THOUGHT LEADERSHIP

The objective of phase 1 dose-finding studies is to determine the maximum tolerated dose (MTD), defined as the highest dose at which a pre-specified proportion of subjects experience a dose limiting toxicity (DLT). Ideally, the trial design would not only be easy to implement but also efficient and ethical. In recent years, several statistical models for adaptive trial designs have emerged.

The thinking on monitoring of clinical studies has been changing over the past several years, so now is a good time to reassess the place of SDV and SDR in the operation of clinical trials.

Related, Not Related, Likely, Possibly Related, Unlikely Related, Certain, Definitely, Unassessable, Unknown, Probably Related…if you recognize these terms, then there is a reasonable possibility you are familiar with what the Drug Safety and Pharmacovigilance world refers to as the causality assessment.

One of the great ironies that gives me chuckle in my day-to-day work is the seeming paradox that one of the purposes of the Trial Master File (TMF) is to REDUCE documentation, while in reality, the amount of documentation that goes into a TMF can honestly feel overwhelming.

In March of 2020, when much of the country began to impose lockdowns and restrictions on public contact due to COVID‑19, I was in New York City on the monitoring trip noted in my previous blog. In the ensuing months, the nature of clinical trial monitoring was mostly redefined in an attempt to continue crucial studies and participant care. The following are some of my observations and lessons learned in the aftermath of that experience.