Clinical Trials Data Management and Analysis
Medical research is a process of gathering data that will expand scientists' understanding of human health. Researchers take steps to ensure the accuracy of all their data, then use sophisticated methods to analyze their findings to ensure the accuracy of their conclusions.
Table of Contents:
How Researchers Use Biostatistics to Analyze Data
How Researchers Protect Data Integrity During Clinical Trials
How Researchers Use Real-World Evidence in Clinical Studies
Continuing Data Collection After Clinical Trials
Learn More About Clinical Trials
Putting together a medical research study is no simple task. Scientists must create a detailed study design that lays out every aspect of the research. This careful process allows the research team to have a clear plan for gathering and using all the data for their research.
Clinical trial data management is one of the biggest priorities in research. Scientists must ensure that study participants understand what the team is trying to learn and what information they will need in the process. Researchers must accurately record data and analyze it carefully to ensure their findings are correct. This requires multiple data management techniques.
How Researchers Use Biostatistics to Analyze Data
Biostatistics is a branch of statistics that deals with data about living organisms. Statisticians analyze data related to humans, animals, and plants to identify patterns. These patterns can be used to assess important scientific information. Biostatistics can also be used to predict health risks in certain groups and give doctors an idea of how different health conditions progress under different circumstances.
In research, biostatistics and clinical data analysis are essential parts of study design and analysis at all phases. Researchers can also use biostatistics when designing a new study. Data from past studies can be used for modeling, pre-study simulations, and feasibility analysis. Preclinical modeling can be used during clinical trials to adapt the study design if needed. Once the study is complete, biostatistical analysis is a key component in writing reports about the study findings.
How Researchers Protect Data Integrity During Clinical Trials
Good science requires good data and good clinical data management. Researchers need to ensure that the information they collect is correct and obtained appropriately. One key step in ensuring data integrity is getting informed consent from study participants. Participants must knowingly agree to all research activities, with sufficient understanding of the potential consequences. Data acquired without appropriate informed consent casts doubt on the study's overall validity.
Once researchers have proper informed consent, all data gathered in the study must be valid, complete, and well-documented. The goal of data gathering and storage is to ensure that the collected information can be used to reconstruct the study and confirm the findings.
Data protection is another aspect of data management. Researchers need to protect participant privacy. They need to have adequate security tools to make sure all data is protected and participants' identities are concealed.
Quality assurance is the process of checking data and data collection methods throughout the trial. This can be done by the research team or quality management experts at the facility where the research is taking place. Government regulators may also conduct audits to ensure all the methods and findings are appropriate and follow best practices.
How Researchers Use Real-World Evidence in Clinical Studies
Real-world evidence is data collected outside the parameters of a study. It can offer valuable insight into how certain behaviors, health conditions, or treatments affect people daily without the rules or oversight imposed by a clinical trial. Real-world data can also offer insights into how particular conditions or treatments affect people over different periods.
Researchers can collect real-world data from various sources, including electronic health records (EHRs), registries (e.g., cancer registries or veterans health condition registries), insurance data, patient-reported data like surveys, or data from mobile health applications and wearable devices.
Real-world evidence can help with designing new clinical trials. The data can be used as a biostatistic to model the potential outcomes of the trial. In some cases, real-world data can replace the placebo arm of a study. Researchers can administer the treatment to all participants and compare study outcomes to real-world data instead of monitoring a control group of participants who receive the placebo instead of treatment.
Continuing Data Collection After Clinical Trials
Data gathering and clinical data analysis continue after a successful study is completed and a new treatment has been approved. Clinical trials are one way of determining a treatment's effectiveness, but they cannot predict all the possible outcomes when people start using the treatment outside the study.
Both researchers and regulatory agencies collect information about how the treatment affects people. This allows researchers to understand the long-term effects of new treatments. It also ensures that regulators identify any unexpected safety issues and take steps to protect people from harm.
Post-market data gathering and management may involve patient reporting systems where people can send information about the adverse effects of treatments to the FDA. Researchers may arrange post-study follow-ups with participants to gather more information about their outcomes over the long term. Researchers may also use real-world data from insurance companies or healthcare systems to understand better how the treatment affects people. This post-market data is another set of biostatistics that can be used to assess current and future research.
Learn More About Clinical Trials
Clinical trials and the medical advances they provide wouldn't be possible without the help of people who participate in clinical research. If you want to learn how you can be a part of medical research studies, connect with Studypages and sign up for our free Pulse Newsletter. Our platform helps you join real clinical studies and take part in the advancement of healthcare research.