Decentralized Clinical Trials: A Much-Needed Plan for a More Reliable Future

Clinical Researcher—April 2020 (Volume 34, Issue 4)

SCIENCE & SOCIETY

Al O. Pacino

 A new foundation is being set for clinical research where connectivity and responsiveness are prioritized. Patients and clinical research staff can experience fewer obstacles and more time participating in therapeutic breakthroughs by maximizing the use of global data privacy and security tools. Rapid innovation has brought us to this moment, and it’s time to embrace the future of clinical trials.

Clinical research professionals working at all levels for sites, sponsors, and vendors are currently facing significant challenges related to COVID-19. Hospitals and other health-related organizations are feeling the pressure of overcrowding. Clinical trial sites are still expected to maintain regulatory compliance while also delivering efficient care. Governments are rapidly adopting or developing plans of action that require businesses that handle personal information to have individuals “own” their data.

Businesses and hospitals are also expected to comply with “social distancing” efforts while providing the necessary tools to care for patients. With the demand for vaccine development and need for healthcare workers’ attention at an all-time high, we need to look at all options. It is time to seriously consider decentralized clinical trials and telemedicine as modern-day solutions to addressing not only the existing pandemic, but as tools and tactics to be integrated as ongoing, reliable tools in the clinical research industry.

Telemedicine: Improving Participation, Increasing Care

Several health insurance plans now offer telemedicine as an added service among their coverage. Companies such as Lyft are providing transportation services to those who need to commute to their clinical appointments via their mobile app. Decentralized clinical trials are getting a second look based on the COVID-19 impact and the overall direction of the high-speed, tech-driven economy.

The demand for these types of services have only increased due to a variety of factors. Requiring many staff and patients to be at home in isolation means many new needs are arising to be met with innovation. It is becoming essential to keep clinical research robust by creating space for global service providers to “meet” all in one place for the benefit of every professional tied to this vast enterprise.

An industrywide goal ought to be the development of specific guidelines and standards for the success of decentralized (or virtual) clinical trials. Consequently, establishing direct lines of communication between patient and staff can also increase the success and popularity of telehealth methods. Normalizing the electronic exchange of patient records and data seems to be inevitable, especially when there is strong enforcement of lockdown ordinances during moments of crisis.

Decentralized clinical trials are providing the infrastructure necessary to adapt to the needs of patients and clinical research staff. An added benefit of decentralization is that it addresses the need of decreasing data variance. Patient populations, many of whom are currently quarantined in their own homes, are in a moment where help is often needed and the potential to provide care is abundant. Existing technology, when combined with strategic marketing, can allow researchers to grow the diversity of their pool of patients and as a result help with the data variance issue.

General Data Protection Regulations: Protecting Health, Security, and Competencies

Currently, too many barriers exist in the early stages of clinical trials for decentralized trials to achieve time-sensitive outcomes. Standardization of telebusiness guidelines can help lower the time it takes to get a product to market.

The ability to assess proposed telehealth solutions based on industry-generated guidelines could pre-empt and decrease the bureaucratic requirements of regulators such as the U.S. Food and Drug Administration. Standards can fold in the regulatory expectations of the General Data Protection Regulation (GDPR), which compels organizations handling personal data to be accountable to users submitting their information. Most businesses are managing their clients’ information via decentralized platforms. It would be to the benefit of clinical research organizations around the globe to keep in mind the stringent demands of GDPR and to have the necessary data protection staff and protocols in place.

A step that can be taken is to create an online mechanism where decentralized trials and telemedicine companies are able to professionally align compliance requirements, while finding common ground for tackling areas of focus for research. Streamlining existing electronic siloed systems is going to save many professionals time, money, and resources that are becoming more precious by the day. Efficiently handling the modern demands of data safety and limiting data variance in our current environment is essential for creating site sustainability.

Conclusion

Technology that allows for the sharing of data across the healthcare and clinical research ecosystem has often been met with heavy amounts of skepticism. As a society, we experience innovation in other areas of our lives. By establishing standards, we can begin to embrace more of these solutions and to deliver to patients and survivors the sense of ease and simplicity they deserve when it comes to receiving care.

The clinical research industry is on the frontlines of leading all of us to a new world where—regardless of location, race, gender, or socioeconomic status—a relationship between clinical research staff and patients can be made. However, it is becoming an imperative to limit the number of in-person attendance at sites for the sake of a clinical trial. We must protect as many vulnerable populations as much as possible, particularly in light of COVID-19.

Now more than ever, it feels vitally important to be part of the solution in the fight to save lives.

Al O. Pacino is President at BlueCloud® by HealthCarePoint Professional Collaborative Networks, based in Cedar Park, Texas, and a former member of the Editorial Advisory Board for ACRP.

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