Topic

Articles

A compilation of recent notable news developments that pertain to the clinical trials industry.

News Notes

Perspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies. 

Initial Design Considerations for Immuno-Oncology Trials

Jill Wechsler is ACT's Washington Correspondent

The increasing need for treatments to slow the global spread of COVID-19 has prompted greater cooperation between drug regulatory authorities around the world.

Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.

How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial Research

Bruno Speder is head of clinical regulatory affairs, Clinical Research, SGS Life Science Services, Bruno.Speder@sgs.com.

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

Over the past few years, there has been significant growth in the use of more complex point of care laboratory devices. 

Will Point of Care Laboratory Devices Replace Brick and Mortar Labs in Clinical Trials?

An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.  

RACE for Children Act Starts on August 18

Vice President, Customer Success, Lokavant, Inc.

Understanding how your strategy will be re-shaped post-COVID.

On your Mark…Get Set…Go?...or Go!

In the third of their survey series, Clinical SCORE uncover the specific hurdles faced by site staff and trial participants during the COVID-19 pandemic and the support needed to overcome them.

Following the FDA: Sites Want Flexibility From Sponsors

To overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.

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