IRB

Protocol Feasibility to Promote Trial Efficiency

Scientific abstracts and articles have reported that 20-50% of studies do not accrue subjects at the site level (1-6). This contributes to a significant amount of waste in clinical research, particularly in the forms of staff time and monetary resources. Such waste can be reduced through the careful selection of clinical trials to activate early in the process, before investing a lot of resources. The protocol feasibility review process achieves this by providing a method to review the logistical aspects of a clinical trial prior to starting the activation process.

Study Activation: A Complex Process That Doesn’t Have to Be Painful

Study activation data from the Forte community shows on average, it takes about six months to activate a new, interventional, treatment clinical trial. Long activation periods are not a new trend – in 2008, Dr. David Dilts’ findings showed it took hundreds of steps to activate an NCI-funded trial at a single site. This was just to get the study open to accrual, not to conduct the study. He also found that not all steps added value to the process. To make his point, he charted the study activation process and when he was done, it was 50 feet long by 5 feet tall and in 8-point font! If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.

Are “Virtual Trials” Mainstream Yet?

While some completely virtual trials are taking place, the real trend involves bringing virtual trial components to traditional study designs to improve study efficiency and reduce participant burden.

Medical professionals shaking hands

Botanical Medicines in Research

Learn how IRBs can approach botanical medicine protocols, addressing regulatory landscapes, ethical issues, and research safety.

Special Considerations for Pediatric Trials

Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

Research in Pediatric Populations

Learn about the unique challenges of pediatric clinical trials, including federal regulations, minimal risk, and parental permissions.

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