In an article in the New England Journal of Medicine (NEJM), published online on 3 July 2013, Dr Ethan Basch highlights the lack of information on how a drug will make patients feel in the US label of most new cancer drugs. In a therapy area with so many new products in early development, not including patient reported outcome (PRO) measures in pivotal trials for new cancer drugs could turn out to be a missed opportunity!
To be able to promote patient-centred claims in the US, the claims must be included in the label. And to achieve this, the FDA require that PROs are assessed in pivotal trials. Therefore sponsors interested in generating patient-centred claims in their pivotal program need to start planning early, to be sure that any instruments to be used have been validated in earlier phase trials.
In a competitive therapy area where clinical differentiation is likely to be marginal, patient-centred and quality of life (QoL) claims can deliver differentiation and value. And achieving a compelling set of PRO and QoL claims in the label may give a product the edge over others in the same class or therapy area.
Link to the article: Toward Patient-Centered Drug Development in Oncology — NEJM.