COVID-19 And Your Clinical Trials

  1. Regeneron’s COVID-19 Trial Reaches Patients In 5 Days 5/12/2020

    AdventHealth’s most serious COVID-19 patients were in the ICU and needed immediate help. When it learned about a clinical trial being conducted by Regeneron Pharmaceuticals, it acted quickly. “We were able to get this trial up and running in a record period of time,” states Dr. Steven Smith. “We signed the documents with Regeneron and were administering the drug to our patients in less than five days.” 

  2. eConsent In Clinical Trials: Insights For Implementation During COVID-19 And Beyond 5/7/2020

    The world has changed in the wake of COVID-19. To adjust, clinical trial sponsors must adapt their protocols, and many are urgently doing so, to provide virtual tools for clinical trial use. One example of an important tool in this space is electronic consent, or eConsent.

  3. Developing A Clinical Trials Strategy For A Post-COVID World 5/4/2020

    It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.

  4. COVID-19 Presents Unique Challenges For Oncology Trials 4/28/2020

    With the COVID-19 pandemic hitting countries around the world, many sponsor companies and sites are scrambling to implement remote monitoring solutions to protect their patients while not disrupting the data collection process. Unfortunately, for oncology patients, some of these technologies are not an option.

  5. Clinical Trials At Home — Implementing Telemedicine & Virtual Visits During COVID-19 4/27/2020

    There is no denying that the COVID-19 pandemic has spurred tremendous — and fast — innovation across our industry. Most importantly, the expansion of telemedicine and virtual solutions is enabling us to meet our patients’ needs while also maintaining patient safety, study integrity, and data quality.

  6. Post COVID-19: Clinical Trials Will Never Be The Same 4/23/2020

    FDA guidance on protecting the safety of patients suddenly has sponsors scrambling for technologies that will allow them to gather patient data without having them travel to hospitals and clinics. Many companies are also contacting IRBs for guidance on modifying protocols to better accommodate patients. I took this opportunity to speak with Donald Deieso, Ph.D., chairman and CEO of WCG, to discuss the current state of clinical trials, and where we can expect the industry to go from here.

  7. An Outsourcing Model Built To Survive Pandemics 4/21/2020

    Drug sponsors put a lot of time and effort into developing their outsourcing model. Unfortunately, a host of unforeseen issues can cause any well-planned strategy to veer off the rails. Accent Therapeutics had the foresight to implement an outsourcing model that allows it to avoid unforeseen operational pitfalls., which helped it minimize disruptions from the COVID-19 pandemic.

  8. What To Expect From The FDA During (And After) COVID-19 4/20/2020

    More than 100 non-COVID-19 trials have been put on hold, and only 14 percent of sites are open for enrollment. This dynamic forces an evaluation of the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.

  9. How To Measure COVID-19’s Impact On Clinical Trials In A Given Country 4/14/2020

    No one knows how the pandemic will unravel and when (if) things will go back to normal. One thing is clear: At least in the next year, research and patient recruitment strategies for current and new clinical trials will depend on the COVID-19 impact on countries and their landscapes. How can we best evaluate what that impact will be?

  10. Despite COVID-19, Patients Are Interested In New Trials 4/14/2020

    Patient-recruitment company SubjectWell connected with sites and patients to learn how the uncertainty of the COVID-19 pandemic is impacting sites and the feelings of patients regarding their participation in clinical trials.