scarlet1967 wrote:
I think the pandemic has forced changes to our ways to get things done. From increasing digital marketing to remote health care and conducting clinical trials among others. They are now suggesting decentralized trials so some information is exchanged through virtual communication and others by home visits. Obviously the pandemic will end at some point but some of these new electronic communications will probably will replace the traditional face to face interactions due to the fact that they are more efficient, less time consuming and costly. Another thing to factor in is late stage cancer patients are very motivated so there will be high compliance to adapt. So again in my opinion absent any updates all we know is their estimates were rather underestimates for the time line as this is an unique trial and the extended duration is based on the fact that they pause few weeks between cycles and gather data. Of course there could be some Covid related issues but I doubt that would explain such a extended time line. On a side note I actually tested positive for covid19 4 days ago now I am triple vaccinated and I have to say apart from mild symptoms in the first two days I feel quite good now. Ontario like US has shortened the quarantine days to 5 to deal with staffing issues. The argument behind it the transmissibility of the infection is reduced by 90 per cent after 5 days. I think eventually we are all looking at some sort of herd immunity and the virus looses it’s strength like omicron and that would be the end of this madness.
“For example, in one fully decentralized registry for Duchenne Muscular Dystrophy conducted by THREAD, participant registration increased 50% in 2020 compared to previous years, driving recruitment for over a dozen clinical trials [15]. The use of eConsent, eCOA, surveys, and remote health solutions alleviate participant concerns while providing sponsors with robust data collection. While studies running when the pandemic struck may have struggled to adjust to changing circumstances, these data suggest a higher degree of resilience for decentralized trials.
These industry trends mirror our experience where we have seen a significant increase in decentralized study interest from both sponsors and CROs. This includes the use of eConsent, telehealth, home health, and remote data collection methods. Studies specifically targeting COVID-19 have incorporated several decentralized elements.
For example, the University of Cambridge’s HEAL-COVID study is a pragmatic platform trial of widely-available generic medications attempting to reduce mortality and hospital readmissions in the post-hospitalization period of COVID-19 [19]. The study takes a hybrid approach with participants recruited and consented on discharge from hospital with a smartphone app to capture ePROs on breathlessness, fatigue, and other symptoms in seven languages, along with analysis of linked real-world data from NHS digital.”
https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2014818