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Q+A: Putting Patient Safety First - The Data Safety Monitoring Board

Wayne Morgan, M.D., DSMB Chairman

Without clinical trials, there is no way to get promising new treatments to people with CF. To ensure that these critically important trials can be completed, and that the safety of those patients who volunteer to participate in them is safeguarded, the CF Foundation created the Data Safety Monitoring Board (DSMB).

Since the Board’s inception in 1999, clinical researcher Wayne Morgan, M.D., professor of pediatrics and physiology at the University of Arizona has served as chair.  Recently, he shared his thoughts with Commitment about his work and the importance of ensuring safety in clinical trials.

What is the Data Safety Monitoring Board?

The DSMB is an unbiased, independent entity whose purpose is to protect the safety and welfare of patients participating in CF clinical trials and to safeguard the integrity of the trial data.  This autonomous board, comprised of more than 50 physicians, scientists, CF specialists, pharmacologists, ethicists and biostatistics experts, serves as a “watchdog” to protect patients and be sure that only good and safe science moves forward. 

Why was the DSMB created?

With the advent of the CF Foundation’s Therapeutics Development Network (TDN), which comprises 18 sites and a coordinating center designed to expedite clinical trials, it became clear that many new clinical trials would soon be initiated.  For this reason, the DSMB was created.    Due to the increased number of clinical trials, the DSMB has almost doubled over the last year.  We now monitor the majority of CF Foundation-funded clinical trials.

Is the DSMB a part of the CF Foundation?

Although the DSMB is funded primarily by the CF Foundation, the DSMB is free from bias toward all studies they monitor.  We take great pains to avoid any conflicts of interest or other biasing factors.  The CF Foundation has very much taken the high road in regards to the DSMB.  They understand that functioning independently is critical to the success of the DSMB and have really been a class act.  It is clear that the DSMB and the leadership of the CF Foundation share the same commitment to superb clinical science and the protection of participants in clinical research.

What is the difference between the DSMB and the Institutional Review Board (IRB) at individual research sites?

The DSMB and IRB are both clinical trial watchdogs in different ways.  This crossover of responsibility provides a double level of security.  The major difference between the DSMB and the IRB is that the IRB does not look at raw data or the quality of the data being gleaned.  The IRB can force trials to be placed on hold or stopped outright if safety problems are found.  The DSMB helps the IRB do their job and facilitates the research going forward.

What role does the DSMB play in an actual clinical trial?

The DSMB regulates the continued scientific validity and merit of clinical trials.  We look at study design and review data from previous studies and preclinical studies to help us give specific recommendations for the current study protocol.  We monitor recruitment rates, drop-out rates and all serious adverse events. Throughout the trial, the DSMB examines accumulated outcome and safety data to make recommendations concerning the continuation, modification or termination of the study.  The DSMB also monitors data quality such as completeness and timeliness, and reviews protocol compliance. 

What are the biggest challenges faced by the DSMB?

Often industry is not used to working with a DSMB.  This concept really began with National Institutes of Health studies.  Safety and study conduct were usually monitored by regulatory groups within pharmaceutical companies.  However, as they realize our commitment to excellence and responsiveness and recognize the expertise we bring to the table, they virtually always end up completely satisfied with the interaction. 

What are the greatest personal rewards that you experience through the DSMB?

The University of Arizona has a relatively small CF center, and we are not able to actively participate in the CF research effort as a research center. So, the DSMB is my way of contributing to finding a way of controlling CF and improving the lives of CF patients.  I enjoy helping to move the science steadily forward through my work with the DSMB. 

I have been taking care of CF patients for 30 years. I have seen many remarkable improvements in that time and have met many incredible people with this disease.  They have truly touched my life, and I am happy to be able to give back by ensuring that they can safely participate in clinical trials and help us achieve our shared goal—curing CF.