“Nations that permitted DCT (Decentralized Clinical Trials) practice will continue to speed up their trial completion rate, delivering life-saving therapies to patients quicker. Korea (and other nations with DCT hesitancy) should seriously consider these technologies, or they risk falling behind the unprecedented innovations happening globally in the life sciences industry.”

Kelly McKee, vice president for DCT and Patient Registries at Medidata, said so in a recent interview with Korea Biomedical Review.

She emphasized that compared to existing clinical trial methods, DCT can recruit patients more easily, is more cost-effect, and is safer, emerging as a new paradigm in clinical trials.

According to a report released by GlobalData in June 2020, about 35 percent of global medical experts use DCT, and the other 65 percent plan to do so. In addition, regulatory agencies in many countries make detailed regulations and guidelines concerning DCT, such as general considerations, electronic consent, and direct delivery of medical products to subjects. However, the domestic outlook is not very bright. That’s because there are many negative opinions and regulations in Korea.

So, KBR heard about the initial process of using DCT in clinical fields and regulatory situations on clinical trials in various countries from Vice President McKee of Medidata, a global company that provides cloud-based solutions for clinical trials in life sciences.

Vice President McKee has developed new solutions to help increase patients’ participation before, during, and after clinical trials and improve patient communication for decentralized and hybrid clinical trials. U.S.-headquartered Medidata provides clinical trial-specific, cloud-based solutions for global biopharma companies, contract research organizations, and medical institutions to help them develop and commercialize smart treatments.

Question: During the Covid-19 pandemic, pharma companies experienced difficulty conducting clinical trials. What is the trend of global clinical trials for the past three years?

Answer: Due to the pandemic and the global lockdown, many life-saving trials ended. Since patients, sites, and sponsors could not complete their trial tasks through the traditional method, sponsors, and CROs turned to decentralized clinical trial (DCT) technologies (such as eConsent, video visits, and electronic health outcome assessments), which allowed them to continue to collect important study data and engage patients.

The need brought to light during the pandemic illustrated the limitations of traditional clinical research practices and made many stakeholders realize the value of DCTs and patient-facing technologies. Globally, DCTs are increasingly adopted by sponsors and CROs, and today, both FDA and EMA have published recommendations on conducting DCTs and hybrid studies. The demand for DCT technologies has unquestionably risen over the past three years since the Covid-19 period and is expected to become normalized within the clinical research industry.

Q: However, some countries, including Korea, are still cautious about introducing DCT. What is your opinion as an expert in the clinical trial industry?

A: Korea’s hesitance towards adopting DCTs may be a “chicken or egg” problem. The Korean government has tight restrictions on virtualizing clinical trials, and not all clinical research stakeholders in Korea are on board with the adoption of DCTs. For instance, in a survey study by Kim Young-Sang, many site investigators were reluctant to change their traditional clinical trial method due to their unfamiliarity with the DCT technology. In addition, many did not see the benefits for patients.

On the other hand, sponsors were more supportive and prepared to carry out DCTs. This paper suggested that the Korean government must gather opinions from clinical research stakeholders and change regulations to implement the DCTs successfully. A consensus between sites and sponsors might be achieved if the government eases regulations and federal agencies provide the appropriate guidelines for DCTs, like in many other countries.

DCTs are powerful tools that can be leveraged to improve the clinical research process. Medidata has consistently demonstrated the benefits of DCTs for patients, sites, and sponsors over the past years. DCTs ease trial tasks for patients, empower them with knowledge and increase accessibility. For sites, DCTs provide real-time data and enable quick action in case of patient safety concerns. Finally, DCTs can significantly reduce costs and study completion timelines for sponsors.

Although the benefits clearly outweigh the potential risks, the challenge lies in convincing stakeholders that these benefits are real and that DCTs can be integrated into the clinical trial process in a way that is safe, secure, and compliant with all relevant regulations. This requires education, clear guidelines, and cooperation from all stakeholders. However, by working together, we can all ensure that DCT technologies become a standard part of clinical research in Korea.

Q: How did countries that allow DCT change existing regulations? Please explain with examples.

A: Countries receptive to integrating DCT technologies have adapted their regulatory frameworks by adding new guidance documents and recommendations. Initially, most of these regulatory guidance documents were written in response to the Covid-19 pandemic, but some regions have since issued guidance beyond the pandemic.

In December 2021, the U.S. Food and Drug Administration (FDA) published ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,’ which guides the remote collection of clinical research data through digital health technologies such as mobile devices and software. The guide covers the selection of digital health technology, the rationale for clinical investigation, risk considerations when using digital health technologies, and record protection.

Meanwhile, some countries have developed guidelines specific to DCT. Examples of countries with published DCT guidelines include Denmark, Sweden, Switzerland, and China. The European Medicines Agency (EMA) has also published guidelines on DCT practice. In addition, Denmark was the first country in the world to publish a dedicated DCT guidance document in 2021. This has since been updated and revised and includes sections on general DCT implementation considerations, sections dedicated to elements such as eConsent and Direct to Patient delivery of the investigational medicinal product, and others. The industry welcomed this guidance document as a helpful tool in navigating the complex and ever-evolving regulatory landscape.

Sweden’s pilot project on DCTs outlined some questions and answers on the acceptance and best practices for DCT elements implementation. In addition, Switzerland released a position paper on DCTs, outlining DCT best practices and important considerations. China marked the release of three guidance documents for consultation in the summer on patient-centered clinical trials, with topics focused on elements commonly referred to as decentralized, including eConsent and direct-to-patient delivery of investigational products.

The European Medicines Agency (EMA) also published a recommendations paper on decentralized elements in clinical trials, with best practices and an overview of country-specific acceptance of each element as part of the bigger effort of Accelerating Clinical Trials in the EU (ACT EU project).

