Three Strategies to Take Your Clinical Trials into the Future

Key takeaways:

• Diversified and decentralized clinical trials (DCTs) have emerged to address the limitations of traditional clinical trials.
• Incorporating technology can help make DCTs successful and centered around the patients.
• Data collection and shifting regulations have opened new opportunities for real-world data (RWD) utilization.

For more on this topic:

• Learn about how PINC AI™ Applied Sciences and the PINC AI™ Innovation and Research Collaborative can help with your DCT strategy.

Traditional clinical trials have many challenges ranging from delays in recruiting to timelines to lack of patient diversity and spiraling costs. The COVID-19 pandemic only illuminated these problems as researchers worked around lockdowns and stay-at-home orders to recruit qualified patients. These challenges point toward the need to focus on research and study formats that reach people where they are, increase diversity, maintain flexibility, and accommodate technology and direct data sources.

Decentralized clinical trials (DCTs) have emerged to address these challenges. DCTs, which augment or replace traditional in-clinic approaches with direct-to-patient (DTP) and general practitioner interactions and data-driven alternatives, have seen more widespread adoption due to the increasing emphasis on in-home care, ability to access greater patient populations and driving to lower overall costs.

What is a decentralized clinical trial?

DCTs have been defined as studies executed through telemedicine and mobile/local healthcare providers, using processes and technologies differing from the traditional clinical trial model. They offer a strategy for technology-enhanced clinical trials that are more accessible to patients by moving clinical trial activities to a wider variety of settings, including telehealth and remote patient monitoring options.

What strategies do life science companies need to have in place to use DCTs?

The goal of a DCT is to expand clinical trial access to patients and providers at their convenience, thus increasing diversity and inclusion, accelerating patient enrollment, improving retention and potentially shortening clinical study timelines.

To do this, life science companies will have to embrace these three clinical trial strategies:

1. Incorporating Technology

Technology is key to delivering a DCT that accounts for proper management of trial product supply and ensures patient compliance and adherence. Life sciences companies will need to incorporate smartphones, wearables and access to tele-visits in conjunction with home healthcare providers, nurses, mobile phlebotomists and other local healthcare providers.

Attention must be given to integrating clinical trial activities that can be completed in a more flexible manner as well as using artificial intelligence (AI) and natural language processing (NLP) tools to identify a diverse set of eligible trial participants.

2. Collecting Data

Life science companies will have to work closely with a bevy of patient services to ensure accurate collection of data. Some of this patient data will be fed directly from patients through mobile devices, in-home and in-clinic visits or extracted from electronic medical records (EMRs) and will need to be aggregated and translated into study reports and prepared for regulatory review.

This data can often be unstandardized and difficult to use. Making that data usable for reporting purposes will require technologies that can provide translation and formatting that is both consistent and accurate. NLP technologies can help access this unstructured data, like clinical notes, and make it more usable for researchers.

However, managing this data, whether from multiple trial sites or through digital technologies, will ultimately require intuitive, fit-for-purpose technologies, regulatory requirement expertise or a partnership with a data science company.

Life science companies have been exploring the use of real-world evidence (RWE) based on real-world data (RWD) to help reduce expenses, time frames and complexities associated with bringing a medical solution to market. Now, more regulatory agencies are recognizing the promise of RWD. Many believe RWD combined with clinical trial research can help shorten the regulatory approval process and increase chances of U.S. Food and Drug Administration (FDA) approval or European Union Medical Device Regulation approvals.

3. Easing the Burden on Patients

Life science companies will need to work with sponsors or partners on protocol design to incorporate patient centeredness and decentralized components to help ease the burden on patients.

DCTs make it easier for patients to participate on their time from the comfort of their own environment using technology that assists with medication reminders and study-specific educational information. The increased ease of trial access, activities and patient centeredness ultimately leads to greater patient retention which is critical to maintaining study timelines.

