Look for new trial designs and changing CRA skills in 2022 says Syneos
Patient-powered study designs and changing roles for CRAs will shape the clinical trials sector in 2022 according to Syneos Health.
The contract research organization (CRO) made the prediction in a recent report, suggesting the coronavirus pandemic prompted a wave of innovation in all part of the biopharmaceutical development ecosystem.
Leigh Householder, managing director, Omnichannel Strategy, said “The pandemic forced fast-moving innovation, prompting biopharma organizations around the world to validate real-time insights and learnings that are now fueling industry change and value creation.”
The key phrase will be “appropriate acceleration” according to Syneos, which suggested drug developers and contractors would embrace innovative study designs – including decentralized studies – and real-world data to try and speed up trial.
The CRO also said participants will play more of a role in shaping studies, predicting studies in 2022 would be “informed by the patient voice and focused on recruitment that reflects the burden of disease.”
Diversity
Ongoing efforts to make clinical trials more representative will continue this year according to Syneos, which said the focus will be on outreach.
The authors wrote “Advancing Diversity, Equity, and Inclusion (DE&I), both inside our own organizations and among stakeholder populations including investigators, study participants and patients, will be a critical strategic priority for the industry in 2022.
They also predicted the drug and CRO industries will make “targeted investments” and embrace “new measurement models” to try to increase diversity in clinical trials.
Clinical staff
Syneos also said trial staffing is also likely to change over the next few years as the sector tries to build the skills needed for emerging therapies and ensure operations are able to withstand potential disruption.
The report authors wrote “We’re watching new roles grow while long-trusted roles change; new channels open and others open even wider. Look for a newly hybrid field, changing roles for clinical research associates (CRAs) and new paths to recruitment.”
Specifically they suggested that rather than focusing on source data verification, over the next three years CRAs will play an increased role in risk based monitoring during clinical trials.
The authors predicted that “While CRAs may still perform site visits, the frequency of those visits is expected to continue decreasing, allowing them to work in more flexible environments and at the top of the skillsets.
“The CRA of 2022 or 2023 might expect to work more like a data analyst, evaluating enrolment against protocol, reviewing drug accountability and verifying adverse events. They will increasingly be focused on critical study risks and overall site performance.”
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