Why does it take so long to get new treatments and vaccines to market?
This topic has been discussed for years now within the clinical research industry with not yet fully established approach on shortening clinical trial timelines, improving recruitment and retention of patients and aligning the research study with what patients want to find in a therapy.
Although there has been tremendous progress in the way clinical trials are being conducted, the same numbers keep on reminding us something is wrong:
- 85% of clinical trials fail to recruit and retain enough patients in order to meet their enrollment timeline;
- 80% of trials fail to finish on time, no matter that one-third of a study budget often goes into patient recruitment and retention;
- 19% of registered clinical trials are terminated due to failure to reach expected enrollment.
No matter how much scientifically advanced medication a company is developing, at the end of the day, clinical trials are a “postcode lottery” for those that need the treatment the most. Being lucky to live in the same town or city and even close to a research centre conducting a study is something that a limited number of people experience.
Fortunately, discussions about how to move to decentralized clinical trials (DCTs) or design hybrid protocols are occurring on an ongoing basis as organisations seek to develop new strategies that will create competitive advantages and will allow for delivery and scaling of new treatments to patients that are interspersed geographically.
In this article, we are outlining some of the major benefits and barriers of decentralized clinical trials and will be further deep-diving in all the aspects to be considered by the industry.
- Enhanced patient experience
DCTs offer a more patient-centric approach by allowing patients to participate in clinical trials from their home, spend more time with their family, focus on work responsibilities and not dedicate their daily lives to the thought of being sick while being stuck in hospitals.
Moreover, this model is especially helpful for patients with mobility issues or those who do not reside near a clinical trial site.
- Less burden for travel
According to a biennial global research study conducted by CISCRP that included 12,450 respondents, travel time to clinics was reported as a major burden impacting participation, especially among young people. “Geography and the distance to the clinical site” was the main barrier for trial participation for 60% of patients.
The decentralized model would allow for an increased convenience of participation. Patients all across countries would be able to access treatments regardless of their place of residence and not be burdened with the financial costs of participating in a study, e.g. travel/parking costs.
- Less disruption of daily life
No matter that participation provides them with new hope and access to a promising new therapy, it takes a lot from their personal life. In order to complete all hospital visits, patients are required to skip work for several hours or days multiple times throughout the duration of the study; leave home and childcare or even rely on a family member who needs to accompany them or drive them.
In a recent video, Trishna Bharadia, an MS patient and patient advocate, shares her daily living experience managing multiple sclerosis and discusses the evolution toward decentralized clinical trials and the impact that would have on a patient like Trishna’s ability and willingness to participate in a clinical study.
Living a really busy life working in a business intelligence company, she needs to manage her MS and other chronic conditions she lives with.
“There is no point in taking part in something which is potentially going to make you feel exhausted or is going to have a burden on your finances.”
The value of decentralized clinical trials is the use of technology to make the patient’s life easier where people can stay home while being screened, monitored or even treated.
- Improved patient recruitment and retention
Relieving the burden for patients to take part in research has proven to increase patient recruitment rates which is currently one of the biggest challenges of the life science industry.
However, the successful conduct of clinical trials doesn’t only mean finding and getting patients to take part in the trial but also keeping them engaged and motivated to continue their participation. Within patients who consent, an alarming 30% dropout rate across all clinical trials is observed. Therefore, improving the patients’ experience through protocol optimisation to ease the perceived patient burden should increase the probability of success. By requiring fewer or no site visits, DCTs decrease the burden for both patients and caregivers, contributing to higher patient retention.
- Data accuracy
Gaining access to a larger population via a larger geographical footprint, DCTs allow for capturing the big picture and how the new treatment might affect diverse patient groups.
By deploying mobile technologies, DCTs can collect a greater quantity of data from patients over time than what can be collected in traditional site-based clinical studies. Thus, they provide data which is closer to a real-world setting compared to the data collection during site visits which is limited by visit frequency and length.
One of the biggest problems of the traditional model of conducting clinical trials is that data is scattered across multiple proprietary systems that are often independent and incompatible with each other.
This category is one of the largest expenditures associated with remote trials. DCTs require an investment in technology platforms (e-consents, e-PROs, wearables, apps, telehealth, etc.) that harmonize all the various digital efforts in trial conduct for analysis, monitoring, cleaning, submission. The return on investment (ROI) will not be seen right away, however, over time and with the scaling of multiple products and studies, the foundation of established and integrated software platforms will be reflected on the quality and quantity of data.
- Validated virtual technologies
As the industry moves to greater adoption of digital technologies and remote visits in clinical trials, it can be difficult in the early stages to be confident in choosing providers that will not only provide the best technology/service but also protect the patient’s privacy while providing data in the right format at the right time.
The industry will need to establish and optimize processes for vendor selection and monitoring that needs to go beyond the traditional collaboration models and ensure that the smart application of technological solutions are in place to overcome barriers to trial execution.
- Need for patient-physician interaction
According to a biennial global research study conducted by CISCRP that included 12,450 respondents, a patient’s relationship with their doctor was found to have the greatest impact on willingness to participate.
People – and not just patients managing a health condition – want to be seen by a doctor. They are more comfortable being seen in person by a physician, particularly when they are participating in a clinical trial for the first time and may not be familiar with the ins and outs of participation.
The human connection is still the number one part of the experience for a patient in a clinical trial. A part of the experience might be lost in siteless trials and the perceived convenience for patients of a siteless trial would not entirely offset the desire for human to human interaction.
The new technological tools could also create a burden for technology-averse patients or those not possessing the latest tablet or smartphone.
- Concerns for data privacy
Adhering to patient data privacy is extremely important when sponsors, sites and patients increasingly rely on remote communications. DCT operators must maintain compliance with data privacy and security regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] and General Data Protection Regulation [GDPR]). As these are continuously evolving those operating DCTs must ensure they maintain up-to-date knowledge.
Users and site administrators of applications and softwares should adhere to best practices for password security. Software and hardware should have the latest security patches, and anti-malware software should be deployed.
Harnessing new technologies, such as blockchain, can improve the privacy of sharing data across large networks of users and can keep track of data transactions through a tamper-proof chain of custody of all medical devices.
- Regulatory acceptance of virtual data collection
It’s often said that one of the reasons for slow technology adoption in the pharma industry is regulatory concerns. In many cases reported by the industry, for large Phase 3 trials regulators are not ready to accept digital endpoints.
Still, we’ve been observing huge progress in this regard as of last year when the Food & Drug Administration (FDA) included virtual trials in its draft guidance on increasing patient diversity in clinical research. A key part of the FDA’s guidance is to work to reduce the amount of site visits required for a trial and leverage new technology to design better trials, reaching new patients to foster a more inclusive environment which in turn will lead to better data and higher-quality trials.
It’s important to note that these barriers serve more to inform which trials are more appropriate for virtual technology rather than whether Decentralized Clinical Trials are beneficial as a whole. Of the 55,000 trials in flight, some are good candidates for a fully decentralized model while many others can be managed in a hybrid model. Patients can be recruited and consented remotely. Physician “visits” can be conducted remotely via telemedicine. Data can be captured remotely (and frequently) via medical devices and mobile technology.
The good news is that technologies that are needed to improve patient access and experience are here now. Pharma and biotech organizations must be proactive in understanding the shifting digital landscape that enables this model. At its core, decentralization of clinical trials can generate immense benefits such as increased patient-centricity, resource management efficiency, and more robust and accurate clinical study results.
Reducing trial timelines has to be a long-term industry imperative, and digital technology can help valuable research continue to move forward, which has proved during the last months of Covid-19 pandemic.