EDITOR'S NOTE: This article is an update of a highly popular blog post by Brandy Chittester that was orginially published on February 18, 2014, in GxP Lifeline.
In a scientific experiment, the tighter the controls on the experiment’s variables are, the more accurate and insightful the research’s findings will be. It’s the same case for clinical trials in the life sciences industry. A well-controlled clinical trial that’s rooted in the foundation of the scientific method will produce more reliable data and conclusions.
But how do you define a “well-controlled” clinical trial? Much to the relief of the life sciences manufacturers and their research teams, the U.S. Food and Drug Administration (FDA) provides explicit guidance on what it means to conduct an adequate and well-controlled clinical trial in 21 CFR 314.126.
Let's take a closer look.
What exactly is a clinical trial? According to clinicaltrials.gov, in a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or medical devices, procedures or changes to participants' behavior— for example, diet.
Many of the same factors that make a well-controlled clinical trial for medical devices are similar to what makes a well-controlled drug trial, but there are some fundamental differences researchers need to know.
Key differences between medical device trials versus drug trials include:
Both drug and device trials follow the same requirements when it comes to protecting human subjects, maintaining records and disclosing financial relationships. Those requirements include:
While drug trials are required to follow 21 CFR 312, medical device trials are governed by 21 CFR 812.
Whether it's a drug trial or a medical device trial, the FDA makes it clear that all trials should have the following:
A well-controlled experiment asks a question or a hypothesis. This hypothesis is then tested by the experiment. What characterizes a well-controlled experiment? A well-designed experiment is simple and easily replicated. It maintains strict control on all variables.
The variables in the experiment are designed to prove or disprove a causal relationship between the independent variable and the dependent variable. This would be the drug or device versus the condition of the patient.
Control is a vital element of a well-designed experiment of the main variables. There needs to be a way to rule out the effects of extraneous variables other than the dependent and independent ones.
A good experiment, like a good clinical trial, often has blind controls or double-blind randomization to compare the end results. The goal for a well-controlled experiment is for it to be repeated many times with the same or statistically similar results. Clinical trials are typically not repeated as much as they are designed with large numbers of subjects to remove the bias that could occur on a study with small subject sampling. This helps to rule out random samples or outliers in the “experiment.”
Many would argue there are other things that go into the makeup of a well-controlled clinical trial, especially once sites and patients get involved. Having a research team with adequate facilities, knowledge of the federal regulations, and the time and staff to work on the project are also imperative. Additionally, having timely, well-documented data is vital to the trial's continued success, which helps ensure the trial is being conducted in a way that will produce relevant results.
A well-controlled clinical trial starts with a strong understanding of the risks involved and proper planning to mitigate those risks. Today, it increasingly requires deep knowledge of FDA regulations as well as global requirements like the European Union’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requirements.
Managing the many risks of any trial and keeping it moving forward requires diligent monitoring, record-keeping and seamless coordination between all parties involved.
Finally, as clinical trials wind down, researchers need to ensure they have all the correct documentation in order in their trial master file.
A full-service contract research organization (CRO) with expertise in conducting global clinical trials is an invaluable asset when conducting a well-controlled clinical trial. They can assist with clinical planning and consulting before a trial begins. They can help with monitoring, auditing, project management and safety management during the trial. And they can ensure all your documents are in order as you wrap up a trial so you can obtain approval.
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