Read our updated trends report here: 2023 Clinical Trial Trends
Clinical trials are a necessary, but frequently costly and burdensome, part of providing innovative treatments and improving health outcomes globally. In fact, conducting a clinical trial has been one of the greatest costs in bringing a new drug to market as part of the drug development process. Breakthroughs in science and changes in regulatory policies have enabled advancements that have increased the quality, speed, and design of clinical trials. Simultaneously, new and existing technologies are being employed to aid in matters ranging from patient health data collection to enrolling in a remote trial.
2022 Clinical Trial Trends
Here are five clinical trial trends the industry should be watching in 2022:
Trend #1: Clinical trials are increasingly being conducted in a decentralized model.
The COVID-19 pandemic caused the development of a plethora of novel technologies within the life sciences industry that enable researchers to work effectively and remotely. An imperative emerged that shifted the traditional hub-based research trial model, where participants gather for an on-site trial experience, to a new experience involving remote monitoring and telehealth with clinicians. Simultaneously, the onset of the pandemic in the spring of 2020 caused many ongoing trials to be placed on hold, or canceled altogether, as the original trial design proved impossible to conduct without the risk of contagion.
A decentralized trial can incorporate technology at different steps of the clinical development process as well as help to remove barriers that have historically led to a lack of diversity in trial participation. Web-based document signing removes a burden on trial participants by allowing the documentation, registration, and informed consent process to be done from a patient’s home. Likewise, the widespread adoption of electronic health records among clinicians and researchers facilitates access to patient health records across sites and remote work settings.
The challenge to conducting decentralized trials is finding a balance between remote and on-site elements in the trial design. Ongoing decentralized trials may require a combination of in-person and remote activities, ranging from participation through a local health care practitioner to telehealth technologies delivering clinical contact at home.
The degree to which a trial can be decentralized is dependent on the factors of the clinical investigation. Trials that involve more serious illnesses, extensive procedures, advanced imaging, biopsies, and interventions with significant risk will still require close monitoring by clinicians and researchers. Trials involving more serious clinical attention may need to determine what elements of a decentralized design is best for the research and at what stages to implement such elements.
Trend #2: Digital tools are enabling clinical development processes and outcomes.
Digital tools and software are evolving and enabling clinical development. There is a growing trend of employing software and other digital tools to manage trial complexities, similar to the way ERP systems coordinate a business’s operations. Continue reading by downloading the full report below, and learn more about our Life Sciences Consulting Services here.
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Contributions by Dawid Gil