Why DCTs May be the Future of Clinical Trials

For modern sponsors and CROs, decentralized clinical trials (DCTs) have increasingly become a strategic priority, especially after the COVID-19 pandemic. 

Once perceived merely as nice-to-have pilot projects, DCTs, which are basically trials that are conducted remotely, outside traditional study sites, and through local healthcare providers with a view to improving the patient experience, first came into being when Pfizer launched a virtual trial back in 2011. Now, the global Decentralized Clinical Trials (DCTs) market size is projected to reach US$ 16290 million by 2027, from US$ 6106 million in 2020, at a CAGR of 14.8% during 2021-2027.

With patient centricity becoming the core foundation of modern clinical trials, decentralized clinical trials are increasing in popularity as they offer a patient-centric approach that addresses patient needs which often go unmet in traditional trials.

DCTs are also beneficial for sponsors as they accelerate clinical development and enable more representative patient access. They also develop a stronger evidence package than traditional trials. But DCT implementation is not an all-or-nothing situation with many DCTs combining remote and in-person activities to make the clinical trial participation process easier for the patient. Despite the operational challenges that may surface because of decentralization, the benefits of DCTs far outweigh the investment. Read on as we discuss why DCTs may be the future of clinical trials. But first, let’s start with a little context-

What is a Decentralized Clinical trial (DCT)

A decentralized clinical trial (DCT), also known as a virtual clinical trial or remote clinical trial, is a type of clinical trial that leverages digital technologies to conduct various aspects of the trial remotely, rather than relying solely on in-person visits to a physical study site. 

In a decentralized clinical trial, participants have the flexibility to participate from their own homes or local communities, reducing the need for frequent visits to clinical sites. These trials typically incorporate technologies such as mobile apps, wearable devices, telemedicine platforms, and remote monitoring tools to collect data and facilitate communication between participants and researchers.

Key components of a decentralized clinical trial may include:

1. Remote participant recruitment: Utilizing online platforms and digital advertising to reach potential participants and screen them for eligibility remotely.
2. Remote consent process: Employing electronic informed consent methods that allow participants to review and sign consent forms electronically, often through secure online platforms.
3. Remote data collection: Leveraging wearable devices, mobile apps, and other remote monitoring tools to collect patient data such as vital signs, symptom assessments, medication adherence, and patient-reported outcomes.
4. Telemedicine visits: Conducting virtual visits between participants and healthcare providers or study coordinators through video conferencing or telemedicine platforms, allowing for remote assessments, discussions, and monitoring.
5. Direct-to-patient medication delivery: Ensuring that study medications or investigational drugs are delivered directly to participants' homes, eliminating the need for on-site dispensing.
6. Remote safety monitoring: Employing remote monitoring tools to track participant safety and detect adverse events or side effects.

Decentralized clinical trials offer several potential advantages, including increased participant diversity, improved accessibility for individuals with mobility constraints or those living in remote areas, reduced burden on participants through flexible scheduling, and potentially faster enrollment and data collection. However, they also pose unique challenges related to data security, participant compliance, technological infrastructure, and regulatory considerations.

DCTs are the Future

There are four primary drivers that clearly state how DCTs are here to stay, even in a post-pandemic world.

Regulatory direction:

Regulatory agencies inclusive of the FDA and European Medicines Agency have made clear statements regarding key decentralized modalities, such as telemedicine across state lines, direct-to-patient investigational product shipments, etc. The FDAs Digital health center of Excellence and legislative direction to advance the use of DCTs is a clear indication of a smoother regulatory landscape for DCTs in the future.

Technology maturity:

The massive developments in modern technology powered by record-level VC investments in digital health are also enabling trial decentralization. In addition to this, horizontal and vertical integration among tech solution providers is resulting in the creation of more end-to-end technology solutions to power DCTs.

1. Pharmaceutical investment and capability building- Pharma companies are creating dedicated DCT capability teams with focused leadership. These companies are also investing in technology and processes to conduct DCTs at scale.
2. Patient Experience- The increase in the usage of digital healthcare such as telemedicine and digital pharmacies by patients has increased the expectations they have from a clinical trial experience, (which will not revert going forward).

The Pros of DCTs

DCTs offer a more streamlined experience by reducing the burden of time-consuming in-person visits to trial centers and offer wider patient access, especially in underrepresented and rural communities.

Just like patients, sponsors also benefit greatly from decentralized trials. According to Pharmafile, 85% of trials fail to finish on time with sponsors having to shell out upwards of $8 million per day. Decentralized trials can eliminate these hurdles by speeding up the recruitment process, reducing drop-out rates, and increasing compliance.

Also, by collecting high-quality clinical and real-world data through DCTs, sponsors can build stronger, more compelling evidence packages to better convey the value of the treatment for patients. Sponsors can also use novel digital touchpoints to generate unique label claims through DCTs.

Key Considerations in DCT Implementation

Sponsors opting for DCTs must root their decision in a deep sense of empathy and understanding of patient needs and the desire to offer quality patient experiences. By designing solutions that reduce the burden on patients and provide intuitive behavioral incentives for patients, sponsors can acquire better patient engagement and augmented trial performance levels. It is also essential to consider that sites will remain crucial to the patient experience. As sponsors develop DCT solutions, implementing solutions that adapt to site workflow and capability is key to trial success. Acquiring the right digital capabilities is also essential to a successful DCT. Digital solutions must offer a unified user experience and a single source of truth for data integration. 

Finally, given that DCTs are cross-functional, collaboration is a key requirement across trial design, operations, digital health, innovation, and regulatory functions. These teams must work together to break functional silos and establish new methodologies of working to successfully drive DCTs. Sponsors are required to establish consistent processes to enable scaling DCTs right from proof-of-concept to organizational capability. Organizational knowledge sharing is key here allowing teams across functions to apply learnings, adapt quickly, and act accordingly.

So Where Do You Start?

For sponsors considering implementing a DCT, combining business needs and decentralization feasibility between therapy areas can act as a reference point. Based on factors like administration route, assessment procedure, and whether the condition is chronic or acute, certain therapy areas are a better fit for decentralized trials.  

For many therapy areas, complete decentralization may not still be feasible or even right for patients but by identifying specific procedures that can be decentralized, sponsors can greatly improve the patient experience and move clinical trials closer to the patient.

But wait. For a successful DCT, you need a technology infrastructure that can match the demands of your trial. The future of clinical trials holds tremendous promise for advancing medical research and improving patient care. The integration of big data, virtual and decentralized trials, AI and ML technologies, adaptive trial designs, and patient engagement will reshape the landscape of clinical research, making it more efficient, inclusive, and impactful. At Octalsoft, we have already begun stepping into the future with our comprehensive suite of eClinical software solutions. 

Do you want to know how you can overcome existing clinical trial challenges, accelerate the development of innovative therapies, and usher in a new era of evidence-based medicine that benefits patients worldwide with Octalsoft? Book a Demo with us Now!