Decentralized Clinical Trials. What does the future hold?
Over the last two years, the COVID-19 pandemic has caused a shift of dynamics towards decentralized clinical trials, rapidly accelerating the trend. Lockdowns, the redevelopment of medical facilities for COVID-19 treatment, and shortages of medical professionals, have complicated the manner in which traditional, fully centralized clinical trials are conducted. You could call the pandemic a tipping point in the industry, which forced many companies to take a decentralized approach to conducting clinical research.
So, what does the future have in store?
In order to understand what the clinical trials’ industry can expect in the future, let’s first take a look at the current trends.
According to a report done by Clinical Trials Arena in 2022, which used data analytics by GlobalData Plc, a “record number of around 1,300 trials with a decentralized and/or virtual component will likely be initiated in 2022” – up 28% from 2021.
Clinical researchers predict 3 times more remote interactions with patients in the coming years. Moreover, virtual interactions with Sponsors will increase 2-fold..
The use of telemedicine and digital data collection is rapidly increasing. GlobalData Plc identified 220 clinical trials using digital data collection in 2021, in comparison to an average of 20 per annum between 2010 – 2016. Additionally, eConsent also continues to grow significantly, driven by an increase in use among contract research organizations (CROs).
It is obvious that there is a rapid change in the way clinical trials are being conducted globally. So, what benefits will the implementation of decentralization bring to the clinical research industry, and particularly to the patients?
The first irrefutable incentive of clinical trials’ decentralization is the way in which it heightens the quality of patient care. Decentralization not only makes things more convenient and comfortable for the patients, but also improves quality of the data collected.
Also, with decentralization, it is now feasible to include previously under-represented ethnic minorities in studies, and obtain a more diverse data set. Diverse data sets can often bolster the validity of a trial.
Importantly, digital tools also make it easier to recruit and retain patients. They enhance the logistics of conducting research by simplifying the search, recruitment, and retention of subjects. Over the last few years, it has become clear that digital techniques decrease the costs of trials, since a significant proportion of the data can be collected automatically.
There are many clear advantages to a decentralized approach to clinical trials in terms of time/cost savings, and benefits for patients. It is therefore very likely that the uptake of these approaches will increase significantly in the coming years.
There are still some challenges to overcome with decentralization, such as regulatory issues, disparities in infrastructure across regions, and privacy and data protection concerns.
After COVID-19, the world has changed in many ways, and once foreign ideas have now become commonplace. Much like remote work and virtual meetings, decentralized clinical research is here to stay. The only question that stands is how fast the industry will adapt to this new trend, and progress into the future.
About Cromos Pharma
Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.
Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials.
We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.
Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.