Out of the clinical trial participants recruited in various traditional studies a dropout rate of 30 percent is generally observed, resulting in not only the loss of a participant but also a financial loss due to services rendered and the burden to enroll a new patient. Utilizing patient centered activity helps keep participants engaged and motivated to remain in the trial until completion.

Not only are DCTs great for patients, but they help researchers access broader patient populations in varied demographics, reduce geographic barriers and provide increased access to patients with rare diseases. In addition, DCTs positively impact life science companies’ bottom lines by lowering overall research costs via reducing the need for an investigator, on-site staff for dispensing medicinal products, storage expenses and stipends for participant travel to and from the site.

DCTs highlight the importance of collaborations and partnerships with networks of hospitals and health systems that can provide access to research ready sites and populations of eligible patients. When trials are patient-centered with a focus on embracing technology, we can expect decreases in trial costs and accelerated timelines.

How can life science companies partner with PINC AI™ Innovation and Research Collaborative (PIRC) to utilize DCTs?

PIRC is a scalable and rapidly deployable model for clinical research, currently consisting of more than 278 leading research sites across 38 states that leverage shared clinical technology and data to enable faster identification of eligible patients and rapid-cycle research for compressed study timelines and increased speed to commercialization.

How is PIRC changing the future of clinical research?

PIRC aims to optimize healthcare and its delivery through research and collaborative efforts. Using solutions and research powered by multi-dimensional data, they can quickly provide RWE and insights that help advance clinical research.

PIRC is part of PINC AI™ Applied Sciences (PAS) and collaborates with health systems, pharmaceutical, diagnostic and medical device companies to:

• Generate real-world evidence that accelerates care alignment with evidence-based guidelines.
• Co-develop solutions with members.
• Conduct retrospective research, RWE councils, prospective research and clinical trials.
• Publish research work in established, nationally recognized publications.

How can a life sciences company accelerate discovery with PIRC?

Collaborating with PIRC can help partners accelerate discovery, development and deployment of therapies. PIRC combines the knowledge of health systems that manage more than 2,150 acute and non-acute care facilities in urban and rural areas in more than 15 states covering all nine geographical regions of the U.S. PIRC members bring a wealth of experience and perspectives on research and clinical trial operations, innovation, information technology, data-analytics and business development.

PIRC focuses on four key areas:

• Research: PAS and PIRC work with partners ranging from pharmaceutical and medical device companies to the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), United States Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). Each of these organizations has leveraged the breadth and depth of the PINC AI™ healthcare data to help characterize illness and clinical outcomes, find better treatments, improve outcomes or assess the impact on healthcare service delivery and quality.
• Innovation: PIRC strives to test new ideas and technologies to build sustainable solutions for the healthcare and research industries. It works to expand access to innovative tools that can assist partners through simplifying the research trial candidate identification process and providing comprehensive workflows built into clinicians’ processes.
• Collaboration: PIRC collaborates to improve offerings and health outcomes for populations across the nation through sharing ideas, innovations and research studies in order to help scale best clinical practices.
• Premier Partner: PAS cultivates strategic partnerships between life sciences companies and health systems to co-innovate solutions and strategies that transform healthcare. PIRC aims to help research teams decipher data into meaningful insights and arms researchers with diverse tools to help them address challenges and change the way healthcare is developed and delivered in our communities.

For life sciences companies to embrace and make DCTs successful, it will require a more open, information-sharing ecosystem involving public and private data resources, incorporating a data governance framework, potential partnerships and embracing a willingness to integrate technology-enhanced solutions.

Decentralization won’t fix all clinical trial problems, but by focusing on the patient and embracing technology, we can expect decreases in trial costs and medical solutions that lead to solutions to enhance clinical performance and promote better, more equitable health outcomes.

Just like in other industries, engagement is critical, and competitors are continually evolving. Investment in a DCT strategy can help improve life sciences resilience and research efforts and deliver strategic returns.

The insights you need to stay ahead in healthcare: Subscribe to Premier’s Power Rankings newsletter and get our experts’ original content delivered to your inbox once a month.