Velocity Executive Memo Series, Vol. 1
By Dr. Paul Evans | 02/01/2021 |
Velocity Clinical Research
A memo from the Chief Executive and President, Dr Paul Evans
When my colleagues and I heard the Moderna, Pfizer and AstraZeneca vaccines had all received EUAs in the U.S. and Europe last year, as humans we felt relief, and as professionals we felt pride, having worked on all three studies.
In fact, Velocity Clinical Research is the only North American site company to have worked across all COVID-19 vaccine studies in the U.S., including all six funded by Operation Warp Speed. In a matter of months we had recruited thousands of volunteers. This unprecedented rate of patient recruitment is a big part of why the vaccines were approved so quickly.
So when I’m asked, what do people still need to know? I have three answers for them.
Firstly, our work here is not done.
It is fantastic to have three vaccines already approved, but if we are going to limit the spread of this virus in the U.S., let alone the rest of the world, then we need more than two or three vaccines.
Having more options that use different scientific approaches will alleviate the pressure for the same raw materials. There are also different vaccines in the pipeline that can be more easily administered. For example, both an oral vaccine and a nasal spray are in mid- to late-stage development and testing.
We need more volunteers for studies that are only just entering the phase three stage - in my estimation, well over 150,000 people in the U.S. alone.
Secondly, the diversity genie cannot be put back into the bottle.
Normally, recruitment of minority populations is a problem within clinical research. Most volunteers tend to be caucasian. The clinical research industry is notoriously conservative, and by that, I mean slow to adapt to new ways of doing things. For example, when I was attending conferences in the 90s, the topic of diversity was on the agenda.
Getting new drugs to patients, who are in desperate need of them, has been prioritised over diversifying the dataset that the research is based on. 80% of drugs are late in getting to market and 50% of that occurs at the testing phase.
The experience of finding a COVID vaccine and the increased media scrutiny on diversity within clinical research has been a positive force for change. The industry is seriously looking at how it can make patient recruitment more inclusive.
It’s not a simple problem with a simple answer. There are cultural issues of trust in some communities, and there are also more practical issues. Existing research sites, for example, may not be conveniently located to predominantly minority populations. The time and cost of travel can be a very real disincentive.
If we locate sites close to those who want to participate in clinical research, they will take part. For example, we have a site in Florida where the entire staff speaks Spanish and seventy-five percent of the COVID study volunteers are from the Latino community.
We are also looking more closely at diversity among our workforce and have hired people in outreach roles to build trust with communities and raise awareness of the work we do.
Finally, we need to make clinical trials more accessible to everyone.
Before 2020, only 5% of the population took part in clinical research because of lack of awareness. If there has to be some good from some bad, it’s that more people are aware of how they can get involved in the advancement of science. I have the media to thank for raising awareness of clinical trials. Never in my 30 plus years’ career did I think I’d see my industry on CNN.
The restrictions COVID imposed on everyone in 2020 forced us to be creative with how we conduct trials. At the beginning of the year we had research in progress that needed to be completed. At one point we did patient follow-up appointments on volunteers’ front porches, so we could remain socially distant. There is now much more interest in conducting “decentralised clinical trials” where there is more flexibility in the way patients can complete study visits.
During the COVID studies, we added significant square footage, bringing our total site footprint to the equivalent of a Manhattan block. We also employed new technology to conduct visits and monitor patients, which has provided greater flexibility for both us and our volunteers.
We’ve come a long way in fighting this global pandemic but we have some dark months ahead of us. I estimate we still need roughly 150,000 volunteers across the US to participate in ongoing COVID vaccines studies. Hopefully I can be writing a post this time next year to say we finally did it.