SUNDAY, SEPTEMBER 20, 2020
KARSTEN MIRANDA
Earlier this week, the tally of global COVID-19 deaths crossed 7 lakh. India is now the third country to record more than 2 million coronavirus cases; and the country recently reported the highest number of cases (62,000 +) in 24 hours across the world according to the World Health Organization (WHO) data.
In Goa, it is frightening to hear about the coastal State recording nearly 400 cases in a day; given that experts believe the peak is yet to come.
And as the world is grappling with COVID-19 pandemic, governments are desperately waiting a breakthrough in the search for a vaccine, which will help save lives and curtail the spread of the coronavirus.
Against that backdrop, Goa’s very own Clinton Furtado is part of the leading groups that are performing COVID-19 vaccine clinical trials. The Senior Clinical Research Associate based in England, is presently monitoring processes in UK and Ireland.
While an average, 9 out of 10 vaccine trials fail, currently there are 23 COVID-19 vaccines in the clinic phase and 140 in early development wherein it is widely reported that Oxford Vaccine Trial (OVT) is the front runner.
Optimistically, as per reports, the vaccine could be mass produced and delivered to the public by early 2021.
Presently, there are 2056 recognised COVID-19 trials running, which deal with various arms such as determining the efficacy and safety of a drug, ethical and behavioural aspects of patients, prognosis, treatment, stem cell, psychological effects on COVID-19 patients, etc.
Due to confidentiality reasons, Clinton cannot reveal which trial he is part of, but he does give an oversight of what exactly he does.
Asked if he considers it an honour to be part of such a crucial initiative, he says, “Not just COVID-19, but be it any trial I am working or have worked on in the past, I feel honoured to be a part of it. As I know the drug/vaccine which I am involved in, may go on to improve/save a person’s life. But the true heroes are the volunteers/patients who consent to be on the trial.”
What he does at the trials
Initially, Clinton reviews the clinical trial documents and narrows down the sites, his team needs for their trial by looking at the necessary facilities/ensuring a qualified team/ sufficient patient pool/ quality of source data (patient medical notes/scans/lab tests/etc).
Later, he initiates the site to start the clinical trial by training the doctors/nurses/pharmacists/data managers/study coordinators on the medical protocol, trial systems, expectations of the trial and Good Clinical Practice (GCP).
Clinton specialises in Haematology, Neurology and Oncology trials, but also monitors other clinical trials.
When he is at the trial site (usually hospitals), he reviews the patient source data, discusses the trial with the doctors and brings the team in line with the protocol if any deviations occur
It is very important for him to ensure patient safety and data integrity throughout the trial.
During the clinical trial, he also ensures that the patients are consented correctly, the IP (Investigational Product) is dosed correctly to the patients and all adverse events such as headaches, nausea, etc, are reported correctly
If any serious adverse events such as death/disability/congenital anomaly/birth defect/hospitalisation occur; he needs to ensure all ethical and regulatory bodies have been notified. This is very vital part as every trial needs to stress on the safety aspect of the drug.
Finally, Clinton ends the trial by collating all patient trial data, transferring to the pharmaceutical company and ensuring all confidential patient data has been securely archived on site.
