January 27, 2023
Research and drug development for rare diseases are often hampered by the need for large numbers of patients to assess clinical trial outcomes and, in the case of rare neurodegenerative diseases, by slow disease progression. In particular, the “by eye” behavioral assessments currently used to monitor disease progression require long-term observation to detect changes in patient status, may be subject to observer bias, and can lack the precision needed to detect small but clinically relevant alterations in functional capabilities.
Read moreJanuary 12, 2023
One year after it came into force, the new Clinical Trials Regulation (Regulation (EU) No 536/2014) will become mandatory for all initial clinical trial applications from Member States of the European Union (EU) or the European Economic Area (EEA), which includes the 27 Member States of the EU*, as well as Iceland, Norway and Liechtenstein.
*Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, Germany, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
December 13, 2022
November 14, 2022
Diabetes: a major global health issue
Diabetes (Diabetes Mellitus) is a chronic metabolic disease characterized by high levels of glucose in the blood due to deficient production of insulin by the pancreas or ineffective tissue responses to insulin.
It is one of the most rapidly growing global health emergencies, with the latest figures from the International Diabetes Federation (IDF) Atlas indicating that 10.5% of the world’s population (around 537 million people aged 20–79 years) are currently living with diabetes. This number is predicted to rise to 643 million (11.3%) by 2030 and to 783 million (12.2%) by 2045.
Read moreNovember 10, 2022
Decreasing moderate-to-severe pain using an opioid, a fine-tuning process
Morphine sulfate is a well-established first-line opioid used to treat moderate-to-severe pain. In adults and adolescents with cancer pain, the World Health Organization (WHO) recommends reducing pain to a level that allows patients to have an acceptable quality of life.
Read moreOctober 25, 2022
Rosacea: a skin disease of the face that affects the quality of life of patients
Rosacea is a chronic and progressive dermatological disease that manifests as centrofacial erythema and tends to worsen over time. The two most common forms of rosacea (vascular and papulopustular) mainly affect women aged 30 to 50 years. Although it is more easily diagnosed in patients with fair skin, rosacea affects all skin types.
Read moreOctober 18, 2022
Pink October is an annual campaign to raise awareness of breast cancer. Founded in 1985 by the American Cancer Society and Imperial Chemical Industries in the United States, breast cancer awareness month is now a worldwide event.
Read moreOctober 13, 2022
Sight is one of our five senses, and it is hard to imagine what it would be like if we lost our vision. Yet this is what happens to patients with optic neuritis (ON), the most common manifestation of neuromyelitis optica (NMO) and NMO spectrum disorders (NMOSD) in adults, as well as of myelin oligodendrocyte glycoprotein antibody disorders (MOGAD).
Read moreSeptember 28, 2022
September 28 is the “International Day for Universal Access to Information” (IDUAI), an annual event first organized by UNESCO in 2015.
From a medical point of view, the introduction of “lay summaries” has helped to make the key results of clinical trials more understandable for all. In June 2021, the European Commission published Good Lay Summary Practice recommendations to provide guidance to sponsors for the writing of these “plain language summaries“. Indeed, the publication of these summaries is now required according to the new European Directive on clinical trials, European Union Clinical Trials Regulation (EU-CTR) 536/2014, which entered into force on 31 January 2022 and which aims to increase the transparency of clinical trials and ensure better standards for patient safety.
Read moreSeptember 23, 2022
In our news update a few months ago we told you about cystic fibrosis, a rare disease that is one of the areas of expertise of our experienced medical and scientific writing team. In particular, we have already helped our clients with a range of projects on this topic, including:
The “Virades de l’espoir”, walks of hope to help in the fight against cystic fibrosis organized by the association Vaincre la Mucoviscidose in France, provide a timely opportunity to focus on this disease. Similar events take place in many countries around the world, including the Great Strides™ walking challenges organized by the Cystic Fibrosis Trust in the UK and the Cystic Fibrosis Foundation in the US.
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