6 Ways to Make Decentralized Trial Implementation Easier

Let’s start by looking at some numbers- By comprehending the statistics related to the clinical trial process, sponsors and researchers can better understand common obstacles and take a proactive approach to conducting successful studies. Some key facts include:

• Approximately 80% of clinical trials are delayed or closed because of problems with recruitment
• 37% of sites under-enroll volunteers, and 11% fail to enroll a single patient
• Clinical trials account for nearly 40% of the US pharma research budget and total around $7B per year. The estimated cost of patient recruitment is 40% of the total budget, or $1.89B
• Delays can cost sponsors between $600,000 and $8 million for each day that a trial delays a product’s development and launch
• Screen failure rates are significantly costly for sponsors and the cost (on average) across the industry is roughly $1,200 per failure

Clearly, improving clinical trial patient enrollment and engagement is a critical need. 

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials by demonstrating their feasibility and benefits. While not all trials can or should be decentralized, this shift has prompted the pharmaceutical industry to embrace innovative approaches that are likely to continue shaping the future of clinical research.

Decentralized clinical trials (DCTs) can improve the patient trial experience, attract more diverse clinical trial participants regardless of where they reside, give greater flexibility, and reduce costs—all to bring safe and effective therapies to market faster. To reap the many benefits of DCTs, sponsors must focus on the promise of decentralization while lowering the burden for everyone participating in clinical trials, including patients, clinical research sites, and sponsors. Here’s how sponsors can enable a successful, patient- and site-centric DCT:

1. Design Your Clinical Trial Around Patients and Their Diverse Needs

70% of potential trial participants are projected to live more than two hours away from clinical trial venues. As a result, decentralized clinical trials can reach and attract a broader and more diverse pool of individuals. 

The burden of medical research involvement is reduced in part by optimizing a patient's clinical trial experience. The utilization of accessible, user-friendly training materials, the incorporation of virtual medical visits, and the inclusion of remote monitoring are all critical and required developments. Yet, from registration through post-study activities, the participant may be required to utilize several technologies with varying user interfaces, levels of complexity, requirements, and passwords.

Employing device-agnostic technology that allows for a single sign-on (SSO) to access all patient-facing, study-related activities alleviates this burden, especially for audiences with poor technological literacy. Octalsoft, for example, provides a single-destination patient portal that allows patients to virtually enroll and engage in clinical trial activities from any internet device.

2. Empower a Diversified Study Group by Enabling DCT Technology Reach

Clinical studies currently enroll fewer than 5% of eligible participants. DCTs provide the prospect of increasing clinical trial variety and providing access to patients who would otherwise be excluded from standard research.

Sponsors can deploy inclusive trial designs backed by novel DCT solutions by involving participants who reside in rural or underprivileged regions and have been excluded from traditional research due to the difficulty of in-person visits. Sponsors should work with community healthcare practitioners as partners, including non-traditional research locations that have built confidence with patients who are cautious of clinical trials.

Decentralized trials can also reach out to underserved patient communities by widening inclusion criteria in terms of ethnicity, age, gender, and sex. To promote the advantages of clinical research to underprivileged patient groups, clinical trial awareness activities should be targeted in places with varied demographics.

Octalsoft’s innovative suite of solutions enables sponsors to broaden their reach to increase minority participation in clinical research; eConsent, eCOA (clinical outcome assessment), and pre-and post-trial registries are just a few examples that help sponsors break down the barriers of traditional clinical trials.

3. Facilitate Flexible Supply Delivery Options

Dispensing investigational medicinal products (IMP) directly to a patient's home or chosen location is one of the most difficult barriers to eliminating patient burden in clinical trials. Sadly, there are several obstacles to Direct-to-Patient (DtP) delivery. Integration with depots and distribution facilities, guaranteeing time-sensitive and safe deliveries, tracking chain of custody, and ensuring blinding and other logistical considerations are just a few examples.

Giving patients more transparency and influence over the ordering and delivery of clinical trial supplies provides sites with more chances to boost patient participation and satisfaction. Enabling DtP also necessitates a grasp of regulatory regulations as well as a strong data platform capable of reliably tracking the chain of custody, ensuring patient blinding and dealing with various logistical problems to maintain compliance. 

Combining regulatory knowledge with high-quality technologies can be a significant step forward in lowering patient burden and enhancing patient retention in DCT studies. Sponsors should ensure that locations and research teams have full access to supply accountability.

4. Consider Sites’ Needs to Improve the Overall Clinical Research Site Experience

Sponsors must emphasize lowering site burden in terms of total DCT adoption when adopting decentralized trials—from the usage of new clinical trial technology to the needed study start-up procedures to properly execute each trial.

For example, much of the trial site load at the beginning is focused on training. There are several training sessions and back-end responsibilities that site workers must do. Keeping track of these needs can be tough for study coordinators, especially when exploring new portals and platforms.

Instead of merely installing new DCT technology, sponsors should examine how to make things easier for sites. One method is to assist and expedite the site training process. Even little adjustments, such as allowing for more flexibility in group training or utilizing a single sign-on clinical trial platform, may alleviate the load on sites and free up much-needed time to focus on clinical trial participant care.

Sponsors should engage with sites and learn about their preferences and concerns. Keeping an open line of communication is crucial for recognizing pain points and offering prompt help. Sponsors should engage with site personnel to retain patients as a priority and lessen the load of clinical trial operations by addressing site needs during DCT implementation.

5. Connect Patients, Trial Sites, and Sponsors on a Single Platform

A well-designed technology platform solution should take into account the demands of all persons involved in medical research, regardless of role.

A single data platform that sponsors, clinical trial participants, and locations can use decreases the risk of data re-entry, delays, and duplication. To enable successful clinical trial administration and supervision, data may be exposed anywhere, in real time.

A single DCT platform also makes it simpler for patients to interact and feel supported before, during, and after a trial, while also assisting sites with data collection, quality, and compliance.

Finally, Octalsoft’s Decentralized Clinical Trial solutions promote simplified and automated workflows, allowing clinical managers to move their focus from manual, repetitive duties to high-value data analysis and synthesis—a modernity they welcome.

6. Engage Support for Tailored Guidance and Easier Implementation

While the notion of a decentralized clinical trial has been around for a while, DCT technology adoption continues to lag. Several issues are at work, including sites' lack of experience with new trial designs, a lack of competence in updating regulatory advice, and outmoded technical infrastructures. Engageing support for tailored guidance and easier implementation is therefore imperative.

How Octalsoft Can Help

Sponsors may be cautious to embrace DCT capabilities for the reasons stated above. Octalsoft, a long-standing leader in the DCT field, is here to assist. We provide specialized, qualified advice on DCT trial design and implementation. Our industry specialists can lead a complete, multifaceted strategy to ensure organizational success and end-user uptake. Our objective is to assist sponsors in developing a long-term DCT strategy that is suited to their clinical trial requirements.

We trust that this post will prove informative. Schedule a Free Demo now to learn more about how Octalsoft can assist you in developing and implementing a decentralized clinical trial system that links trial experiences for patients, sites, and sponsors. You can also have a quick chat with one of our experts by following this Link. We look forward to hearing from you. Watch this space for more information, updates and fresh insights for your clinical trials in Octalsoft’s vast library of scientifically driven publications written by our team and industry key opinion leaders.