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. If the results look promising, the trial will move on to the second phase.
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. Again, if the results look promising, the trial will continue to the next phase.
Phase III - The experimental study drug or treatment is given to large groups of volunteers. Researchers continue to collect data to confirm its effectiveness, monitor side effects, compare it to current treatments. 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 will 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 the study. Facilitating accurate clinical documentation, these systems help streamline, standardize and manage budgeting and finance, patient recruitment and management, compliance with government regulations and investigator management. Clinical trial management systems are 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 pharmacovigilance software to monitor drug trials.
- Integration with cloud-based data science technology to improve predictive signal management and catch errors or unknown side effects before they become dangerous.
Eliminating Bias in Clinical Trials
Clinical trails are created to answer specific questions and often overlap. For example, a university trail may seek answers about how to detect a particular illness while a government agency trial about the same illness might seek answers about how to prevent the illness from occurring. A pharmaceutical company's study may seek answers about how to treat the illness, while a medical institution's study might seek answers about how to prevent the illness from re-occurring.
Various strategies are in use to eliminate bias in clinical trials. One example is the use of comparison groups, in which one group might receive the current standard treatment for a condition and another might get an experimental treatment. To eliminate bias, patients are assigned randomly to comparison groups. Additionally, the results of each group can be analyzed side-by-side and no study participants left without treatment.
Another way to avoid bias is masking, or blinding, which involves not telling the trial participants which treatment they receive. Researchers also may not know this information, although this information can be made accessible in an emergency.