| A clinical trial, also known as a clinical research study, is a protocol for evaluating the effects of experimental medical or behavioral interventions on health outcomes. This type of study gathers data from volunteer participants and is typically funded by a medical institution, university, non-profit group, pharmaceutical company or government agency. The goal of a clinical trial is to determine if a new test or treatment works and is safe. Data is presented in terms of trends or overall findings and data anonymization tools are used to protect personally identifiable information (PII) about specific participants. In the United States, strict rules for conducting clinical studies have been put in place by National Institutes of Health (NIH) and the Federal Drug Administration (FDA). Trials are divided into four stages: Phase I - Researchers test an experimental drug or treatment with a small group of volunteers to evaluate the treatment's safety, determine a safe dosage range and identify side effects. Phase II - During this phase, the experimental drug or treatment is given to a larger group of volunteers to see if it is effective and to further evaluate its safety. Phase III - The experimental study drug or treatment is given to large groups of volunteers. Researchers continue to collect data to confirm its effectiveness and monitor side effects. If the experimental drug or treatment is effective and can be used safely, it will be evaluated and potentially approved for use by the general population. Phase IV - Once a drug or treatment has been approved for use by the general population, researchers continue to gather data from the clinical trial participants. Clinical trial management systems Clinical trial management systems (CTMS) are often used to handle the massive amounts of data that is collected and generated during a trial. Such systems facilitate accurate clinical documentation, helping to streamline, standardize and manage budgeting and finance, patient recruitment and management, compliance with government regulations and investigator management. CTMS software is often designed to integrate with other systems, such as electronic data capture and business intelligence (BI) systems. Benefits of a CTMS include: - Executive dashboards to facilitate operations for individual and related studies.
- Reporting and tracking features.
- Data dictionaries to ensure data consistency.
- Integration with cloud-based data science technology to improve predictive signal management
- Integration with pharmacovigilance software to monitor drug trials and catch errors and discover side effects before they become dangerous.
| 
Posts
No comments:
Post a Comment