Hong Kong - Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, will be presenting at the Clinical Research Governance (CRGo) World Conference & International Clinical Trial Center Network (ICN) Symposium 2023 in Hong Kong this month.
Michael Stibilj, Novotech's Chief Operating Officer, will discuss the potential, challenges, and practical applications of Decentralized Clinical Trials (DCTs) from a global biotech CRO perspective.
According to Michael Stibilj, DCTs offer an advantage in terms of potential for substantial patient recruitment and retention. Currently only 5% of eligible patients are participating in clinical research.
“The use of remote tools and methods show great potential for increasing trial efficiency and reducing barriers by facilitating participation outside of traditional clinical settings,” stated Mr. Stibilj.
He further mentioned that regulatory bodies are increasingly endorsing DCTs due to their capacity to enable patient participation irrespective of their location, eliminating logistical hurdles. This approach provides improved access to the study and the investigational product, allowing for the inclusion of more diverse and representative populations.
He detailed that the successful execution of DCTs hinges on advanced digital tools and technologies, including e-consent, applications, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, and the relocation of trial activities to the patient's home or nearby healthcare facilities. This shift involves passive monitoring devices rather than active data collection methods.
However, he noted that “key challenges recognized by regulators include concerns regarding investigator oversight and participants’ safety when physical examinations and face-to-face contact are limited”.
His conclusion emphasized that "as we venture into the next phase of clinical trial evolution, there lies significant potential for patients, investigators, regulators, and sponsors to cultivate trust and assurance in these novel approaches and technologies. This will foster greater synergies among these pivotal stakeholders within drug development".
According to the organizers, this year’s conference titled Clinical Research Success through Good Governance aims to facilitate communication and knowledge sharing within the global biotech research communities. It assembles professionals from academic and healthcare institutions, clinical and medical research organizations, the biomedical and pharmaceutical industry, as well as governmental agencies to discuss the latest trends in clinical trials governance.
The conference will be conducted in hybrid mode (online and in-person).
Date: 29 November 2023
Novotech presentation: 14:40 – 15:00 (GMT+8)
Title: Decentralized Clinical Trials: Potential, Challenges and Practical Applications
Novotech has more than 3,000 employees operating across 25 geographies, with 34 office locations, including the US, Greater China, South Korea, Australia, New Zealand, and Europe.
The CRO offers biotechs a unique and unparalleled suite of early to late-phase services across the US and Europe, with a foundation in Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.
Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023 and the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2022 and 2023 awards. Additionally, the company has been honored with the Asia-Pacific Contract Research Organization Company of the Year Award each year since 2006. Its commitment to collaboration is evident in the 50 Leading Site Partnership agreements it has signed over the past three years.
Media contact
David James
About Novotech Novotech-CRO.com
Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.
Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.
The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.
For more information or to speak to an expert team member visit www.Novotech-CRO.com