At this year’s Outsourcing Clinical Trial South California 2017, Novotech Director Mr Barry Murphy presented an overview of recent regulatory changes in Asia, highlighting the resulting unique clinical trial benefits available within the region, to an audience of leading US biotechnology companies.
"In the past four years, the number of clinical studies undertaken in Asia Pacific* has increased over 2.5% per year, compared to a 0.2% decrease in other Rest of World (ROW) locations[1].” said Novotech Director Mr Barry Murphy, “One of the driving reasons behind this increase is the intensifying competition between Asia’s clinical trial industries. Governments within Asia recognise the positive economic and healthcare benefits a robust clinical trial industry can deliver, and are making moves to further support their own domestic industries. Collectively, they are focusing on simplifying regulatory approval processes; increasing government support and clinical trial industry infrastructure; and promoting the potential healthcare benefits of clinical trial participation.”
“When considering in which region to next run a clinical trial, there are three key benefits available in Asia which need to be highlighted[2]:
- Clinical trial resources: Asia is home to large treatment-naive patient pools; numerous clinical trial centres with advanced equipment and technology; and comparable incidence and prevalence of Western diseases – China for example has one of the highest incidence rates for both liver malignancies and digestive cancers.
- Clinical trial capabilities, speed and worldwide acceptability of data generated: Asia’s Key Opinion Leaders provide attractive clinical trials environment and facilitate speedy trials. Data from clinical trials in Asia is routinely accepted as part of US FDA and European Medicines Agency regulatory submissions.
- Cost-effectiveness: Clinical trial related costs in Asia are generally 30-40% lower than the US and European countries; while low healthcare spend by many Asian governments makes clinical trials participation an attractive way for patients to access innovative therapies.
“Over the past year, several Asian countries have worked hard to address their specific clinical trial industry challenges,” Mr Murphy outlined, “When considering Asia for your next clinical trial, working with a regional CRO can make all the difference to your clinical trial success. A regional CRO’s country-specific experience will be able to guide you and ensure time is not wasted when engaging with each country’s unique and changing regulatory environment.”
As the leading Asia Pacific CRO, Novotech continues to grow in the region with the:
- Launch of a site monitoring (SMO) business to support clinical trial activity in South Korea and Taiwan
- Signing of two MOUs with leading clinical trial networks in South Korea
- Launch of a central labs service in Australia
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For more information about the untapped clinical trial benefits available in Australia and Asia,
Download a free copies of the Frost & Sullivan white papers, ‘Asia: Preferred Destination for Clinical Trials’
Or feel free to contact us.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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[1] Source: Clinicaltrials.gov. Data extracted on 17 June 2017. Trials with ‘unspecified’ location were excluded / IPD database – data extraction on 14 September 2017. * Excludes Japan.
[2] Frost & Sullivan white paper, ‘Asia: Preferred Destination for Clinical Trials’