Researchers at Yale University published research in Molecular Biology and Evolution describing a new molecular analysis approach to quantify DNA changes that contribute to cancer growth.

For years, researchers have been moving towards decentralized clinical trials (DCTs), and in a matter of months, COVID-19 changed the trajectory. Clinical operations teams and investigator sites around the world rose to the challenge and worked quickly to deploy new tactics to serve their study participants. The resulting reward is that DCTs, which can be leveraged smartly to reduce participant burden and improve recruitment and retention, are now becoming more widely adopted in design considerations. But rewards bring about new risks and challenges, and DCTs create new concerns for monitoring participant safety. Dario Lirio – Senior Director, LifeSphere Clinical at ArisGlobal – analyzes the risks and rewards of DCTs.

Novartis announced positive news for patients with metastatic breast cancer. New data showed Kisqali (ribociclib), in combination with the chemotherapy drug fulvestrant, added nearly 16 months of survival benefit to the lives of patients compared to fulvestrant alone. 

As real world evidence (RWE) becomes a more prevalent resource for confirming and expanding product benefit-risk profiles, non-randomized studies (NRS) are emerging as a valuable generator of real world data (RWD). Joan Largent – Senior Director, Epidemiology and Outcomes Research at IQVIA – discusses the findings of her recent study and how researchers can utilize assessment tools for their ability to accurately assess NRS validity.

There is no doubt that COVID-19 has irreversibly changed the healthcare industry, disrupting its previous steady development. Health and safety protocols have rapidly evolved, adapting to new challenges and market demands. To meet pandemic-based shortages, companies needed easily deployable and agile solutions. And who is best equipped to roll out innovations at such a high speed? Startups – it’s them who drive the change.

AstraZeneca said on March 24 the company’s drug Imfinzi, along with chemoradiotherapy, failed to achieve the main goal of improving survival in patients with locally advanced cervical cancer without the disease worsening.

A new position paper from noted thought leaders and the Association of Clinical Research Professionals provides the much-needed voice of the clinical trial professional.

Bristol Myers Squibb’s Opdualag – a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion – was approved by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Merck announced that the company’s proposed treatment Keytruda for non-small cell lung cancer delivered positive results from a Phase III trial. 

In response to the ongoing Russian invasion of Ukraine, Pfizer will cease operations within Russia and proceeds from the company’s subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine. Regarding COVID-19, Pfizer Chief Executive Officer Albert Bourla noted in an interview with Face the Nation that it is likely that a fourth booster shot of the company’s vaccine will be needed to fend off another surge of infections.