Perhaps you are considering joining an Alzheimer’s clinical trial or you are already part of one. The study organizer and site investigator do a good job educating you about the potential trial, but you still have one lingering question. Who is watching out for you? Who is protecting you by making sure the trial is safe and the drug being tested is tolerable? That job falls to an independent safety monitoring committee.
Often called Data Safety Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs), these groups of independent scientists and researchers are brought together by a study organizer to ensure the safety of participants. “The members of the DSMB are independent of the study organizer, the funder, the pharmaceutical company or any other organization involved in the trial,” said Daniel Weintraub, MD, professor of psychiatry and neurology at the Perelman School of Medicine at the University of Pennsylvania.
Dr. Weintraub has served on many DSMBs for studies focused on Alzheimer’s and Parkinson’s research, currently chairing the DSMB for both the Alzheimer’s Disease Cooperative Study (ADCS) and Alzheimer’s Therapeutic Research Institute (ATRI). Dr. Weintraub explained that the DSMB is usually made up of members with broad clinical and statistical experience, and specific knowledge of the disease being studied. They meet on a regular basis (for example, every three months) throughout the study to review safety data for your protection.
“It is our job to give feedback to the study organizer, sponsor and funders about the safety and tolerability of the drug in question,” explained Dr. Weintraub. “If there is a concern, we make recommendations for steps to improve the study, and can even recommend termination of the trial.”
DSMB recommendations could include engaging special consultants, increasing monitoring activities, or adding a new or different review of the data. While a DSMB does not often recommend the closure of a study, it can happen if the data review shows significant safety concerns. The review process is carefully documented to ensure transparency and ethical appropriateness.
“The involvement of a DSMB should give people confidence that there is a group of scientists looking out for their well-being,” concluded Dr. Weintraub. “These independent experts are not invested in the outcome of the trial, only in the safety of the study participants.”
DSMBs are required for most Alzheimer’s drug trials and larger, multi-site studies. If you are considering participation in a trial, be sure to ask about independent safety monitoring. It’s important to understand how your health and safety will be protected.