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Czech clinical trials lead with 40% increase in cancer drug studies – Euractiv

In Czechia, new data shows over 16,000 patients have been included in the research efforts for new drugs and vaccines, with clinical trials most frequently focusing on oncology and immunology.

According to the European Medicines Agency (EMA), around 2,800 clinical trials are authorised annually in the EU. Approximately 60% of these trials are sponsored by the pharmaceutical industry, with the remaining 40% conducted by non-commercial sponsors, mainly academic institutions.

This extensive and expensive process, often spanning 10-15 years, involves multiple phases of development.

The EY analysis commissioned by the Association of Innovative Pharmaceutical Industry (AIFP) provided an overview of the Czech research environment for innovative pharmaceutical companies in 2023.

During this period, 481 clinical trials of new drugs were ongoing, with 107 studies initiated that year alone.

Compared to 2021, this marks a 21% increase in the number of studies, particularly in oncology, which saw a 40% rise. There were also increases in cardiovascular and respiratory disease research, although the number of projects in rheumatology gradually decreased.

“Research into new medicines is helping to push the boundaries of medical knowledge about many diseases and their causes, contributing to improved care, patients are getting access to potentially effective treatments much earlier, and professionals are actively educating themselves and contributing to the development of scientific information,” explained David Kolář, executive director of the AIFP, during the presentation of the new analysis.

“The health budget also benefits. In 2023 alone, it saved more than CZK 1.5 billion (€60 billion) in the costs of treating patients, which are covered by the sponsor of the research project, in most cases the pharmaceutical company,” he added.

Fewer volunteers in studies

In total, 16,140 patients voluntarily participated in these research projects in 2023, a decrease of 10,000 compared to 2015. The most significant declines were seen in immunology, neurology, rheumatology, and psychiatry. Conversely, the number of patients involved in cancer, respiratory, and cardiovascular disease research increased.

“The overall reduction in patient numbers is linked to a shift in research designs, moving away from large studies with many patients towards projects focusing on rare diseases and personalised treatment,” Kolář noted.

“The decision to participate in a clinical trial must be truly the patient’s own. We, as doctors, offer the study when we believe it’s suitable for the patient. However, we must clearly explain what participation entails, the associated risks, and the potential benefits without promising a favourable outcome,” said Jan Vydra, head of the clinical department at the Czech Institute of Haematology and Blood Transfusion.

Last year, 2,322 research teams were involved in the development of new drugs, a 23% increase compared to 2021. The largest growth occurred in cardiology and oncology.

“We engage in pharmaceutical company projects and also develop our own treatment methods, such as immunotherapy, where we aim to produce genetically modified white blood cells for treatment,” said Vydra, representing the largest haematology centre in Czechia.

According to Beata Čečetková of TWMA Clinical Research, an independent research organisation based in Prague, Czechia, has a well-functioning pre-clinical phase, which is often in the hands of academics and independent research institutions.

However, the following two phases, when drugs are tested on a smaller number of people – mainly to determine their safety and efficacy – are less represented in the Czech Republic.

Still, the third phase of research in the Czech Republic is the dominant phase.

“This critical phase tests new treatments on a large number of patients to verify their effectiveness and safety before approval and market release. It provides key information to determine whether the new treatment is suitable for broader use,” explained Čečetková.

“In this phase, we already know the correct dosage, preliminary side effects, and basic efficacy. Phase three aims to confirm good efficacy and ensure no rare side effects occur,” Vydra confirmed.

Clinical research moves eastward

Despite these advancements, the clinical trial landscape in Czechia faces challenges. The process is fragmented, with each healthcare facility having different rules and significant administrative burdens, causing delays in study commencement.

“If the Czech Republic wants to remain on the clinical trial map, systematic support for the research environment is essential. Strengthening clinical trial departments and reducing administrative burdens through digitalisation are critical steps,” Kolář emphasised.

The analysis presented by Czech AIFP also pointed out that this year, the total number of clinical trials in Europe reached 140,300, which is a 20% increase compared to 2022. Some countries recorded a significant rise – particularly Italy (26%), Spain (23%), Portugal (24%) and Greece (21%).

However, clinical trials are “increasingly moving eastward, particularly to Southeast Asia and Africa”, the study warned.

[By Aneta Zachová, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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