Velocity Executive Memo Series, Vol. 2
By Dr. Paul Evans | 03/01/2021 |
Velocity Clinical Research
A memo from the Chief Executive and President, Dr Paul Evans
What do teenagers and over 65s have in common?
Until recently, they were both very easy to recruit to COVID vaccine studies. Unfortunately, it’s becoming increasingly more difficult to recruit people over 65 for COVID studies. The opposite is true for teenagers.
Teenagers are easier to recruit than adults
Recruiting for the adolescent trials has progressed very well and ahead of our expectations. So far, over 1,000 volunteers have signed up to the Moderna adolescent COVID vaccine trial we’re running at our site, which is a third of their US study.
Velocity has the secret sauce when it comes to recruiting adolescent volunteers in clinical trials. We’ve been pleasantly surprised because the 12-17 cohort are typically more difficult to recruit as consent is needed from both the patient and parent or guardian. We have been delighted by the response we have seen from respondents of this age group and are having to work hard to keep up with the number of inquiries we are getting.
Word of mouth works very well in this social media-savvy age group who are making their friends aware of the opportunities to participate. Teenagers whose parents took part in the adult studies are also more likely to volunteer, which is particularly helpful when it comes to issues around consent. At one of our sites, both parents and their four children all took part in coronavirus studies. It really was a family affair.
Like the adult trials, teenagers’ motivations are the same - they want to be part of the solution.
Teenagers are eager for things to get back to normal. Kids want to get back to school and athletes are keen to get back to playing fields.
Back to where we started
On the flipside, recruiting over 65s has become increasingly hard. We are facing opposing problems at opposite ends of the age scale because of the vaccine rollout programmes. People think the race to find a vaccine is over, when it’s not.
Over 65s are more likely to have had the vaccine by now, whereas under 18s are much lower in the pecking order. In fact, taking part in a clinical trial is one way to speed up getting a vaccine. When Moderna receives an EUA for adolescents, they will likely unblind and vaccinate everyone in the placebo group, similar to what they have done in the adult trial.
When it comes to volunteer recruitment, we’re back to where we started. And by that I mean, BC. Before coronavirus. The current challenge of recruiting over 65s is a new problem for COVID trials but not a new problem for the industry.
Patient recruitment is the biggest barrier to rapid drug development and has only been made easier for COVID research thanks to increased media coverage. 80% of new drugs are late to market and 50% of this occurs at the trial phase.
However, protocols with an active control – meaning, the vaccine is tested against a previously approved vaccine rather than a placebo – could solve the recruitment problem because volunteers are guaranteed to get an active vaccine. There will always be people who cannot access vaccines easily, especially in countries with complex healthcare systems like the U.S.
Could head-to-head trials be the answer?
Protocols with active controls are common practice. New compounds in an existing drug class are often tested against another licenced product. The difference is that licenced products can be bought in the marketplace, while the supply of the COVID-19 vaccines is quite short. I would expect, for example, Operation Warp Speed to have an influence on this problem. It is, after all, in the national interest to ensure adequate supply for future studies. The government in any country is the customer of these vaccines so they will have a say.
Whilst we haven’t seen a protocol yet with an active control, it can’t be far off, given the number of vaccines that are being rolled out. Janssen is likely to be given the thumbs up tomorrow by the FDA, which could be a gamechanger for the rollout programme, making our job even harder.
I expect we will face a similar problem recruiting teenage volunteers for future COVID studies, if some vaccines get approved for this age group. In many respects, it’s been easier to recruit adolescents than it has adults. Whether this trend continues remains to be seen.