What is a clinical trial?
A clinical trial is a research study that explores whether a medical treatment or device is safe and effective for humans. It plays a critical role in the process of bringing new therapies to patients.
Trials conducted during clinical development generate thousands of pieces of data that are generally used by regulatory agencies to determine approval for use of the therapy and indications.
Our commitment
Menarini Stemline® UK is committed to the appropriate disclosure of information from its clinical trials. We believe that making protocol information and clinical trial data available to researchers, healthcare professionals, patients, academics and others, in appropriate formats, advances science and medicine. These interactions hold promise for the improvement of public health, increased knowledge and deeper bonds of trust.
We disclose information from our clinical trials through registration and postings on widely-accepted public clinical trial registries, in line with our corporate commitments as well as international and national regulatory requirements and disclosure norms established by global and regional pharmaceutical industry associations.
Phase 1–4 clinical trials are disclosed in Clinical Trial Registries, which are accessible to the public free of charge in line with applicable regulations. Each registry contains adequate trial information to inform prospective clinical trial volunteers, healthcare practitioners and the general public of the clinical trial title, design, identification/registration number, description and purpose, medical condition or disease being studied, key eligibility criteria, recruitment status, trial sites and contact for information on enrolment.
In addition to publishing clinical research routinely in scientific journals and collaborating with academic researchers, Menarini Stemline® UK also comply with applicable regulations and the principles set forth by the European Federation of Pharmaceutical Industries Association (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) to share clinical trial data responsibly upon formal request and approval by an independent review panel.