Key clinical trial considerations for the new normal and the future

Image courtesy of Phastar

A great many new and varied approaches to clinical trial management have gained ground during the COVID-19 pandemic through the help of virtualization tools, strong partnerships, and regulatory guidance. Despite the upheaval this year and last, there appears to be a silver lining. The systemic changes have enabled remarkably quick development in adapting trials to accommodate different environments. Additionally, the pharma industry has developed COVID-19 vaccines at an incredible speed. Regulatory guidance has accommodated this abrupt shift. This article will cover the critical factors needed before adapting to patient-centric clinical trials.

For starters, there are quite a few differences regarding attaining and disseminating patient-level data in a decentralized or remote trial setting versus the traditional way an in-person study is designed. Telemedicine or remote visits, for …

Read more
  • 0

Decentralized clinical trials continue to gain ground

[Photo by Laura James from Pexels]

The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients.

And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after shiny objects in many places,” said Dr. Nirav Shah, chief medical officer of Sharecare (Atlanta, Ga.).

The situation is, however, swiftly changing thanks to the pandemic. Some 44% of pharma, biotech and clinical research professionals have already adopted remote patient monitoring (RPM) or plan to do so in the next 12 months, according to a recent survey from VivaLNK (Campbell, Calif.). Almost two-thirds (65%) of survey respondents reported the pandemic was the primary driver of RPM adoption.

Physicians have w…

Read more
  • 0