Clinical trials are the pinnacles of medical research. Through the last hundred years, investigators have learned best practices and what to avoid. The clinical research trial process is extremely lengthy and thorough, but it ensures patient safety and scientific understanding.
Designing the Experiment
Forming a research question and creating a safe and robust plan to solve it is the first but trickiest step of a clinical research trial. Investigators must also determine their selection criteria and develop ways to screen patient volunteers, including people who are to be in their control group. It’s imperative that patients provide informed consent throughout this entire process.
Researchers must also clearly articulate how they will administer the treatment, what doses they’ll start with, what data they’ll collect, and how they’ll review and analyze that data.
Getting Approval
There are two main ways to get approval before starting a clinical trial. The first is through an Investigational New Drug (IND) Application. The FDA reviews this application to review any relevant data from previous animal or human research, how to make the drug, the research protocol, and background information about the investigators. Clinical trials must also get approval from an Institutional Review Board (IRB) to ensure participant safety and informed consent.
Conducting Trial Phases
After approval, experiments can now begin. These clinical trials can take many years to complete. In general, the steps of a clinical research trial involve exploring different research questions throughout the different phases:
Phase I
- Is the treatment safe?
- What dose is appropriate?
- What are the short-term side effects?
Phase II
- What are the long-term side effects?
- Does the substance work as a treatment for the condition?
Phase III
- Are these results replicable across larger populations?
- How does this experimental treatment compare to the standard treatment?
Phase IV
- What are the effects on different people over time?
- What is the efficacy, or what are the long-term benefits?
- What are the long-term risks?
- How will health providers use this treatment?
Learning the basics of how clinical research trials work is helpful even if you aren’t an investigator or a volunteer.
