Clinical Research: Myths and Realities
By Ana María Flórez
There are countless myths that still exist today about clinical research for registration purposes, which unfortunately have a negative impact on the recruitment and enrollment of participants in the different trials.
For this reason, we want to dispel these beliefs by providing the reader with tools that will allow him/her to better understand the context of clinical research for registration purposes and its implications.
- Clinical trials are developed without any type of control. MYTH
It should not be ignored that historically, in remote times, for example during the Second World War, the experimental tests performed on human beings by Nazi doctors on their prisoners of war, evidenced multiple cases of violation. However, such facts, among many others, are considered the trigger for the fact that nowadays the field of clinical research for registration purposes is strictly regulated and controlled, basing its development on both ethical and legal principles that always aim at preserving the safety of the participating subjects.
Thus, when the field of clinical research was entered in Latin America and Colombia, fortunately, there already existed for a long time standards that strictly controlled the development of these trials, even with the passing of time these international standards have been adapted and converted into local regulation, giving way to new regulations such as the case of resolution 2378 of 2008 by which the Good Clinical Practices were adopted for the institutions that conduct research with drugs in human beings.
- Clinical trials are dangerous; participants are used as guinea pigs to test new drugs without knowing their effects. MYTH
While all research involves risks, in the case of clinical trials there should always be a ratio in which the risks do not outweigh the benefits. Before an investigational product can be administered to a participant, there have been numerous laboratory tests and controlled trials in animals and healthy research subjects to determine its safety profile.
In addition, it is necessary to emphasize that these trials must always be approved by a regulatory body, in our case, INVIMA, and by an ethics committee whose main objective is to watch over and safeguard the rights of the participants.
Therefore, at present, whoever decides to become a research subject, whether at a global or local level, can have full confidence that the trials for registration purposes have sufficient elements to guarantee their safety during their participation.
- Participants who are on placebo do not receive good treatment for their pathology. MYTH
One of the requirements demanded by the ethics committees for the approval of new trials is to ensure that the participants in these trials have the optimal treatment for the management of their pathology, thus guaranteeing that at no time will there be a worsening of their baseline condition due to the absence of treatment, even if they are on placebo, always ensuring that they are protected and controlled.
- It is mandatory to pay participants in a clinical trial. MYTH
In some countries it is allowed to provide monetary remuneration to participants in clinical trials, however, this practice is not endorsed by Colombian regulations. What is allowed includes: Transportation and food allowances, souvenirs or retention materials that are previously approved by the ethics committee.
Beyond the economic benefits that their participation may represent, it must be emphasized that the research subjects receive personalized attention and accompaniment at all times, especially directed to their pathology of interest.
- Participation in a clinical trial is mandatory until the trial is completed. MYTH
Undoubtedly, the ideal will be in all cases to complete the participation as proposed from the beginning in clinical trials, since this will provide more valuable information at the time of analyzing the results in the context of the research.
However, the decision to participate, as well as to withdraw from a clinical trial is totally free and voluntary, the participant at the beginning of the study will provide an informed consent in which he/she accepts to be part of the trial, however at any time and for any reason he/she may end his/her participation without any type of implication.
In Colombia and Latin America there are still many myths about clinical research for registration purposes, some of which have been refuted thanks to the hard work developed by the research actors since years ago and particularly during the period of the COVID-19 pandemic in which the importance of developing phase III studies evaluating the efficacy and safety of new drugs or treatments for emerging diseases was evidenced, thus providing collective benefits such as the reduction of morbidity and mortality cases of the population worldwide and particular benefits for the participants, among which are included:
- Follow-up and controls focused on your medical condition.
- Permanent accompaniment by a trained team of health professionals.
- Possibility of receiving new and effective treatments not available to the general public.
Finally, I extend an invitation to the readers to approach the research centers, inquire with the trained team and give themselves the opportunity to understand the functioning of these scenarios and, above all, allow themselves to improve their quality of life and contribute to the development of science and technology.