LAM Clinical Trials
What is a Clinical Trial?
A clinical trial is a research study to determine whether experimental therapies are safe and effective under controlled environments. The U.S. National Institutes of Health states on its website that "carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health."
A Data Safety Monitoring Board (DSMB), an independent committee set up specifically to monitor data throughout the duration of a study, is used to determine if continuing the study is appropriate, both scientifically and ethically. The establishment of a DSMB is required for multi-site clinical trials involving treatments that entail potential risk to the participants.Why Participate in a Clinical Trial?
There are many reasons to take part in a clinical trial, namely: access to either the best standard of care or a promising new treatment, close monitoring by the treatment team and the opportunity to help advance knowledge and treatments for future patients. Clinical trial participants are given individual attention and followed very closely by the treatment team. This may mean more frequent appointments with the researchers, as well as the patient's primary doctor.
Depending on the location of the trial, patients may receive care at a large treatment center, a university or local hospital, medical center or physician's office. Wherever the clinical trial is conducted, strict federal guidelines regulate clinical trials by requiring independent committees, called Institutional Review Boards (IRBs), to oversee the trial. Each study has an action plan, also called a "protocol," and IRBs approve this plan to ensure that participants are not exposed to any unnecessary risks.
Participants also are provided with "informed consent," which is how researchers provide explanations and updates about the trial, allowing participants to make informed decisions about entering a study. To give their informed consent, patients sign a document that details the study and their rights. Participation in a clinical trial is voluntary, so a patient can change his or her mind at any point for any reason.
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