14 April 2022 | Views
Navitas Life Sciences brings to you 6 latest trends that pharmaceutical and biotechnology companies need to look out for this year
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The past couple of years saw a massive change in the way clinical trials were run and in the need for improved healthcare. Technology-led innovation has seen an exponential uptake, with McKinsey estimating that between $350 billion to $410 billion in Annual value can be created by utilizing such innovation to provide individual care. Clinical trial protocols have been quick to imbibe these innovations with oximeters, e-Consent forms, and tablets used for data collection. According to Global Data, a dramatic 93% increase in the uptake of decentralized clinical trials is expected in 2022, when compared with numbers in 2020. Apart from COVID-19 vaccines and therapeutics, 2022 will witness clinical trials that study the use of monoclonal antibodies, CRISPR-based gene therapy, and even oncolytic viruses for multiple conditions including cancer. Diabetes, cardiovascular disease as well respiratory diseases are among the conditions that are expected to be most studied in 2022.
The most critical factor that will drive the future of clinical trials is investments in state-of-the-art technology platforms, that bring to dominance decentralized trials and hybrid trials. Global Data has reported a likely 28% increase in decentralized clinical trials when compared to numbers in 2021, highlighting the significance of established yet agile partners in the ever-evolving clinical trial industry. The industry will see biopharma companies accelerating the consumption of diverse data sets to further define and segment patients as they address unmet patient needs. Biopharma companies and CROs will also advance capabilities to support cell and gene therapy trials and scale infrastructure and capabilities to support the same.
Decentralized Clinical Research, Direct-to-Patient Service
These are some of the important factors for direct-to-patient service • eConsent modules with disease area sensitivities in mind. • Clinical monitors working in conjunction with data management, ensures data integrity and regulatory compliance through remote monitoring, risk-based monitoring, and riskbased data management and quality management • Patient-centric eConsent, ePRO and patient-facing reporting to promote patient engagement and patient self-management, and modernize the patient experience.
The pandemic brought in a lot of changes including the need for dynamic clinical trial designs that allow greater flexibility, thereby engaging more patients and accelerating clinical trials. 2022 will also see a greater focus on pharmacogenomics and the use of patient data from wearable devices, paving the way for personalized healthcare.
Regulatory Affairs and Pharmacovigilance
2022 is set to be thrilling for regulatory and pharmacovigilance processes, with a focus on enhancing processes with technological innovations like AI, ML, and RPA. There will be an increased need to step up technologies with a risk of becoming obsolete otherwise. Service providers who are agile and swift in moving towards such advancements will forge better partnerships and drive growth for the next few years. The regulatory affairs outsourcing market from 2021-2026 is expected to grow by 4.63 Billion USD, reflecting exciting times for the BPO market. The conduct of clinical trials in Europe will also see a significant change with the Clinical Trials Regulation (Regulation (EU) No 536/2014) expected to come into effect from 31st January 2022. According to this regulation, a Clinical Trials Information System (CTIS) will now ensure supervision and assessment of clinical trials in Europe.
There will be a significant surge in the use of technology in clinical trials. Mobile technology and wearables for remote monitoring, 5 G and blockchain enabled virtual trial platforms for secure digital data collection and processing are just a few examples of high-impact solutions. These solutions would deliver superior outcomes in terms of feasibility, patient adherence/engagement, cost savings, and time to market.