Clinical trials with vaccines
Clinical research in humans is currently highly regulated and rigorous from an ethical, logistical and scientific point of view. At all times, the well-being of the participating subject is above the need to achieve some innovative discovery in medicine, even in times of health emergencies.
In many countries, including Panama, there is a research law for drugs, vaccines and devices that, in addition to protecting the person recruited in the trials, supervises the quality and competence of the researchers and their study sites, legislating on the entire experimental process, and protects the legal security of the sponsoring entities (Law 84, May 14, 2009). No study can be carried out in the country without having been registered with the general health department and obtained the approval of the independent bioethics committees.
After the authorization of the project, the participant must go through a meticulous informed consent process that includes knowing extensive information about the potential benefits and risks, data from previous product investigations (in vitro, animal model, previous clinical phase) and the rights or duties in case of accepting your enrollment. The decision is completely voluntary, autonomous, free and devoid of any economic incentive.
The subject can discuss consent with family, friends or professionals before signing. Once inside, the individual must comply with the follow-up visits and with the procedures described in the protocol (vaccinations, sample extractions, records of adverse events, calls or alert messages, etc.). In case of dissatisfaction or inability to adjust to the demands, the person may also choose to withdraw without this causing any kind of affectation.
The proper conduct of a research study is constantly monitored by companies specialized in data monitoring, audited by organizations in charge of quality processes and inspected by regulatory bodies (FDA, EMA, ethics committees), according to the relevance and magnitude of each project. Participants who, by chance, are in the control group, are assigned a comparator vaccine as a benefit, apart from being entitled to medical evaluations and laboratory tests that ensure optimal surveillance of their health condition.
Considerable evidence reveals that people who join clinical trials, even receiving placebo, have advantages over those who do not participate, because they receive frequent personalized attention by a professional team trained and certified in good clinical practice.
At the end of the investigation, if the evaluated product is safe and effective, it is offered free of charge to those who, by random destination, did not have it at the beginning.
Being able to participate in a scientific study is considered a basic human right. Everyone should have that option and in their own country of residence. Any of us, faced with a potentially serious illness, would travel to a place where some new and promising treatment is experienced to improve the prognosis.
Not everyone, unfortunately, has the resources to move to those research sites. Therefore, the bringing of projects to our region should be encouraged. In addition, not all therapy or vaccine behaves the same in Caucasian or Asian populations as in black, mestizo or indigenous populations.
Although the literature indicates that the majority of people who decide to join clinical trials do so for altruistic reasons (to improve the health of others and advance medical knowledge), others hope for a direct benefit or the opportunity to contact professionals trained to discuss health problems for themselves or for their family members.
No academic institution or pharmaceutical corporation risks studying its vaccine in a country that does not provide quality research, ethical rigor and publication in high-impact journals. For the studies on Covid-19, national vaccine researchers have joined in a country project, a consortium or coalition with more than 20 years of experience and trajectory in studies of national and international relevance, both in children and in adults.
Several important projects in the prevention of SARS-CoV-2 infections will soon begin, which will surely provide scientific information on the safety and efficacy of various vaccines, with diverse technological platforms. The advantages of evaluating numerous vaccines worldwide are multiple: greater accessibility, less commercial monopoly, better price and differential value for specific age and risk groups.
Vaccines are, after drinking water, the most cost-effective investment that exists in public health, not only in preventive impact and risk-benefit ratio, but also in the fight against social inequality.
Young people should review history so that they can know the figures of millions of people who died, were paralyzed or suffered serious physical consequences from multiple communicable diseases (polio, measles, rubella, tetanus, diphtheria, tuberculosis, meningitis, pneumonia, whooping cough, diarrhea, hepatitis, chickenpox, etc.) that today have been controlled or eradicated thanks to vaccination. For the few who would like to live without vaccines, this pandemic is the best example of the absence of one; now imagine the world without any.
The author, Xavier Sáez Llorens, is a doctor
After the authorization of the project, the participant must go through a meticulous informed consent process that includes knowing extensive information about the potential benefits and risks, data from previous product investigations (in vitro, animal model, previous clinical phase) and the rights or duties in case of accepting your enrollment. The decision is completely voluntary, autonomous, free and devoid of any economic incentive.
The subject can discuss consent with family, friends or professionals before signing. Once inside, the individual must comply with the follow-up visits and with the procedures described in the protocol (vaccinations, sample extractions, records of adverse events, calls or alert messages, etc.). In case of dissatisfaction or inability to adjust to the demands, the person may also choose to withdraw without this causing any kind of affectation.
The proper conduct of a research study is constantly monitored by companies specialized in data monitoring, audited by organizations in charge of quality processes and inspected by regulatory bodies (FDA, EMA, ethics committees), according to the relevance and magnitude of each project. Participants who, by chance, are in the control group, are assigned a comparator vaccine as a benefit, apart from being entitled to medical evaluations and laboratory tests that ensure optimal surveillance of their health condition.
Considerable evidence reveals that people who join clinical trials, even receiving placebo, have advantages over those who do not participate, because they receive frequent personalized attention by a professional team trained and certified in good clinical practice.
At the end of the investigation, if the evaluated product is safe and effective, it is offered free of charge to those who, by random destination, did not have it at the beginning.
Being able to participate in a scientific study is considered a basic human right. Everyone should have that option and in their own country of residence. Any of us, faced with a potentially serious illness, would travel to a place where some new and promising treatment is experienced to improve the prognosis.
Not everyone, unfortunately, has the resources to move to those research sites. Therefore, the bringing of projects to our region should be encouraged. In addition, not all therapy or vaccine behaves the same in Caucasian or Asian populations as in black, mestizo or indigenous populations.
Although the literature indicates that the majority of people who decide to join clinical trials do so for altruistic reasons (to improve the health of others and advance medical knowledge), others hope for a direct benefit or the opportunity to contact professionals trained to discuss health problems for themselves or for their family members.
No academic institution or pharmaceutical corporation risks studying its vaccine in a country that does not provide quality research, ethical rigor and publication in high-impact journals. For the studies on Covid-19, national vaccine researchers have joined in a country project, a consortium or coalition with more than 20 years of experience and trajectory in studies of national and international relevance, both in children and in adults.
Several important projects in the prevention of SARS-CoV-2 infections will soon begin, which will surely provide scientific information on the safety and efficacy of various vaccines, with diverse technological platforms. The advantages of evaluating numerous vaccines worldwide are multiple: greater accessibility, less commercial monopoly, better price and differential value for specific age and risk groups.
Vaccines are, after drinking water, the most cost-effective investment that exists in public health, not only in preventive impact and risk-benefit ratio, but also in the fight against social inequality.
Young people should review history so that they can know the figures of millions of people who died, were paralyzed or suffered serious physical consequences from multiple communicable diseases (polio, measles, rubella, tetanus, diphtheria, tuberculosis, meningitis, pneumonia, whooping cough, diarrhea, hepatitis, chickenpox, etc.) that today have been controlled or eradicated thanks to vaccination. For the few who would like to live without vaccines, this pandemic is the best example of the absence of one; now imagine the world without any.
The author, Xavier Sáez Llorens, is a doctor
