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Home » Authors » Suz Redfearn

Suz Redfearn

suz.redfearn@centerwatch.com
Articles

ARTICLES

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New Trial Designs Needed to Make Accelerated Approval Work, FDA Leaders Say

October 3, 2022
Suz Redfearn
Sponsors of cancer drugs seeking FDA’s accelerated approval (AA) should use trial designs that show clinical benefit in an early stage rather than following the traditional three-phase model and waiting to initiate a confirmatory trial after AA is granted, recommend several FDA Oncology Center of Excellence (OCE) officials. Read More
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What a Califf-Led FDA May Look Like the Second Time Around

December 6, 2021
James Miessler and Suz Redfearn
If Robert Califf’s nomination to helm the FDA a second time succeeds in Congress, he is likely to push for clinical research reforms, with a focus on diversity, the increased use of real-world evidence (RWE) and addressing the rising costs and complexity of trials. Read More
Wearables technology

Driving the Use of Wearables in Trials: Technology Advances, Regulatory Support

May 4, 2021
Suz Redfearn
Advances in technology and data management, as well as increasing support from regulators, are fueling the use of wearables in clinical trials, along with sponsors’ increasing realization that the data they collect from patients’ daily lives is often better than what they can collect at sites. Read More
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2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

January 25, 2021
Suz Redfearn
Trials of COVID-19 vaccines, along with research into variants of the SARS-CoV-2 virus that causes the disease, will dominate the vaccine development space through 2022, with some nonCOVID vaccine trials slowly trickling back after being delayed by the pandemic. Read More
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COVID-19 Not the Only Factor in Trial Industry’s Outlook for 2021

December 8, 2020
Leslie Ramsey and Suz Redfearn
As the clinical trials industry looks back on what has been an incredibly disruptive year, questions are being raised about what to expect in 2021. One thing is certain: a return to normalcy is not in the cards although there is cause for hope about how COVID-19 has altered the clinical trials landscape. Read More
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Independent Sites Can Increase Accounting Efficiency with Best Practices

July 20, 2020
Suz Redfearn
Independent sites without the time, staff or accounting experience to keep a close eye on sponsor billing and payments can avoid losing thousands of dollars by instituting a few best practices to help keep the cash flowing. Read More
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Pandemic Prompts Trials to Reinvent Themselves, Woodcock Says

April 27, 2020
Suz Redfearn
COVID-19 should come as a prompt to the clinical research sector to rapidly reinvent itself as it works to design and launch clinical trials for vaccine and therapeutic candidates “in the teeth of the epidemic,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. Read More
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Precision Medicine Trials Rely on Data Integration, Survey Shows

March 6, 2020
Suz Redfearn
Designers of precision medicine trials need access to more data sources than traditional trials to refine the parameters of their studies and boost enrollment. Read More

Risk-Based Monitoring: Widespread Implementation is Underway, but Still Messy

July 9, 2018
Suz Redfearn
The industry has been abuzz about risk-based monitoring (RBM) for much of the last decade, with the FDA indicating that it would like to see more sponsors give it a try. Read More

Research Projects Show Credentialed Principal Investigators and CRCs Perform Better

July 2, 2018
Suz Redfearn
The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. Read More
View All Articles by Suz Redfearn

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