Clinical protocols have been growing in complexity over the last several years. And the more complex the protocol, the higher the protocol intimidation factor. If all of the steps aren’t mapped out, visualized and rehearsed in a safe way before patients are enrolled, the risk of deviations becomes much higher after a study begins. To achieve this, someone must cross-reference all the manuals and other documents associated with a protocol, look for pain points and obstacles and get those addressed.

Protocol deviations can cause significant problems during clinical trials, forcing sites and sponsors to direct time and resources toward investigating and addressing them, potentially delaying completion of the study. And failure to address a deviation properly can...

When things go wrong during a clinical trial, retraining of staff is often the go-to response to correct the problem. But rather than using training as a band-aid for every protocol deviation that occurs, organizations would be better served by investing up-front in...

In a world where clinical trials are growing larger and protocols more complex, it’s increasingly important that study sponsors make sure to get their protocols right from the start to avoid unwanted delays or cost overruns due to mistakes, deviations or even just...

Decentralized clinical trials (DCTs), including hybrid studies, have become the latest trend in pursuit of more patient-centric trials. But the full value of DCT methods and technologies may be dependent upon specific patient characteristics and individual site capabilities. Rather than assuming that use of DCT methods is beneficial to all patients, for instance, sponsors and research sites might do better to look closely at their specific patient cohorts to determine what individuals in those groups truly need.

Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But effective enrollment is critical to the ultimate success of any clinical trial, and there...

Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. Despite this, protocol deviations seem to be viewed as just part of...

As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and GCP. In light of this experience, I urge all CRAs and monitors to STOP THE MADNESS of...

Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process — the investigative sites that implement the trials and interact with the patients throughout the process

As part of our series covering all the do's and don'ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research...the requirement to include endless footnotes (in size 6 or 8 font no less!), at the end of the schedule...