Clinical research is medical research involving people. There are two types, clinical studies and clinical trials.
Clinical (sometimes called observational) studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. LBD studies may help identify new possibilities for clinical trials.
Clinical trials test interventions, such as drugs or devices, as well as diet or lifestyle changes. Drug testing is the focus of many clinical trials.
Clinical trials are the primary way that researchers find out if a promising treatment is safe and effective in people. Clinical trials also can evaluate which treatments are more effective than others.
Before FDA-approved clinical trials begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical Trials and Studies Need All Kinds of People
Clinical trials and studies are a partnership between researchers and volunteer participants, who work together to answer questions we can answer in no other way. To ensure that answers are correct, researchers need volunteers of all kinds: men and women, African Americans, Latinos, Native Americans, Asian Americans, whites, people with Lewy body dementia or a family history of the disease, people with conditions that may lead to LBD, and healthy volunteers.
An intervention may work differently in one group than in another. Without adequate representation of a particular group, questions about a treatment in that group may remain unanswered.
In addition to diversity, the number of people included in research can affect results. Without enough participants, trials may be delayed or produce limited or inconclusive results.
Source: National Institute on Aging/National Institutes of Health, Participating in Alzheimer’s Research