Dr Nikita Kherodiya (MBBS, MPH) is a RESULTS volunteer in Sydney. She works for an Australian-based clinical research company where part of her role involves running vaccine trials for vaccines against COVID, different treatment modalities for eczema and osteoarthritis, to name a few. The COVID vaccine trial is one of the largest study trials being undertaken here for an overseas company. She spoke to RESULTS’ Policy Advisor (Child Health), Michelle Imison, about her work.
What are you working on at the moment, Nikita?
Currently we are working mainly on COVID vaccine trials but side by side also working on different trials of an osteoarthritis treatment, an eczema study and a few more.
Tell me about a typical day at work for you.
It’s a bit difficult to say it step by step but generally it involves meeting the patients, explaining them what the study is about, after that it’s the PI (the Principal Investigator is the person leading the research trial) who takes the consent of the patient before progressing ahead and then starts the screening procedure for a patient. This includes the Inclusion & Exclusion criteria then the screening blood tests and especially for this COVID vaccine, a swab is also a screening procedure to test every patient for COVID. (Inclusion and exclusion criteria determine whether or not someone is able to participate – for example, if they were found to already have COVID or another respiratory illness, they would be excluded from the trial.)
As it is a double-blinded study, and I am part of the blinded team, I can speak less on the division of placebo and the SARS CoV Vaccine. (A double-blind study is one where both the vaccine recipients and the people conducting the trial are ‘blind’ to – i.e. do not know – whether participants are receiving the test vaccine or the placebo. Double-blinding is one of a set of measures considered ‘gold standard’ in the conduct of clinical trials, and aims to ensure that the trial is able to demonstrate that any protective effect observed is being caused by the vaccine being tested, and not by something else.)
There is a lot of hope that a COVID vaccine will be ready within months – if this were to be the case, it would be a record! How long does a vaccine generally take to be approved?
The process of making a vaccine is very long, and the usual timeline is approximately 24-36 months. But in this difficult situation, everyone is trying their best to make it a quick process. This vaccine is being tested in around ten countries. As it has to go through the process of approval from the ethics committee, progress through the FDA approval and then come to the Phase 1 trials (tests conducted purely in the lab) all the way till Phase 3 (tests conducted on humans) and then the evaluation of overall results, which makes it all a long process. (The FDA is the US Food and Drug Administration; among its other responsibilities, the FDA protects public health by ensuring the safety, efficacy and security of human and veterinary drugs. Administering any type of medicine when it is cross border requires FDA approval.)
What kinds of people volunteer to take part in vaccine trials? What motivates them?
Mainly it’s word of mouth and the people we have recruited are through our PI who is a GP and also through the word spread by the team. We have met really amazing people who just want to do it so that everyone else can get out of this madness called “COVID”. Sometimes I just wonder about all the goodness around us.
Vaccines have been in the news a lot lately and the general public knows much more now about how trials are conducted, but we still aren’t experts. What’s something you wish the public knew, but doesn’t, about the testing and approval process for vaccines?
Sometimes, this work is overwhelming as everything related to Coronavirus is new, and everyday there are new developments in the studies associated; with new amendments coming our way every day and changes being made by the principle company based on the FDA queries, it’s a tedious process.
As the recent pandemic has made the public more aware of research, but there are still so many questions associated with how an actual clinical trial works, it will be really good if they could know that it takes a huge amount from a lot of people; also it’s an important part of the medical field, as they are the new way to detect and prevent and treat diseases and the need for more dedication towards clinical trials is needed so as to improve the situations of various diseases and determine the safety of a new treatment.
Thanks for your time, Nikita, and for the work you and your colleagues do toward keeping us safe and well!