Applied Clinical Trials November 2021 Issue (PDF)

The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.

In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.

In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather than technology, and how an antiviral aims to prevent COVID-19 after exposure

Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.

In this video interview, Kent Thoelke, CEO of Paradigm Health, describes how manual eligibility screening and swivel-chair data entry force community sites to trade billable patient care for research, and why that burden is so hard to absorb.

In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients actually experience, and how the FDA expanded a prostate cancer combination to an earlier treatment setting.

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural clinical trials.

Patients don’t experience primary endpoints, so trials that stop at biomarkers and rigid rating scales risk declaring success while leaving daily burden untouched, and digital tools only deliver meaningful evidence when they are co-designed with patients and deployed with restraint.