Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Ok, I take it back that Coronavirus shouldn't slow down studies for life threatening cancers

At Yale University in New Haven, Connecticut, lung-cancer researcher Roy Herbst says clinical trials for cancer have been cut to “almost zero” and are allowed only when a participant is deemed to have exceptional need.

“It’s hard to believe that just a month ago, I’d never seen cancer clinical trials better,” says Herbst, citing a list of experimental treatments that were showing promise against some of the deadliest lung cancers. “Now the whole process has really ground to a halt, and I feel bad because there are patients who might have benefited from those trials.”

...Herbst has had to ask three-quarters of his colleagues in the oncology department at Yale to stay away from the hospital to minimize their risk of infection. Instead, they are held in reserve to treat people with COVID-19 in case the first round of clinicians become infected. Even routine procedures such as biopsies, sometimes required for enrolment in a clinical trial, are now difficult to obtain as hospitals struggle with personnel and equipment shortages.

...Agencies adapt
Government agencies have released guidance for investigators who need to suspend or modify trials. The US Food and Drug Administration, for example, has issued guidance for trials that may have to pause, change their study plans or make do with incomplete data because of the COVID-19 pandemic. Ethics committees are working overtime as researchers file requests to alter their clinical-trial plans in ways that minimize how often participants need to venture into the clinic, says Barbara Bierer, who directs the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard in Boston, Massachusetts.

Agencies and clinical-trial funders have shown remarkable flexibility, says Charles Blanke, an oncologist at Oregon Health & Science University in Portland and leader of the publicly funded SWOG Cancer Research Network. The US National Cancer Institute announced on 23 March that it would allow the investigators it funds to assess trial participants' health remotely where possible. Some doctors’ assessments may be carried out over video calls instead of in person, and some audits of clinical-trial procedures will be conducted virtually, with inspectors examining the paperwork online rather than physically visiting the clinic to assess standards.

The rapid release of these guidelines is a particular relief because many clinical trial sites did not plan for a pandemic like COVID-19,

https://www.nature.com/articles/d41586-020-00889-6/