Research Division
What is a research division?
Our new research division consists of us performing clinical trials to determine the efficacy and safety of new medicines. These trials are crucial steps in the process of bringing a new drug to market. The results of these trials are documented in a detailed report that outlines the findings of the study. This report provides valuable information about the drug’s effectiveness in treating the target condition and any potential side effects or safety concerns that were identified during the trial.
Clinical trials are essential for testing and approving new medicines before they can be prescribed. These trials help researchers and health authorities understand if a medicine is effective, safe, and what its side effects may be. Participation in clinical trials is voluntary and individuals may choose to participate for various reasons, such as helping to advance medical research or gaining access to potential new treatments. Participants receive detailed information about the trial and can withdraw at any time. By participating in clinical trials, individuals contribute to scientific knowledge and the development of new medical treatments.
Every clinical trial follows a detailed plan, similar to a recipe for trial doctors, known as the trial protocol. This protocol outlines who can participate in the trial, the treatment and care participants will receive, the duration of the trial, and how the results will be assessed. Before a trial can begin, an independent ethics committee and local health authorities must approve the protocol. Clinical trials are conducted only when the benefits outweigh the risks for participants and when there is a valid scientific and medical rationale for the trial.
As the trial medicine is a novel treatment, there may be undiscovered side effects. The trial doctor will carefully monitor participants for any adverse effects and ensure they receive appropriate medical care if needed. Strict regulations govern the conduct of clinical trials to safeguard the rights, safety, privacy, and well-being of participants. El Paso Dermatology adheres to all applicable laws and guidelines for clinical trials. Trials are conducted only after approval by national regulatory authorities and research ethics committees.
El Paso Dermatology may utilize the data when seeking approval from health authorities to market a medicine. It can also be used to request updates to the conditions under which medicines are marketed, such as specifying which patient groups can use the medicine. Additionally, the data may be used in reports to health authorities regarding potential side effects of the medicines.
Clinical trial information is safeguarded by the guidelines of Good Clinical Practice and any relevant local data privacy laws and regulations. These measures ensure stringent control over access to the information, maintaining confidentiality to the greatest extent possible.
The findings of a clinical trial are documented in a scientific report intended for researchers, healthcare professionals, and regulatory authorities responsible for approving medicines. This report, known as a clinical trial report or clinical study report, not only includes the trial results but also provides comprehensive details about the trial methodology. To protect the privacy of participants, all information pertaining to them is anonymized in the report, ensuring that no identifying information is disclosed.