Bioethical Cases within Clinical Trials During COVID-19; Vision towards a New Design Focused on the Patient ́S Safety and Needs

The world is currently undergoing a pandemic that has forced
everyone to familiarize themselves with the term COVID-19,
an infectious disease caused by the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2)...


Introduction
The world is currently undergoing a pandemic that has forced everyone to familiarize themselves with the term COVID-19, an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1,2]. This pandemic has led to significant loss worldwide starting December 2019, reaching Mexico on February 2020 and still going strong [3] is a vulnerable country in this regard, considering its population has a very high prevalence of cardiometabolic illness, a mayor risk factor for a bad prognosis regarding COVID-19. This has to do with the effect that these illnesses have on the immune system and the chronic inflammatory state they sponsor [4,5]. The pandemic caused by COVID-19 has brought out hard questions regarding ethics that warrant careful consideration for solid decision making that protects the rights and health of our patients [6,7].
Research centers in Mexico as in general are responsible for the health of their subjects and patients which is why it is so crucial that they uphold sanitary and institutional directives and guidelines to minimize risk during studies and treatments. New ways to carry on with these experimental studies have had to be developed.
Some have implemented home delivery systems for medicines and equipment to prevent unnecessary exposure by going to a center or clinic. However, research product storage and handling is delicate and must follow adequate procedure and documentation. Through it all, patient/subject health must remain the priority of all health personnel. Preventive medicine is another subject that has gained importance throughout these hard times, recognizing that healthy habits on a daily basis decrease the chances of a poor prognosis after contracting SARS-CoV-2.
Preventive medicine also entails doing all that we can to avoid spreading this very infectious disease through protection gear and precise screening for all health-related personnel. This profession has been tested specially during these times of uncertainty and urgency combined, knowing that there are no definitive answers regarding treatments or cures, still doctors are expected to know how to proceed and must make decisions that will impact lives while protecting patient rights, legal and bioethical aspects [8].
Perhaps the most dangerous characteristic of SARS-CoV-2 is its novelty and the lack of knowledge it comes with. Research centers across the globe are speeding towards finding treatment options as well as vaccines, but there are no real shortcuts for this, and good clinical practices must be observed throughout [6].

Case Report
Male patient that enters a phase 3 pharmacological study with moderate rheumatoid arthritis. At baseline presenting oral temperature of 36.2oC, respiratory rate of 18 rpm, and body weight of 70.4kg. Across the study, a 20% improvement in joint counts was Generally, every physician has a different approach on this, since this does not just apply to the current pandemic, medical research is constantly updated and doctors in every specialty must self-educate to stay current and relevant.

Conclusion
Bioethics enforce necessary regulations that help guarantee patient/subject safety, which makes this a priority issue. We are undergoing an unfamiliar situation worldwide, a devastating pandemic that has gone on for over a year now, however, this situation is not the only current health threat affecting many people.
A great deal of other chronic illnesses and infectious diseases are not holding back, which is why research must go on. Preventive measures are of the essence to lower vulnerability in the general population. One of the lessons this pandemic has left us with is the importance of taking care of our patients and making sure they take care of themselves as well because any disease will have a stronger toll on those left vulnerable by previous illness specially if it goes untreated. The important thing to remember is that the ultimate goal is patient well-being. Respect for life and its quality should guide health personnel´s decisions to avoid wrongdoing.