Introduction Patients were asked by GlaxoSmithKline staff members to review a draft plain language summary from a completed Phase III study. The patients provided valuable feedback about the wording,...
Introduction Novo-Nordisk, a pharmaceutical company, does user research with patients to enhance understanding of patients and to develop products that meet users’ needs. Where in the process? – Phase...
Introduction A collaboration of Genzyme, International Pompe Association (IPA); UK, Dutch, and US Pompe patient organisations, Erasmus Medical Center and Duke University to establish appropriate measures to ensure the...
Transcription I am a Victoria Fonsou, from Greece. I am a breast cancer patient and also a caregiver of my father, who has just been diagnosed with colon...
Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatments participants have received during a clinical trial.
In the current Clinical Trials Directive, the definition of conditions for inclusion of vulnerable populations is limited to clinical trials with minors and incapacitated adults who are not able...
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
Digital health technologies (DHT) can be deployed over a broad range of use in healthcare. This entails different approaches in their regulation and the assessment of their benefits, risks,...
Compensation in clinical trials is not always a standard but may be offered to participants according to different models and in line with the respective legislation and regulations.
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