Clinical trials are essential to determine whether new drugs are safe and effective when used to treat people.
Carefully conducted clinical trials are performed in patients and human volunteers to provide answers to questions such as:
Does a treatment work?
Does it work better than other treatments?
Does it have side effects?
Deciding to participate in a clinical trial requires careful consideration. In most cases, the therapies investigated in clinical trials are not yet approved by regulatory agencies and the benefits and risks of taking the treatment are not completely known. However, regulatory agencies and ethics committees have approved the conduct of the clinical trial. By volunteering for a clinical trial, you are helping the medical community determine whether new treatments are safe and effective.
Lundbeck registers clinical trial protocols and discloses the results of clinical trials, regardless of outcome, in a publicly accessible clinical trial registry, ClinicalTrials.gov. In addition, clinical trial protocols and results information submitted by Lundbeck to the EudraCT database is made publicly available by the European Medicines Agency (EMA) via its clinical trial registry.
Clinical trial reports will be accessible on the EMA’s page for clinical trial data in accordance with EMA POLICY/0070. Clinical trial information will also be accessible on Health Canada's homepage in accordance with Health Canada's guidence Public Release of Clinical Information. Non-interventional studies may also be disclosed if, for example, they are considered to provide important safety data.
Lundbeck will seek to ensure that disclosure of clinical trial information follows the IFPMA, EFPIA, JPMA, and PhRMA joint position paper “Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases”, the Declaration of Helsinki, and other relevant clinical trial disclosure requirements.
Lundbeck respects the privacy of the relationship between patients and healthcare professionals and is committed to ensuring that the process of scientific publication and clinical trial data sharing do not breach patient confidentiality.
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