COVID-19 Puts Spotlight On Adaptive Clinical Trials

One of the lasting effects of the COVID-19 pandemic is likely to be the accelerated acceptance of adaptive clinical trials.

Dr. Anthony Fauci endorsed adaptive trials when he announced the effectiveness of redelivering in treating COVID-19 patients.

“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover,” Fauci said in a White House briefing April 29.

The data came from a unique type of clinical trial launched in February and sponsored by the National Institute of Allergy and Infectious Diseases where Fauci is director. The Adaptive COVID-19 Treatment Trial (ACTT) is different from classical clinical trials in that researchers can make changes in dosing, patients and other parts of the study as the data accumulates.

That’s why, not quite two months into the study, Fauci was able to declare remdesivir effective in reducing recovery time for COVID-19 patients. Discussing the trial findings up to that point, Fauci said, “What [the trial] has proven is that a drug can block this virus.”

Adaptive clinical trial design is common in testing medical devices, but much less so in testing drugs and new therapies. Those tests are almost exclusively designed as randomized clinical trials (RCT) in which subjects are divided into at least two groups, with one receiving the new drug and a second a placebo. It’s a double-blind test meaning neither the patient nor the clinical researchers know who is getting what. Once underway, only in the rarest of situations can the process depart from the trial’s original design.

Though considered the gold standard for testing the efficacy and safety of new drugs, the RCT design has been criticized for its cost, duration and inflexibility. As long ago as 2004 the Food and Drug Administration announced a Critical Path Initiative to accelerate drug development. “Modernizing Clinical Trial Designs and Strategies” was one of the programs.

At the end of last year, the FDA issued an industry guidance for pharmaceutical and bioscience firms “on the appropriate use of adaptive designs for clinical trials.”

The guidance notes,

“Adaptive designs can provide a variety of advantages over non-adaptive designs. These advantages arise from the fundamental property of clinical trials with an adaptive design: they allow the trial to adjust to information that was not available when the trial began.

While the ACTT, first launched at the University of Nebraska Medical Center and now involving 68 sites, and other adaptive COVID-19 trials now underway are showing they can deliver results, adaptive trials are unlikely to any time soon – or ever — become the new standard for drug testing.

Dr. Adams Dudley, a drug safety expert at UC San Francisco, told the Los Angeles Times, it’s risky to allow companies with a financial stake in the outcome to change study rules during a trial. However, in a crisis like the current COVID-19 pandemic, Dudley said randomized clinical trials take too long.

Noted the Times, “With thousands of people dying every day of COVID-19, the deliberate pace of this gold standard research may not be the best way to end the crisis quickly.”

Photo by Viki Mohamad on Unsplash

#WeAreGreenKey: Spotlight on Emily Gelman
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Emily Gelman

Green Key Unlocked: Why It Pays to be a Paralegal
Accounting + Finance Financial Services General Interest Green Key News Legal Support Worklife

Green Key Unlocked: Why It Pays to be a Paralegal

Perks of a Hybrid Work Schedule
General Interest Green Key News Worklife

Perks of a Hybrid Work Schedule

Green Key Announces New Partners and Principals
Accounting + Finance Architecture + Engineering Financial Services General Interest Green Key News Healthcare Human Resources Information Technology Leadership + Management Pharma Professional Support Worklife

Green Key Announces New Partners and Principals

#WeAreGreenKey: Spotlight on Todd Bernard
Accounting + Finance General Interest Green Key News Human Resources Leadership + Management Worklife

#WeAreGreenKey: Spotlight on Todd Bernard

Employee Benefits for a Supportive Workplace
General Interest Green Key News Worklife

Employee Benefits for a Supportive Workplace

Forbes Names Green Key on America’s Best Temp Staffing Firms 2021
Green Key News

Forbes Names Green Key on America’s Best Temp Staffing Firms 2021

SIA Names Green Key Resources among Largest Staffing Firms in the US
Green Key News

SIA Names Green Key Resources among Largest Staffing Firms in the US

Wrapped Up: 2021 Corporate Trends
General Interest Green Key News Worklife

Wrapped Up: 2021 Corporate Trends

#WeAreGreenKey: Spotlight on Kelsey Kirk
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Kelsey Kirk

Advantages of the “Stay Interview”
General Interest Green Key News Worklife

Advantages of the “Stay Interview”

Green Key Unlocked: What’s New in Architecture, Engineering, & Construction
Architecture + Engineering General Interest Green Key News Worklife

Green Key Unlocked: What’s New in Architecture, Engineering, & Construction

#WeAreGreenKey: Spotlight on Lisa Figuccio
Accounting + Finance General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Lisa Figuccio

Tips for Writing Job Descriptions
General Interest Green Key News Worklife

Tips for Writing Job Descriptions

#WeAreGreenKey: Spotlight on Alexa Perrone
Accounting + Finance General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Alexa Perrone

Tips for Employee Retention
General Interest

Tips for Employee Retention

#WeAreGreenKey: Spotlight on Brooke Stemen
General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Brooke Stemen

Green Key Unlocked: The Value of the MBA
Accounting + Finance Financial Services General Interest Green Key News Marketing Technology Worklife

Green Key Unlocked: The Value of the MBA

#WeAreGreenKey: Spotlight on Amy Raymond
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Amy Raymond

How to Tailor Your LinkedIn Profile for the Jobs You Want
General Interest Green Key News Worklife

How to Tailor Your LinkedIn Profile for the Jobs You Want

Latest Blog Posts
View All Posts
#WeAreGreenKey: Spotlight on Emily Gelman

#WeAreGreenKey: Spotlight on Emily Gelman

Today we catch up with Emily Gelman, Senior Recruiter on the Professional Support team at Green Key. Gelman joined the...
Read More
Green Key Unlocked: Why It Pays to be a Paralegal

Green Key Unlocked: Why It Pays to be a Paralegal

Paralegals are not only imperative to the industry, but recently in high demand. Due to law firms encouraging their entry...
Read More
Perks of a Hybrid Work Schedule

Perks of a Hybrid Work Schedule

The biggest perk of working hybrid is its flexibility. Allowing employees to choose when they come in grants them autonomy...
Read More