Biomarker Validation Services: Major Trends And Challenges

The last 24 months have disrupted the entire timeline of the drug development process. The Covid-19 pandemic brought several problems that were never faced before. Scientists and drug developers had to confront and solve these challenges rapidly to get back the drug discovery timeline on track again. Today as clinical studies and life, in general, are back, pharmaceutical companies are faced with newer challenges while earlier trends now seem to grow.

The current growth in the pharmaceutical and biomedical industry is partially due to advances in biomarker analysis. A robust biomarker ensures that the developed drug is safe and effective in treating the patient population. Hence, biomarker validation services and biomarker analysis services have become experts in biomarker analysis to solve crucial aspects of drug discovery and development. The current article discusses principal trends and challenges faced in clinical trials from biomarker labs and clinical biomarker services perspectives.

Leading challenges in clinical trials

Today, the biggest single challenge clinical research faces is a lack of public trust. There is a growing disconnect between drug development industry and the public health sector. These trust issues are causing problems in trial recruitment and enhanced scrutiny of scientific research. Hence, it is the responsibility of the drug development industry to instill confidence in the general public which can only be achieved by being transparent and showing all possible benefits to the patient population.

Besides, the Covid-19 pandemic has changed the narrative of clinical research. Today, people are more conscious and question more about different aspects of drug development. However, the industry can take advantage of this opportunity to educate and engage with the patient population. Industry must discard higher-level scientific jargon and increase the understanding of clinical trials by explaining their importance. Let us now evaluate the prominent trends in clinical trials.

Major trends and challenges in clinical trials

According to GlobalData, the study anticipates that approximately 1300 decentralized and/or virtual trials will be initiated in 2022. Hybrid and decentralized trial designs are the most significant trend for 2022.  This number is 28% higher than 2021 and a staggering 93% from 2020. Covid-related disruptions such as healthcare interruptions and travel restrictions are the primary reasons for the popularity of hybrid and decentralized clinical trials. Besides, the major cause for decentralized clinical trials is their patient-centric approach. Decentralized clinical trials reduce the burden such as travel and thus qualify patients located far away from study sites.

Technology will also have a significant impact on clinical trials shortly. Numerous apps, platforms, and technological solutions are available for decentralized and hybrid clinical trials. GlobalData reports that web-based questionnaires and electronic informed consent were the two most widely employed innovative technologies in the past 2-3 years. Besides, the pandemic also saw that regulatory bodies widely accepted electronic patient-reported outcomes. Electronic patient-reported outcome aids patient fill and submit information about side effects, symptoms, and more through electronic devices. This acceptance was especially used in real-world data and real-world evidence studies.


Though the pandemic momentarily halted all drug development initiatives, the industry as a whole was able to maneuver these challenges effectively. Besides, current trends predict a bright future for the drug discovery and development industry.

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