Clinical Trials in Times of COVID-19
Clinical trials are experimental evaluations of a product, substance, drug, diagnostic or therapeutic technique which, in its research and application to humans, aims to assess its efficacy and safety. Thus, these studies are an essential component of the scientific process, that promotes greater levels of accountability in research, improves transparency and public confidence in the conduct of clinical research, and gives visibility to all research, so that it can be considered in scientific literature reviews.
In a pandemic context, clinical trials face challenges to continue providing ethical and scientific solutions, likewise adapting to work during social distancing conditions and other factors caused by the virus. This environment has encouraged the pharmaceutical industry to adapt itself, to continue providing effective solutions.
Pharmaceutical companies are governed by a code of ethics and transparency, which extends throughout their production chain, ensuring the safety and efficacy of drugs, which is a research and development process of which the clinical trial is part. This process involves different steps, from the investigation of a component to the arrival of the medication in the hands of a patient; steps in the process include:
* Preclinical trial, not involving any humans.
* Clinical trials are divided into four phases to maximize the benefits and understand the risks of the new drug.
* Manufacture of the drug for delivery to patients.
* Approval and registration with the health authorities of each country to be marketed.
Thus, it is evident that clinical studies face new challenges, in a context in which in Latin America, 96% of organizations have had to implement work at home due to biosecurity conditions; despite this, the pharmaceutical industry has continued to propose safe and effective therapeutic solutions, adapting to work in the midst of social distancing, maintaining rigorousness from an ethical and scientific point of view, as described by Yaneth Giha, Executive President from the Association of Pharmaceutical Research and Development Laboratories (Afidro), in Desafíos y Oportunidades de la Investigación Clínica en Épocas de Coyuntura (Challenges and Opportunities in Clinical Research in Times of Momentum).
Along with the challenges faced by clinical trials, opportunities have arisen for some experts; for example, we still do not know how people are infected when the virus is in the environment, nor has the dynamics of transmission in the tropics or in high places has been understood, “this is an opportunity for clinical researchers, not an information gap,” commented the infectologist and National Coordinator appointed by the WHO for COVID-19 studies, Carlos Álvarez.
In this sense, it is possible to take advantage of this juncture to innovate, investigate and develop, because although more and more aspects of the virus are known, there is still much to be investigated and this is a window of opportunity that opens for the industry.
Strategies in Progress
Given that the pandemic led to the ending of thousands of clinical trials, researchers have employed strategies to conduct human studies remotely, reaching more people, quickly and economically.
The strategies implemented to deal with the eventualities of the virus have been accepted to general standards, such as those set out by the Pan American Health Organization (PAHO).
The above, bearing in mind that, although clinical trials during the pandemic may pose challenges, these should not compromise ethical and regulatory monitoring, which should be strengthened in view of the volume of virus-related studies being carried out.
In this regard, PAHO has recommended regulatory changes concerning the approval of the clinical trial, since their regulatory supervision must be conducted in the most expeditious manner during an emergency. This organization has also made suggestions for ongoing monitoring, considering that there may be changes in protocols because of quarantines, site closures, travel restrictions, alterations in the supply chain and in the event that site personnel or trial individuals get COVID-19.
In response to this, the National Institute of Drug and Food Surveillance (INVIMA) in Colombia, has provided a series of exceptional measures and actions applicable to the development of clinical studies during the emergency by COVID-19, providing guidelines for the remote monitoring of these studies, taking informed consent and other phases thereof; emphasizing the importance of having mechanisms to ensure that reviews of ethics committees associated with research centers are coordinated with the activities of the regulatory authority.
In the same sense , examples of changes in clinical trials that have been conducted during the pandemic, are those of the Cancer Research Center (CCR) of the National Cancer Institute (NCI) in the United States. These have been changes in procedures such as: Electronic signatures of patient consent forms, remote monitoring of clinical trial results, and sending oral medications to the home of patients participating in clinical trials.
On this, “we learned several lessons,” commented Dr. William Dahut, scientific director of clinical research at the CCR, who conducts clinical trials. “My hope is that we will leave this stage with improvements in the way we conduct clinical trials of cancer.” It has been shown that these types of changes provide flexibility for studies, without affecting patient safety or the validity of the data collected by the patient.
In addition, different scientists say that the pandemic has shown that there is room for innovation, and if these new practices persist, they could make clinical trials more economical, efficient and equitable, offering cutting-edge research opportunities to people who would otherwise not have the time or resources to make use of them.
Today, thanks to industry-wide adaptation to high standards, partnerships, and the momentum of pandemic research, clinical outcomes that were previously unlikely have been achieved. For example, it took 326 days to approve the first COVID-19 vaccine, and the world went from making 3,500 million doses of all vaccines annually, to having projections of about 10,000 million doses by 2021.
Also, researchers such as Dr. Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston, give a favorable part of the current clinical trial situation: “I am quite sure that if Covid had not occurred, we would have done things in the usual way,” he said. Sometimes, he added: “A crisis is needed to bring about change”.
It is also evident that the adaptation and reorganization of the industry in the face of clinical trials to face a context of crisis, continues providing humanity with a dose of hope; because if a clinical trial comes to a happy end, and it is concluded that the new molecule, for example, is a novel and useful alternative to treating a particular disease, then humanity will have gained a high dose of hope. This is how medical science advances and, therefore, the expectation and quality of life has increased exponentially over the past 100 years.