by drseckin.com | Posted on April 29, 2021
Endometriosis is a condition in which endometrium-like tissue starts to grow in other parts of the body other than inside the uterus, leading to pain, discomfort, and sometimes infertility .
There is currently no cure for endometriosis. Excision surgery by an expert with considerable ability and experience is considered the “gold standard” for treatment .
There are also several ongoing clinical studies that are testing better ways to prevent, diagnose, or treat the condition .
Clinical studies are of two kinds: interventional trials and observational studies .
Interventional trials involve participants receiving a new medication or procedure. Sometimes, investigators compare this to another treatment or a placebo that does not contain any active ingredients. The aim is to test the safety and efficacy of the new treatment or procedure. Researchers usually conduct interventional trials in several phases. The data from clinical trials can pave the way for approval of new treatments and procedures by regulatory bodies.
Observational studies, on the other hand, do not usually have interventions. Instead, they look into changes in participants over time. For example, they could study the effects of a certain lifestyle in a certain population. Observational studies help in advancing disease knowledge and may be able to identify avenues for future clinical trials.
Clinical trials often happen in successive phases to allow for a comprehensive study of a new treatment or device .
Phase 0: This is the first interventional testing. It is done on a limited number of people. Results from a Phase 0 study establish a baseline to understand the mechanism of action of a particular treatment.
Phase 1: After a Phase 0 evaluation, the trial progresses to the Phase 1 stage. Here, the optimal concentration of treatment that leads to the least side effects is determined.
Phase 2: In Phase 2, the concentration of the treatment is further optimized in the intended patient population. Combinations with other treatments are also considered.
Phase 3: In this phase, the trial enrolls a larger number of participants that are generally randomized i.e. they are randomly assigned to specific treatment groups called “arms”. This is done to minimize any bias in the interpretation of results. While there can be several arms in a Phase 3 trial, the control arm usually receives the current standard-of-care treatment to which the other arms are compared. Results of Phase 3 trials are considered for regulatory approval and therefore, the patients enrolled are monitored very closely.
Phase 4: Trials in this phase involve testing interventions already approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA). They help in understanding any side effects that may be apparent only in larger groups of people.
Enrolling in a clinical trial can be helpful in several ways . These include:
Participating in clinical trials is completely voluntary. However, all trials carry some level of risk. So, it is important to make an informed decision before participating in a clinical trial. Here are some of the points you might want to clarify with the trial coordinator:
Information about past and ongoing clinical trials for endometriosis is available in the U.S. National Library of Medicine’s clinical trials website .
Here, you can find information about the study including the type and phase, start and estimated end dates, eligibility criteria, location of the trial, and available results so far.
Each clinical study has specific eligibility criteria that the team coordinating it decides based on age, gender, and either having or not having a particular disease.
For example, the Research OutSmarts Endometriosis (ROSE) study  seeks to reduce the diagnosis time and discover improved treatments for endometriosis. To enroll in the ROSE study, participants must be non-pregnant, non-breastfeeding women above age 18 with or without endometriosis. Further eligibility will be ascertained after a telephone screen and analysis of menstrual effluents.
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