Partnering with patients in the development and lifecycle of medicines – TIRS

Infusion

A wave of new articles on patient-centric drug development flooded the news during the last weeks

It is not a new concept. A task force was started back in 2003 by ISPOR on this topic and several thinkers proposed this vision even before.

One of the more comprehensive article on this topic is the Call for Action written by several experts in the field both in the industry and academia as well as people coming from patient associations, together for the development of a master framework for systematic patient involvement.

Several stakeholders are committed to the success of a specific medicine: researchers, developers, industrials, regulators, insurers, doctors,… but very often they all forget about the main and the most important among them: the patient. He or she is the one taking the drug, benefiting from care or even cure in some cases but also suffering from side effects.

At each stage of development, involving and engaging the patient will bring advantages (pages 8 and 9 of the article gave great figures about them):

– Early research: better prioritization, improved resource allocation, clinical trial protocols reflecting patient needs, superior recruitment rates.

– At launch and beyond: more appropriate benefit-risk assessment, focus on drugs of value to patients, improved treatment adherence.

A part from e-patients blogs, dedicated societies emerge in order to make coordination effort toward common goals like the Society for Participatory Medicine: “Participatory Medicine is a model of cooperative health care that seeks to achieve active involvement by patients, professionals, caregivers, and others across the continuum of care on all issues related to an individual’s health. Participatory medicine is an ethical approach to care that also holds promise to improve outcomes, reduce medical errors, increase patient satisfaction and improve the cost of care.”

In conclusion: “It is essential that all stakeholders participate to drive adoption and implementation of the Framework and to ensure that patients and their needs are Embedded at the heart of medicines development and lifecycle management.”

 

You probably remember the fascinating talk given by e-patient Dave in 2011 during TEDxMaastricht. Dave deBronkart said as an introduction that patients need to be much more involved in order to drive better healthcare as well as superior patient outcomes. The future is now!

 

Additional material

What’s Next for Patient-Focused Drug Development? FDA Announces Final PFDD Meetings, and BIO Recommends Broader Use of the Benefit-Risk Framework – 2015

Partnering with patients in the development and lifecycle of medicine – 2015 – Therapeutic Innovation & Regulatory Science

Integrating the patient perspective in the assessment of benefits and risks of medicines – ISPOR 2014 Workshop

Finding the patient in the drug development process – F. Lewis-Hall (Pfizer) – ISPOR 2013

Toward Patient-Centered Drug Development in Oncology – 2013 – NEJM

 

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