What research is being done to find treatments or a cure for MS? This question is of great interest to those with MS and the people who love them. To read and understand reports about current MS research, or if you are considering participating in a study, it is first helpful to understand how research studies are designed, conducted, and validated.
There are two main categories for human research: observational and experimental studies.
Here, researchers follow a group of people in order to gather data about them. They do not interact with or influence the participants in the study; they simply observe them and collect information.
Scientists use observational studies to identify various differences or common threads, such as risk factors or positive effects, found within the group of participants.
There are several types of observational studies, including:
Here, researchers introduce a variable – such as a drug, medical device, or therapy method – to a group and measure its effects. The results are compared to a similar group who are either not given the variable, or are given a placebo version. This group is known as the control group.
Scientists use experimental studies to learn about the effects, and potential effectiveness, of treatments. Experimental studies in the field of medicine are frequently referred to as clinical trials.
There are several types of experimental studies, including:
Research begins with extensive planning. A study must be well designed to ensure the necessary information is gathered to reach a clear, unbiased conclusion. Poorly designed research can give misleading results.
For drugs and medical devices, the process then moves to a stage known as preclinical research, where laboratory tests are performed. The goal of preclinical testing is to determine whether the treatment has the potential benefit to merit being tested on humans, and minimize the risk in doing so. In this stage, drugs are tested on living cells and/or animals. This testing is meant to determine what specific changes the drug triggers inside an organism, and whether the organism changes the drug in any way, as well as any potential for toxicity.
Before research can be conducted with human participants, the design of the study must be approved by an independent committee that examines the ethics of the research. This committee, typically known as an Institutional Review Board (IRB), seeks to ensure that the potential benefits outweigh the risks, and that appropriate measures are in place to protect the participants.
When a study is approved to proceed, the researchers' next task is to recruit and enroll participants. They will share inclusion and exclusion criteria. In order to be enrolled, a person must meet the inclusion criteria, which specify what kind of participants are needed, and not meet the exclusion criteria, which identify factors that make a person ineligible.
Those who are enrolled are next provided with information and an opportunity to ask questions. The researchers must make certain that the participants fully understand the study and what will be done to them. This process is called informed consent, and participants must sign forms that indicate they understand how the study will be conducted, what their rights are as a participant, and what risks are associated with their participation.
Some trials, particularly those evaluating new drugs, are conducted in phases.
When studies have shown that a treatment is safe and effective, researchers assess whether it requires regulatory approval to proceed. Studies on new therapy protocols, such as a specific diet or behavior modification, are typically published in peer-reviewed journals and taught in continuing medical education before being implemented. But new drugs and certain medical devices will require approval by the U.S. Food and Drug Administration.
When a treatment requires FDA approval, the developer of the product will submit an application with the accompanying research. That information is reviewed by a panel of experts in a process that can take 6-10 months. At times, the FDA will agree to speed up the review process, if the treatment is designed for an unmet need or represents a significant approval over the treatments already available.
To learn more about clinical trials, or if you are interested in participating in research please check our Clinical Trials page