In their efforts to reduce the chances of people being exposed to COVID-19, a growing number of medical centers around the globe have started restricting nonessential visits, including those necessary to conduct clinical drug trials.
In light of that, and to avoid unnecessary risks, biotechnology giant Amgen (AMGN 0.22%) recently decided to pause enrollment and screening of clinical trials wherever safety and data integrity could become an issue.
In a recent update regarding its COVID-19 pandemic strategy, Amgen outlined the basic principles that will guide its drug development activity over the next several months. Studies of treatments that could provide evidence of a life-saving benefit to patients who lack other options will continue as long as registered trial sites can safely enroll and monitor patients.
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Patients already enrolled in trials will continue to receive drugs being studied, and Amgen thinks its most important late-stage trials will complete without disruption. A potentially pivotal phase 2 lung cancer study of AMG 510 is already fully enrolled, as are phase 3 studies of a potential new asthma treatment called tezepelumab and a heart failure candidate called omecamtiv mecarbil.
At the moment, Amgen has 22 experimental treatments for cancer, cardiovascular disease, obesity, and inflammation in phase 1 trials. Since these are mostly first attempts to gauge a drug candidate's safety and potential toxicity at various dosages, those studies will probably be delayed indefinitely.
Patients relying on Amgen drugs that have already been tested shouldn't have to worry about shortages. The company says it doesn't expect any interruption to its supply of approved medicines.
