The FDAAA Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.
Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.
In October 2017, the watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, grabbed headlines when it filed a lawsuit against the FDA. The suit takes aim at informed consent regulations, seeking to ensure that potential trial participants receive sufficient information to truly evaluate the risks and benefits of participating in a drug trial.
I would guess every researcher has come across a contingency table. Contingency tables are a type of classification table used in statistics to simultaneously summarize relationships between two categorical variables. (Let’s call them Variable X and Variable Y.) Contingency tables are also called two-way tables, cross-tabulation tables (cross-tabs), and frequency distribution tables, because statisticians like to have at least three to five names for everything.
This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.
A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
This requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.
Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.
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Electronic informed consent, or eConsent, is one technological advancement introduced to clinical trials that is escalating in its adoption. In this blog, get 5 tips for implementing and preparing for eConsent.
With the built-in flexibility and control of some eClinical solutions available today, why wouldn't you want to do it all yourself?
With so many choices out there selecting an EDC provider can be difficult and confusing. Follow these tips to avoid getting bogged down in the details and losing sight of what’s really important.
Take advantage of advanced security and compliance services to ensure that users are safe operating in a cloud environment and benefit from the scalability and business continuity of cloud computing.
A unified EDC platform that includes a built-in payment manager ensures efficient, accurate administration of all processes in one central system, rather than jumping from platform to platform.