These individual DCT regulatory publications are part of a wider global wave of regulatory movement to provide clarity and guidance on DCTs, and other novel trial approaches.

Q: Patient participation is essential for the stable settlement of DCT. How does this work in Medidata DCT systems?

A: Despite having an estimated 58 million clinical trial openings globally at any given time, only two million people participate every year. In addition, based on the CISCRP’s 2019 and 2021 Perceptions and Insights Study, only 25 percent of surveyed individuals feel “very confident” in their ability to find a clinical research study that is right for them, and 95% of the participants who completed a trial are willing to participate in another study.

However, participants report they never hear back from sites or sponsors after study completion regarding the new clinical trial opportunities. These numbers reveal the issues surrounding the general public’s access and awareness of the opportunity to participate in clinical trials; Medidata is focused on closing this gap in clinical trial participation.

Medidata’s DCT program addresses the challenges highlighted above through the myMedidata platform. This engages patients pre-trial, in-trial, and post-trial. Ultimately, our platform empowers patients with awareness, knowledge, and confidence, resulting in higher numbers of research-ready participants, further supporting the stable settlement of DCT globally.

Q: How is the safety of patients participating in DCT managed?

A: With the increasing prevalence of DCTs and the rising complexity of clinical trials, Risk-Based Quality Management (RBQM) became widely adopted by sponsors and CROs to ensure the safety of trial participants and minimize risk to trial integrity. RBQM is a holistic systems-based approach to trial management that focuses sponsor/CRO resources and oversight on the biggest risks to a clinical study.

The organizations that have already implemented RBQM into their trial design during the pandemic successfully withstood many of the challenges brought by the pandemic in conducting clinical research. In contrast, other life-saving trials that did not adapt came to an unfortunate halt. RBQM practices that enabled successful trial execution and completion include centralized monitoring, flexible on-site interaction, and remote data collection. The COVID-19 vaccine trials are an excellent example where RBQM practice in clinical trials delivered new treatments to patients around the globe efficiently without compromising patient safety and trial integrity.

Furthermore, decentralized clinical trials allow for the collection of eSource data. eSource is electronic data collection in clinical trials, replacing traditional paper-based methods. Through eSource, patients can participate and provide data using remote technologies such as smartphones, wearable sensors, and eCOA. By utilizing eSource and decentralized technologies, patients will have improved accessibility and flexibility to participate in trials, and investigators can capture real-time patient data. In addition, this adds a layer of patient safety since sites can respond immediately in case patient safety is compromised.

Q: Do you think DCT will be maintained even after the Covid-19 pandemic? If so, why?

A: Over the past few years, the view toward DCTs have shifted from possibility to necessity. DCTs were needed to sustain global research programs during the unprecedented pandemic. The experiences using DCTs shed new light on the inherent obstacles in traditional clinical research participation and the benefits of decentralized capabilities. Both the FDA and EMA published recommendations on conducting DCTs, allowing sites and sponsors to use this novel technology while maintaining trial integrity and patient safety.

Evidence points to DCTs as a more patient-centric solution than the traditional method, allowing patients to participate in clinical trial activities from home and providing access to clinical trials to the broader population. Given the benefits and rising demands for virtualizing clinical trials, enabling DCT technologies will most likely become a normalized practice in clinical research.

Q: Some say that DCT will not be as valuable in Korea as in other countries because Korea has a well-equipped medical infrastructure and is not far from the clinical trial site. What is your opinion on this?

A: Having a well-equipped medical infrastructure does not necessarily remove the inherent obstacles of traditional clinical research methods. In traditional methods, patients will have to travel to the site for visits, data can only be collected during the periodic site visits, and sponsors will have to travel to sites to complete their monitoring tasks, all of which add unnecessary burdens that could be solved through DCTs.

DCTs can allow stakeholders to complete trial tasks anywhere and capture data that provides better insight into patients’ health and trial progression. Nations that permit DCT practice will continue to speed up their trial completion rate, delivering life-saving therapies to patients quicker. Korea (and other nations with DCT hesitancy) should seriously consider these technologies or risk falling behind the unprecedented innovations happening globally in the life sciences industry.

Q: How do you expect clinical trials to change in the future?

A: Innovation in clinical research is imperative to meet the demands of patients in need of life-saving therapeutics. During the unprecedented pandemic, DCTs were the innovative solution that sustained research programs around the globe. Today, growing arrays of digital health and medical technologies enable DCTs, allowing more countries to participate in clinical trials and increase investigative sites globally.

However, the growing number of stakeholders and their associated demands inevitably complicate clinical research, presenting various challenges, including the need to handle a large volume of data for ingestion and analysis, navigate disparate systems utilized by stakeholders, and deal with a complex study design, among others. As the demand for decentralization and complexity in clinical research continues to rise, the industry’s DCT solutions must continue supporting the growing demand and innovation.

Not only do DCTs address the growing complexity of clinical trials, but they are a potential key to acquiring better insights into patient health and the effectiveness of novel drugs being investigated. For instance, eSource and EMR integration can aid sites in collecting patient data without the need for duplicative data entry with improved quality. In addition, although clinical trial data provide robust insights into outcomes specified by study protocols, they may not always represent the broader population in the real world. By linking clinical trial data to real-world data, including existing health data repositories (such as EMR), and using wearable sensors capable of continuous data capture in the patient’s daily life, investigators can expand their understanding of patient health beyond the data collected during clinical trials.

In short, DCTs will significantly enhance drug development with better patient insights, ultimately leading to better treatments and improved patient care.

Innovation is essential to furthering human health. At Medidata, we’ve been redefining what’s possible in clinical trials for over 20 years. As a result, only

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