- The protocols to start the clinical trials
- Volunteers are selected and monitored
- There is a Data Safety Monitoring Board (DSMB) overlooking the trial
- WHO Solidarity Trials will run for 18 months; Sputnik V Trials will run 3 to 6 months
- Some 1,000 Filipinos will be part of Sputnik V Phase 3 clinical trials
The numbers related to the coronavirus disease (COVID-19) pandemic are alarming: about 29 million cases around the world with a death toll of 917,000, according to the World Health Organization, as of Sept. 14. Add to that the WHO also recorded 307,930 new cases in 24 hours around the world, the highest number of new cases so far.
As the numbers continue to rise, scientists and researchers around the world are working tirelessly to produce a vaccine, many of them now in the final stages of the clinical trials.
What is the process of getting the clinical trials conducted, how are participants selected, and what happens during the period of the clinical trials? Here’s a look at the processes now ongoing in the Philippines and in many parts of the world on the way to producing a safe and effective vaccine against COVID-19.
First, approval from the FDA
All candidate vaccines must undergo a regulatory process before it can be tested in the country.
DOH Undersecretary Mario Rosario Vergerie said approval from the Food and Drugs Administration (FDA) and ethics review board must be secured first before the conduct of any vaccine trial whether by local or international sponsors or developers.
“The government needs to regulate so that we can ensure that it will be safe for our countrymen. If we do not go through this process, we cannot be sure that it is safe and it might cause harm to our citizens,” Vergerie said in Pilipino.
The approval of a trial application would take 45 to 60 days, Jesusa Joyce Cirunay, head of FDA’s Center for Drug Regulation and Research, said.
Recruiting volunteers
Dr. Jaime Montoya an infectious disease expert and Executive Director of the DOST – Philippine Council for Health Research and Development (DOST-PCHRD) explained the system for the recruitment of volunteers for clinical trials. He said that is based on selection criteria related to the protocols set by the vaccine developers. That also serves as a guide to the characteristics of volunteers who will participate.
“Meron silang mga target na age groups, puwede din kasing makita doon kung anong mga klase ng tao ang kanilang target, halimbawa pwedeng healthcare workers, mga frontliners, mga nagtatrabaho sa ospital o pwedeng mga nasa komunidad (They have a target age group, or the type of persons required — if a healthcare worker, frontliner, hospital worker or just a person within a community),” Montoya explained.
He explained that what is important is that selection is not at random.
It is also important that there should be an informed consent (FPIC).
“Ipapaliwanag sa mga lalahok kung ano yung clinical trial, yung ano yung produkto, ano yung posibleng epekto nito, bakit ito ibinibigay, at ano iyong maaaring mangyari kapag ika’y lumahok (It is explained to the participants what the clinical trial is about, the product, possible effects, the reason why it is given, and what will happen during the trials),” Montoya said.
Montoya emphasized that participation in the clinical trials is voluntary. If they agree, they sign and join.
Compensation
Are volunteers compensated for joining the clinical trials?
Dr. Montoya said that they are given a small amount for food and in some cases transportation when they need to go to an area far from their residences.
“But we need to keep in mind that this amount is not huge. This is to avoid people from taking part without fully understanding the meaning behind their participation and may only be doing it because of the money,” Montoya explained.
“That’s what we call, “undue inducement” and we don’t want that to happen,” Montoya said.
The clinical trials
Dr. Lulu Bravo, executive director of the Philippine Foundation for Vaccination said that the people involved in the trials will be monitored from the time they are given the vaccine up to five years after, depending on safety concerns.
“There is a Data Safety Monitoring Board (DSMB) overlooking the trial and they can stop the trial anytime if there are concerns, or continue the trial after certain numbers have been enrolled,” Dr. Bravo said.
The World Health Organization Solidarity Trials, which has yet to announce the vaccines to be used, will run for 18 months while the Phase 3 Clinical Trials of Sputnik V, the Russian vaccine, will run for three to six months.
The Solidarity Trials and the Phase 3 Clinical Trials of Sputnik are different in method and scope.
According to Department of Science and Technology Secretary Fortunato dela Pena, an estimated 1,000 participants are required for the WHO Solidarity trials since about 80 countries will be part of it. The Philippines is participating in the Solidarity trials.
Sputnik, the Russian vaccine candidate, will be conducting Phase 3 clinical trials to test efficacy and monitor adverse reactions. There will be about 1,000 Filipinos who will be part of the Phase 3 clinical trials.
Dr. Bravo, who has been part of conducting vaccine trials in the country for 30 years, said that there had been no case of a participant who died during a vaccine trial.
“There is always a liability clause in the informed consent that every volunteer signs before the trial…there is insurance… dependent on DALY and age etc,” Dr. Bravo said. (Disability-Adjusted Life Year (DALY) is the computed amount of life years and income a person loses if he becomes disabled.)
“People who have been in vaccine trials usually ask when the next one will be so they can get their friends and family included. In other words they’re happy that they were taken care of and given top quality care during the conduct of the trials,” she added.
Foreign policies on clinical trials
China is currently testing 16 different vaccine candidates, according to data from the London School of Hygiene and Tropical Medicine. Following China is the United States with 11 ongoing trials, and Russia with six.
According to the National Institute of Allergy and Infectious Diseases (NIAID)’s ClinRegs’s website, clinical trials in China a vaccine trial must first undergo a regulatory authority and ethics committee review before they are conducted.
A clinical trial approval in China takes 60 business days, according to the Backer McKenzie Clinical Trials Handbook (Asia Pacific).
In the United States, regulation of vaccines is done by the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research. All sponsors of new vaccines in the US must undergo a “multi-step approval process.”
“Also included are information about the vaccine's safety and ability to elicit a protective immune response in animal testing, as well as the proposed clinical protocol for studies in humans,” the US FDA said.