ARTICLES BY ED MISETA
Four Steps Sponsors Can Take To Increase Patient Recruitment
There are many reasons for the low percentage of patients who opt to participate in clinical trials. Many do not know trials exist, most physicians do not refer their patients to trials, and even when a patient becomes aware of these studies, misconceptions and the burden of trials can be enough to steer them away.
Pets, Perseverance, And Manufacturing Facility Bring Biotech Success
Patricia Lawman, cofounder and CEO of the biotech firm Morphogenesis, has always been amazed at how our bodies can defeat illnesses and usually do it better than drugs. “In my younger days, it seemed the only things we had available for most diseases were drugs that addressed the symptoms of a disease, not the disease itself,” says Lawman. “I often wondered why we couldn’t figure out a way to help our bodies do what they do best — maintain health and fight disease.”
FDA: We Can Speed Drug Development With Tech Innovation
In March 2020, the COVID-19 pandemic began to shut down normal day-to-day activities in the U.S. No industry was spared, including drug discovery. During her keynote address at the 2020 Veeva R&D Summit, Amy Abernethy, principal deputy commissioner & acting CIO for the FDA, discussed how the agency responded.
How Has COVID Impacted The Clinical Trial Pipeline?
As we come to the end of 2020, the world remains focused on finding a vaccine that is effective at halting the spread of COVID-19. The pandemic is already responsible for the deaths of over 1 million people worldwide. In 2020 it also resulted in the cancelling or delay of numerous non-COVID trials for other important medications.
AMO Pharma Works With FDA To Advance CNS Trials
When COVID-19 began to impact trials in March 2020, sponsor companies began a search for patient centric approaches that would facilitate continued participation. AMO Pharma was no exception. In fact, because of the condition of the patient population, it was even more vital to keep them safe.
AI Helps BioXcel Meet Unmet Medical Needs
Many companies are currently looking for pipeline or commercialized drugs that could be effective at treating the symptoms of COVID-19. BioXcel Therapeutics uses a similar approach. By targeting drugs that have already reached clinical testing, the company’s approach is expected to lead to a faster development cycle for unmet medical needs.
An ALS Trial Changes The Patient Recruitment Paradigm
Kent Leslie, CSO for Amylyx, refers to patient recruitment as the bane of most clinical studies. As is the case in most trials, recruitment for the CENTAUR trial was slow. Although multiple companies competing for the same patients was a likely factor, Leslie also felt a change was needed in the recruitment paradigm.
A New Patient-Centric Virtual Trial Targets Rare Cancers
The TargetCancer Foundation, with support from Bayer, has launched a study to research genomic testing in people with rare cancers. The study, called TRACK (Target Rare Cancer Knowledge), has already enrolled the first patients in the U.S. Those patients have been diagnosed with rare cancers, including those with cancers of unknown primary (CUP).
COVID-19 Changes Protocol For Alzheimer’s Clinical Trial
When Amylyx Pharmaceuticals began its PEGASUS trial for patients with Alzheimer’s disease, it had no idea the trial would be disrupted by COVID-19, or that the pandemic would necessitate taking the trial to patient’s homes. Yet that is exactly the situation the company had to deal with.
New Playbook Helps Sponsors Implement Digital Technologies In Trials
Companies interested in implementing digital devices into trials now have a reference source for information. The Playbook is a new tool developed by DiMe (Digital Medicine Society), Elektra Labs, Koneksa Health, Genentech, MyoKardia, Sage Bionetworks and Scripps Research. It is being billed as the essential industry guide for successfully developing and deploying digital clinical measures across clinical research, clinical care, and public health.