Badania kliniczne. Praktyka, prawo, etyka

Clinical trials represent the culmination of research and development efforts in the creation of new medicinal products and medical devices. They are a cornerstone of ongoing advancements in the medical field, particularly within pharmacology and high-tech medical innovations. By enhancing treatment standards, they play a crucial role in prolonging and enriching patients' quality of life. All biomedical research and development pursuits, including clinical studies, should foreground patient well-being and needs since patients are the key stakeholders and principal beneficiaries. Moreover, clinical trials are a vital component of a modern, innovative economy. Recently, Poland has seen a rise in the registration of new clinical trials, exceeding 600 annually, while the financial footprint of its clinical research market has grown to over 1.4 billion USD. The book "Clinical Trials: Practice, Law, Ethics" provides readers with a vast array of specific interdisciplinary insights and knowledge pertinent to the execution of clinical trials. Topics range from the exploration of bioethical histories to detailed operational issues, alongside updates on the latest Polish and EU regulations. This edition expands upon the 2015 publication "Clinical Trials" by introducing chapters on data management, biostatistics, personal data protection, partnerships with patient organizations, and conducting research amid crises like wars or pandemics. As authors and editors, we aspire for the book's contents to be instrumental in shedding light on the numerous facets of clinical trial practice, thereby enriching the understanding and capabilities of professionals within the biomedical science sector.