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:
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.
Clinical Trial Registries
Lundbeck registers clinical trial protocols and discloses the results of clinical trials, regardless of outcome, in a publicly accessible clinical trial registry, ClinicalTrials.gov. Non-interventional studies may also be disclosed if, for example, they are considered to provide important safety data. Clinical trial protocols and results information submitted by Lundbeck to the EudraCT database is made public by the European Medicines Agency (EMA) via its clinical trial registry.
Lundbeck provides open access to clinical trial result summaries (synopses) from Lundbeck-sponsored phase II-IV trials completed after January 1, 2014, with products approved in the EU or US. Find the list of synopses here.
Plain Language Summaries
To support a broader understanding of Lundbeck’s clinical research, and to make our R&D efforts more accessible to patients and carers, Lundbeck has started to create plain language summaries of our clinical trial results. A plain language summary tells what happened during a clinical trial in easy-to-understand language. It includes information about the purpose, results, and other facts about the trial. These are made available to all patients that participate in a Lundbeck sponsored clinical trial in the same language as their signed Informed Consent Form. Lundbeck posts plain language summaries on www.trialsummaries.com.
Clinical Trial Reports
Clinical trial reports for approved products are expected to be accessible on the EMA’s page for clinical trial data in accordance with EMA POLICY/0070. Clinical trial information for products approved in Canada is accessible on Health Canada's homepage in accordance with Health Canada's guidance Public Release of Clinical Information.
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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