07/27/2020 - 16:37
- Clarín.com
- Society
Pandemic Covid-19 highlighted the value of clinical drug research in Argentina, country and so far chosen to test a vaccine looming as promise against coronavirus . But what exactly do these clinical pharmacological studies consist of?
In the past few months, there have been hundreds of announcements about candidate COVID-19 vaccines, experimental uses of drugs approved for other diseases, animal sera, or plasma from cured patients. All of these may or may not offer a benefit, may cause mild or perhaps very severe side effects.
Clarín consulted two experts to find out what the processes are like, what standards must be respected, what methodological rigor they require and what times they entail.
"Demonstrating that a drug or vaccine is safe and effective takes time. It is estimated to take approximately 18 months to obtain a vaccine for Covid-19, and that seems like a long time, but it is a record speed compared to approximately 6-8 years that would take a similar development under normal circumstances, "explained Fernando Giannoni, director of external affairs for the Argentine Chamber of Medicinal Specialties (CAEME).
Participation in clinical research is voluntary and completely free . “The patient must give their consent through a process that includes sharing detailed information on everything related to the investigation. The volunteer can change their desire to participate at any time, without consequences, and should receive all new information obtained about the product under investigation through updates to the consent process, "said Paula Barreyro, director of Medical and Regulatory Affairs at Janssen Latin America South.
“Participants are protected by Ethics Committees, made up of medical professionals, scientists and community members, who ensure that all aspects necessary to protect the rights and safety of the participants are taken into account. In some cases, clinical studies are the last option for patients who have exhausted the available therapeutic options or, as in the case of Covid-19, there are still no treatments or vaccines, "added Dr. Barreyro.
Clinical studies are a 4-phase activity , which starts when a drug has already completed animal and in vitro tests and has shown that its efficacy, safety and quality can be evaluated in people.
The first stage, called 'Phase I', is performed on a small group of people and seeks to assess the safety profile , the adverse effects. The next stage, Phase II, is already in patients, in a small group, and tends to measure safety, but also efficacy and dose . Phase III is already in larger populations. Phase IV has to do with studies and monitoring of pharmacovigilance of products already approved and available in the market.
The case of vaccines is slightly different : the studies are increasingly in larger groups, but always in a healthy population (not in patients who are already infected with the virus or bacteria whose spread they want to prevent). What will be measured, in terms of efficacy, is the level of immunogenicity, which is its ability to generate antibodies against a given agent.
“The magnitude of the world crisis generated by the pandemic induced global cooperation never seen before in search of a solution. Experts worldwide joined together, as well as governments, private companies, research centers, universities and regulatory bodies. The investments not only include research, but also the conditioning of manufacturing plants in parallel with clinical research, with the capacity to produce millions of doses of the vaccine in advance, "said Barreyro.
The coronavirus, as it has changed many aspects of everyday life, may also modify some instances of clinical research from now on. Covid demonstrated that it is possible to speed up time , use technology on a larger scale to monitor investigations using all IT strategies, and advance remote procedures performed at the patient's home.
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