Medical research

Are patient partners a necessity in research?

The European Alliance of Associations for Rheumatology has long recognized the pivotal role of patients in the development of recommendations, and the role of patients in research is also evolving. But collaboration with ...

Genetics

Advances in medulloblastoma treatment for children

Though rare, medulloblastoma is the most common cancerous brain tumor in children. These tumors begin in the lower back part of the brain called the cerebellum, which is important for balance, coordination and movement. Medulloblastomas ...

Medications

A simple change to save thousands of patients with sepsis

Changing the way antibiotics are given to adult patients with sepsis will save thousands of lives a year globally, according to research by The University of Queensland and The George Institute for Global Health.

Genetics

Study suggests promising gene therapy for FOXG1 syndrome

A viral gene therapy developed by University at Buffalo researchers has reversed some brain abnormalities in infant mice with FOXG1 syndrome, a significant step toward one day treating children with this severe neurodevelopmental ...

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Clinical trial

In clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be the pharmaceutical or biotechnology company that developed the agent under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization

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