Research article by: Dr. Jorge Estrella MD, President & CMO at ESTERN Medical CRO Life Sciences
The challenges from the impact of COVID-19 in the Clinical Research has pivot into decentralized (virtual) Clinical Research trials.
Although many industries have been negatively impacted by COVID-19, the Clinical Research and health product Life Science market has experienced an upswing in recent months in some targeted areas such as infectious diseases (vaccines), diagnostic imaging MRI / CT, cardiology and pulmonary treatments for Covid-19 and other R&D treatment indications.
As demand for these key specific clinical indication’s products skyrocketed, clinical research is increasingly needed to get approvals from international regulatory agencies such as the US-FDA or EU-EMA, to potentially approved and commercialize those products while supporting safety & efficacy of the pharmaceutical & medical device R&D.
However, the present mandates of global lockdown and safety measures necessitated by COVID-19 have ushered in new R&D challenges for Pharmaceutical, Biotech’s & Medical Device sponsors with current pipeline studies underway or those planning for upcoming clinical trials to be either pause or slower pace process its main target timeline project indication that we ESTERN Medical, as company, provide our clinical overall support into those Life Science international companies across the US North America & Latin America / South America regions.
The barriers and challenges in executing clinical research in the age of COVID-19 constraints that have traditionally impacted regulatory trial timelines and execution that have been exacerbated by the global Covid-19 pandemic landscape.
The patient participant recruitment is still a complex top challenge given regional and global differences in COVID-19 in positive cases. There is also uncertainty about “by country hot spots” and potential third and fourth waves in some countries, as well as concerns about prioritizing patient safety, meeting enrolment targets, and minimizing drop-out rates.
Any given hospital or the clinician’s safety and providing proper personal protective equipment (PPE) has become a priority amidst medical supply shortages in some countries. Many complex considerations come into play for both participant and staff safety. At minimum, the average study visit duration is likely to increase due to additional safety measures due to COVID-19 precautions (example: temperature checks, contact tracing measures, PPE requirements, etc. etc.) that are still in place globally.
Site closures and reduced capacities have also forced our company’s Pharmaceutical, Biotech’s & Medical Device sponsors to re-select hospital sites, extending study timelines and, in some cases, increasing budget. The fact that COVID-19 vaccine and therapeutic trials are ongoing further compounds the issue, affecting site network capacities globally and with the proper clinical & scientific expertise.
It is very clear that clinical research development must continue, but many of our company’s sponsor Pharma, Biotech’s & Medical Device companies are unsure how to successfully execute their trials indications without compromising the quality or integrity of the overall research while trying to avoid unwanted budget increases and longer potential timelines.
Contact us to discuss your R&D clinical trial study in the US or Latin America.