06Jun

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

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Green Key
Jun 6, 2023

Healthcare Dominates ‘Best Jobs’ List

Did you miss the newest release of the annual list of “Best Healthcare Jobs” by U.S. News & World Report?

Coming out just after the start of the new year when so much other news made the headlines, the list of all the “Best Jobs,” which includes healthcare, didn’t make its usual splash. Too bad, because the U.S. News methodology makes it more than a popularity contest, taking into account hiring demand, projected growth, occupational unemployment, pay, and measures like stress levels and work-life balance.

We singled out healthcare jobs, even though the list covers all sorts of industries and occupations because of its dominance. Of the top 10 jobs on the list of 100, 7 are in healthcare. Software developer, as is so frequently the case, ranks first, but right behind are dentist, physician assistant, orthodontist and nurse practitioner.

Registered nurse, often among the top 10 on previous lists, came in 13th. That’s only because the demand for several specialties with higher pay and fewer qualified professionals has grown even larger. Far more nurses are needed by 2028 (371,500) than speech-language pathologists (41,900).

As in-demand as these jobs are, Green Key Resources can help you fill vacancies fast. We know where the best people are and how to reach them. So if you are looking to fill a nursing job or have an opening for a physical therapist or other professional, one call to 212.683.1988 will put you in touch with a recruiting specialist who knows the industry and will work with you to get just the talent you want.

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Green Key
Jun 6, 2023

Technology Is Transforming the Clinical Research Workforce

The clinical research workforce is facing a transformation brought about by the rapid changes in how clinical trials are conducted.

New roles are already emerging, while traditional roles are evolving as decentralization and the technology to support the trend require new skills to effectively manage a trial where researchers and patient may rarely, if ever, meet in person.

new whitepaper from the Association of Clinical Research Professionals details these trends, providing a glimpse at what it means for the workforce and what the industry – researchers and the companies that support them – must do to be ready for the fast arriving future.

“Spurred in part by the ongoing COVID-19 pandemic, [decentralized clinical trials] are bringing more technology to clinical research and along with it the promise of greater efficiency, productivity, and effectiveness,” says Jim Kremidas, ACRP’s executive director. “But to fully realize that potential, roles will need to evolve and operate differently to accommodate this new environment.”

Produced by a group that included representation from technology suppliers, contract research organizations, sites, and more, the whitepaper reached four major conclusions:

  • The majority of clinical trials that implement decentralization, at least in the short term, will be hybrid trials, and aspects of decentralization (e.g. virtual visits) will be leveraged more often and receive more overall acceptance by industry due to COVID-19.
  • Increased use of technology will impact nearly every role. But rather than being a threat to job roles, it will generate the need for the evolution of existing roles and bring unprecedented flexibility and efficiency.
  • New roles likely to emerge include Tech Trainer for CROs, Site Tech Support, Remote Trial Coordinator, Decentralized Investigator, Virtual Patient Guide, and more.
  • Technology training must be standard practice and written into each site manual and delegation log.

In addition to highlighting the growing use of technology – including remote monitoring devices — The Impact of Increased Technology Use on the Clinical Research Workforce defines fully decentralized and “hybrid” trials, discusses the impact of technology workforce roles and details the emerging new jobs.

Photo by Lucas Vasques on Unsplash

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