Clinical trials are moving more and more towards being fully digitized, with more digital health products being utilized to enhance data collection and remotely monitor patients, regardless of location. Considering that 58% of clinical trials were disrupted by the pandemic last summer, a greater need exists for the technological enhancement of all aspects of the clinical trial process.
Additionally, there is increased demand for personalized medicine to aid patient convenience and help physicians directly address patient needs. And, there is a wide range of macroeconomic trends like the increase of deal activity and job availability. The objective of every clinical trial going forward should be to minimize costs while creating the most engaging patient experience possible. These are some of the notable clinical trial trends you need to pay attention to throughout 2022.
Addressing Trust Issues
Trust is a crucial aspect of conducting clinical trials.
The biggest challenge in the clinical trial industry for 2022 is gaining the trust of patients and doctors alike. Disconnects between the drug development industry and the public health sector have led to declining patient recruitment and increased scrutiny surrounding clinical research.
It’s clear that the traditional approaches to clinical trials are outdated and, with the widespread effects of the pandemic to be felt for the foreseeable future, the clinical trial industry. Not only should there be an increased focus on digitization, but more transparency is needed to ensure the clinical trial process achieves the kind of data optimization and exchange it craves.
Regaining trust requires the breaking down of silos and showing all of the processes that benefit patients. The drug development industry aims to step up in more proactive ways to gain public trust, responding to increased empowerment from the public as they question things more. Because of this increased empowerment, expect to see more engagement between the public and clinical trial experts, with clearer explanations about how trials work, including decentralized trials. Clinical trial experts must lead these high-level, educational conversations and capitalize on potential teaching moments to encourage increased participation from the public.
Increased Decentralized Designs
COVID-19 has sped up the creation and adoption of decentralized clinical trial designs. Thousands of clinical trials have experienced delays since the beginning of the pandemic, with around two-thirds of healthcare experts expected to adopt a decentralized model due to shifts triggered by the pandemic.
Approximately 1,300 decentralized or virtual trials are expected to begin in 2022, a 28% increase from 2021. A big part of the reason for the increased popularity and adoption of decentralized trials is that they afforded clinical trial experts more time and opportunities to conduct research amid lockdowns, healthcare interruptions, and travel complexities triggered by the global pandemic.
Decentralized trials facilitate more patient-centric approaches, reducing travel/location-based burdens, encouraging people in faraway places to readily participate in trials. Decentralized research will increase in 2022 and beyond because they serve various groups, including low-income communities, and allow people based hours away from the trial site to participate in trials, reducing research costs and providing greater convenience for patients. The biggest hindrance for clinical trials has long been participation, as many indicate their desire to involve themselves in trials, but few follow through because of location restrictions or health issues that prevent them from participating, even if they are near the trial site.
Opening up patient pools and reducing the necessity for traveling for trials will increase participation in minority and low-income populations, gradually eradicating attrition rates. Additionally, the increased presence of decentralized trials offers significantly reduced costs, including up to 50% for telehealth compared to on-site visits. Study administration costs will also be reduced with the increased digitalization of trials while recruitment and retention improve, eliminating delays and preventing unnecessary expenses.
More Inclusivity and Better Representation in Clinical Trials
As mentioned above, expanding patient pools boost participation from minorities and people in low-income households, with more unconventional trial designs being created in recent years to increase clinical trial operational efficiencies. There will be more opportunities for various platform trials to achieve stronger momentum in gene therapies, while decentralized trials also address rare diseases that often plague less-advantaged communities.
The pandemic has facilitated a more pressing need for increased representation in clinical trials, with the industry as a whole promoting greater inclusion, demanding more robustness, including a greater range of applications. Decentralized trials have no demographic restrictions, providing more opportunities to diversify clinical trial representation.
Infrastructure Changes for Clinical Trial Sites
Disruptions caused by the global pandemic have forced a rethink on healthcare research operation in the last two years, with more alternative models manifesting to utilize digital technologies and more seamless setups to encourage greater site participation.
Staffing issues are rife within traditional research entities and dedicated sites, with a lack of staffing solutions to meet all trial needs, as well as new sponsor protocols. Clinical trial management technology, automatic data captures, and eRegulatory systems are among some of the digitized solutions that have been recommended. However, all have failed to actuate substantial improvements regarding labor reduction. Simply adding more research coordinators to capture more sponsored clinical trial opportunities isn’t enough.
Newer clinical site models promising improvements in data efficiency and quality, plus providing more enrollment opportunities, will be more prevalent in 2022. Focused site networks and the expansion of nontraditional entity-led clinical trial research will become the norm for the foreseeable future.
Additionally, more support will be provided for clinical trial sites, with more modernized approaches to creating networks that support research as a potential care option in different use cases, like in oncology, for example. High turnover, protocol complexities, and disparate technology use will continue to be prominent. But, with the demand for digitization arguable being higher than ever, these new approaches will become attractive, allowing sponsors to reach more patient populations and sites being more efficient.
Decentralized clinical trials represent new opportunities to physicians and patients alike, ensuring a less extensive and more valuable clinical trial process. At Adaptive Partners, we team up with community physicians to integrate clinical trials into their practices to provide new opportunities for the patients they recruit. Learn how we do this through our various solutions.
