While clinical trials are essential to get drugs to the market, there is a severe investment risk involved for companies, given that less than 12% of drugs make it to commercialization (DiMasi et al., 2016). In addition, patient recruitment is seen as a major cost driver in the execution of clinical trials.
While reducing can be difficult, one way of reducing financial burden is by clinical trial decentralization. In 2022, the global market for virtual clinical trials reached $8B (Armstrong, 2022), with mounting evidence suggesting that decentralized clinical trials (DCTs) can yield significant financial benefits for study sponsors. A study by the Tufts Center for the Study of Drug Development found that DCTs can provide a significant return of up to 5 and 13 times the investment for phase 2 and phase 3 studies, respectively (DiMasi et al., 2023).
Centralized clinical trials can place significant physical and emotional burdens on patients, and may also lead to biased results due to underrepresented patient populations, underscoring the importance of addressing these limitations to promote more inclusive and representative clinical research.
Phase I clinical studies with healthy volunteers, in particular, are loaded with clinical visits for blood draws and other clinical assessments. Doing this in a centralized care setting is very labor-intensive. The demanding nature of centralized clinical trials can lead to participant dropout rates as high as 40%, highlighting the significant challenge of maintaining participant engagement and involvement in the study (Ali et al., 2020).
This is where DCTs, trials that take part in a local point of care or someone’s home, come into play.
In this article, we will explore the current and future state of DCTs and their potential to transform the drug development process. Since 2020, stakeholders have observed a 50% increase in DCTs (Parkins & Hillman, 2021), which use remote monitoring and data collection to reduce patient burden and improve study efficiency (Figure 1).
Figure 1: The impact of Covid-19 on trial decentralization (PreScouter – data source: primary research, based on 5 expert interviews from companies working in the DCT space).
“As we project into the future, we expect a significant increase of approximately 65% in DCT adoption by 2028. This optimistic projection is primarily attributed to the progressive realization of innovative processes and services leading to more decentralized interactions across the globe.” – Expert in Decentralized Clinical Trials from a Leading Sponsor in the Pharmaceutical Space.
While the Covid-19 pandemic has accelerated the adoption of DCTs (Goodson et al., 2022) as sponsors faced patient recruitment and trial conduction challenges, the DCT model also comes with its own issues. When assessing the feasibility of different DCT models, sponsors must consider operational challenges, such as:
- Regulatory approvals or challenges within suppliers’ capacity to perform with versatility.
- Patient challenges may also arise, including consent or privacy.
- Reliable sample collection and data management.
Variations in DCT implementation are flexible, with some sponsors opting for partial decentralization and others going fully decentralized (Figure 2). Despite the challenges, the adoption of DCT is rapidly becoming a crucial business strategy for pharmaceutical sponsors, revolutionizing the industry’s understanding of clinical research. Such increasing interest in DCTs offers a promising opportunity for pharmaceutical sponsors to partner with CROs and embrace modern technologies, driving patient-centric and efficient trials that revolutionize the industry’s approach to clinical research.
Figure 2: Clinical trial specificities according to the selected approach (PreScouter – data source: primary research, based on 5 expert interviews from companies working in the DCT space).
Overcoming challenges: How pharma companies can strategize decentralized trials
While DCTs offer many advantages, they also present several challenges that must be addressed to ensure their success.
Challenge #1: Regulatory Compliance
- DCTs involve complex legal and regulatory considerations, including new and innovative technologies that may not have clear guidelines or regulations (de Jong et al., 2022).
- Trials require crucial submission requirements and timelines from regulatory agencies, including shipping supplies to sites and storing samples long-term.
- Ensuring compliance with local, state, and federal regulations requires close collaboration between sponsors, investigators, and regulatory bodies.
- Sponsors can implement a robust regulatory strategy that includes ongoing monitoring of regulatory data to ensure the highest level of regulatory compliance.
Challenge #2: Safeguarding the Quality of Data
- DCTs depend on remote monitoring and self-reporting, which lack the constant presence of medical professionals (Thomas & Kidziński, 2022).
- Innovative solutions for data and sample collection, such as wearable technologies and digital health platforms, can enhance the reliability and precision of data collected.
- This includes cutting-edge wearable technologies, remote monitoring devices, and digital health platforms that enable real-time, objective data collection in a non-invasive way for trial participants.
- Comprehensive data management systems, including automated data cleaning and quality control checks, can further enhance the accuracy and reliability of the collected data.
Challenge #3: Supply Chain & Logistics
- Further consideration needs to be given to the collection, management, and storage of biological samples (Maass et al., 2022).
- Efficient logistics and operations management are crucial for the success of DCTs, especially in remote or underserved regions.
- Developing a comprehensive logistics plan, including landscape research to pinpoint proficient CRSs and CROs, is necessary.
- Staying abreast of the latest research and breakthroughs in remote sample collection can help sponsors simplify the process, ultimately leading to a smoother DCT implementation.
Strategies and recommendations for success in decentralized clinical trials:
As the healthcare industry continues to evolve and adapt to new technologies, DCTs are becoming an increasingly crucial business strategy for pharmaceutical sponsors. As DCT gains momentum, its continued growth is expected to be a key driver in the development of more efficient and effective clinical trials, offering new opportunities for innovation and growth in the healthcare industry.
Ensuring regulatory compliance, maintaining data quality, and managing logistics and operations are just a few of the hurdles that sponsors must overcome to successfully implement DCTs (Figure 3). By tackling the three main DCT challenges head-on, businesses can position themselves for long-term success in future drug development.
Figure 3: Recommended steps to tackle trial decentralization challenges (PreScouter – data source: primary research, based on 5 expert interviews from companies working in the DCT space).
Are you interested in learning more about DCT? Contact me at ‘mkreusch@prescouter.com’ to learn how I help my clients save up to 13 times the investment for late-stage clinical trial conduction.
