on behalf of My Medical Department.