The Covid-19 pandemic is one of the most prominent modern-day medical challenges faced by humanity. Developing efficient drugs and vaccines is critical in overcoming the battle against Covid-19. Today the strategy employed by public officials is to flatten the curve, reduce mortality rates and accelerate the drug development process.
Due to limited knowledge and fewer ways to treat Covid-19 patients, the healthcare industry is under enormous pressure to find effective treatments and save the lives of infected patients. Novel effective and safe medical treatments are only possible through systematic and carefully designed clinical studies.
But during such an unprecedented time, successful novel treatments must be available as soon as possible. Biomarker assays for bioanalytics are one of the answers for the current unprecedented pandemic.
Urgent need for biomarker assay development and biomarker validation
A global collaborative approach called the Access to Covid-19 tools has been established for diagnostic and therapeutic development as well as a roadmap for future pandemics.
However, such a global approach will need the identification of Covid-19 biomarkers that will help in assessing the efficacy of future therapeutics and vaccines, preventing clinical complications, and allocating patient groups to relevant therapeutic interventions.
Data from GlobalData’s Biomarkers database suggest that several biomarkers are employed for Covid-19 clinical trials. These biomarkers are utilized for different purposes, such as predicting and monitoring safety and monitoring therapeutic responses. However, only a few of these biomarkers are validated and thus pose a risk of producing unreliable study results.
Routine coagulation tests and hematology laboratory findings have proved to be beneficial in predicting outcomes and recovery rates. Biomarkers can be crucial in deciding appropriate treatment strategies for Covid-19 patients. Inflammation biomarkers such as IL-6 and IL-10, and biomarkers of liver and kidney functions, and cardiac injury are significantly raised in Covid-19 patients. Such a cloud of biomarkers is termed as cytokine cloud. Biomarker labs are exploiting these distinct characteristics for cytokine testing of Covid-19 biomarkers. Biomarkers can help predict clinical outcomes and thus are crucial in the management of Covid-19 infections.
Integrated applications of biomarker testing in Covid-19 drug development
Covid-19 challenges are multifactorial. Apart from the limited understanding of the pathophysiology of the virus, time pressure, repurposing drugs, operational challenges, and regulatory approval are some of the fundamental challenges faced by the pharma and biomarker services.
In vitro and in vivo models are necessary for designing efficient clinical trials for Covid-19 drug development
. The knowledge of disease pathology, progression, and symptomatology, mechanism of immune response to the viral load, and host-virus-drug dynamics are the critical sets of information needed for designing a robust clinical trial program.
Biomarkers can play a crucial role in achieving all these sets of clinical data. Moreover, biomarkers can help implement all 4r standards of productive clinical trials i.e. right drug, right patient, right timing, and the right dosage.
The role ahead
Effective antiviral drugs and vaccines are urgently needed to combat the pandemic. Identification and development of effective therapeutics hugely rely on efficacious clinical trials in the drug development process. However, conducting clinical studies under pandemic conditions is a daunting task that can only be streamlined with the use of reliable and robust clinical biomarkers.