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Ethical Approaches

Despite the continuous development of new treatments, availability of efficient and safe methods remains a great unmet need. This term, ‘methods’, refers to the vast range of approaches to chemical and biologic medications, cell-based therapies, medical devices, psychotherapy and so on. Testing new procedures against placebo is thought to provide the most reliable data on the value of a new solution.

However, it is not unusual that this comparison is unfeasible for technical or practical reasons or because it is considered unethical. The latter especially affects the development of treatments for severe diseases or for vulnerable populations, where the use of a placebo instead of an active comparator or standard-of-care may be dangerous for the subject. In some cases, the use of placebos can also be linked with a risk to other people, for example, due to an increased possibility of aggressive or asocial behaviours.

These considerations have fuelled many years of debate over the use of placebos in clinical trials. Regulators, opinion leaders, patient advocates and journalists express their opinions on this matter – noticing a disagreement between the stakeholders is easy.

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Dr Piotr Piotrowski is a Medical Director at KCR and holds a PhD in neurology. He is responsible for cross-therapeutic oversight of new and ongoing company projects from a medical perspective. Piotr’s professional experience includes more than 10 years in medical affairs, preclinical research, clinical development and regulatory affairs in the environment of the world’s top pharma industry and academic entities.

Dr Magdalena Czarnecka is a member of the Commercial Project Support Team at KCR, responsible for landscaping and development of clinical documentation. She gathered her professional experience during preclinical research at Georgetown University in Washington DC, US, and her work for a consulting firm focused on medical technology assessment. Magdalena holds a PhD in physiology and biophysics.

Dr Anna Baran
is a Chief Medical Officer at KCR. She leads the organisation’s early stages of study operations and provides cross-functional support to all service areas, ensuring the smooth integration of medical affairs and regulatory and business development efforts. Throughout her career, Anna has worked closely with recognised authorities across Eastern Europe and has been involved in developing national legislation for clinical trials registration.
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Dr Piotr Piotrowsk
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Dr Magdalena Czarnecka
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Dr Anna Baran
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