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The growing insistence on making healthcare more patient-centered - Europe is currently awash with declarations of intent along those lines - is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating.
The growing insistence on making healthcare more patient-centered - Europe is currently awash with declarations of intent along those lines - is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating. After all, there is little logic in putting the patient at the center if the patient has no idea what to do once he or she is there. The world of clinical evaluation is among the most committed to such an approach, for a raft of reasons ranging from efficacy to ethics.
In late October, the European Medicines Agency (EMA) recommended granting a marketing authorization under exceptional circumstances for a treatment for erythropoietic protoporphyria-in a procedure that, for the first time ever, involved patients directly in the assessment of benefits and risks of a medicine. The EMA’s scientific committee made its recommendation after hearing from patients treated with the product on a compassionate-use basis, who reported improvements to their quality of life.
This is just one manifestation of a trend that is being driven both by new technologies - permitting more individualized treatment - and by the increasing challenges that many trial sponsors encounter in recruitment of subjects. At the same time, patients and patient groups are also taking a more assertive stance in some therapy areas - inspired by the successes of the AIDS/HIV campaigners of earlier decades-and demanding access to innovations such as the new generation of hepatitis C treatments.
But closer or wider or deeper or more constructive involvement of patients-in clinical trials or in other areas of medicines development and delivery-depends itself on how far patient engagement and alertness and goodwill (and a lot of other group characteristics) are developed across the broad patient or citizen population.
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