By following a procedure of analysis, planning, execution and closure, making Asia a desirable location for clinical trial sponsors. However, before they and their CRO partners rush into starting or expanding an Asian clinical programme, both parties should first address several strategic issues.
With every aspect of drug development moving east, there are only two kinds of clinical trial sponsors: those running sites in Asia, and those thinking about running sites in Asia.
For the latter, Asia appears from afar an impenetrable black box. While that box is rumoured to hold significant cost savings and access to the fastest-growing healthcare market in the world, tapping into it means navigating regulatory and operational challenges compounded by language barriers.
Even for drug developers with established clinical trial sites in Asia, expanding from one country to the next can pose challenges. Each country has its own distinct cost structure, population base, medical practice standards, infrastructure, government policies and cultural differences.
Before delving into or expanding an Asian clinical programme, trial sponsors and their CRO partners should discuss several strategic issues.
Running trial sites in China, Thailand, the Philippines or Malaysia can save a sponsor 60% compared to running equivalent sites in the U.S. Most countries in Asia are at least 20-30% more cost-efficient than their western counterparts. But there are exceptions to every rule: for instance, investigator salaries and other trial costs in South Korea can be just as high as in the western world.
With more than four billion people, Asia offers sponsors a deep pool from which to draw clinical trial participants. Yet sponsors of late-stage trials in indications such as diabetes or cardiovascular disease must balance population benefits with increasing competition for enrollment in countries such as China, Indonesia, Japan, the Philippines, Thailand and Malaysia. A country such as South Korea is less populous, but may also offer less competition.
There are certain diseases for which the standard of care in Asia is similar to that in the West, including breast cancer, lung cancer and diabetes. But for many indications, medical practice standards differ both from east to west and between the different Asian regions. Sponsors seeking to mirror Western standards may want to consider limiting their trial sites to countries such as Singapore, Taiwan, Hong Kong and South Korea.
Sponsors should be prepared that Asian trial sites may need more assistance when it comes to following protocol and differentiating between medical practice and clinical research. Similarly, sponsors should not assume that all potential Asian trial sites will have the infrastructure - even fax machines or freezers - needed for a clinical trial.
Each Asian country's policies on protocol approvals, insurance regulations, import licences and other factors can affect a sponsor's success. The regulatory bodies in South Korea, Taiwan and Singapore have adopted an FDA flavour to their practices. Yet each Asian country has its own regulatory idiosyncrasies - in China, for example, a sponsor should never assume that what worked in one application will be directly applicable to another. The cookie-cutter approach simply isn't feasible.
Once language barriers are overcome, sponsors are often pleased to learn that investigators in most Asian countries are eager to participate in clinical research. Regulatory reviewers, too, are often eager to help, if a sponsor knows what questions to ask and how to ask them. Yet there are certain cultural considerations sponsors need to address upfront with their investigators, such as procedures for publicising findings from the trial.
As the fastest-growing pharmaceutical market in the world, China is a major consideration in the marketing plans of most drug developers. Yet if a sponsor has no plans to launch a drug in certain Asian countries, then conducting clinical research in those countries may present ethical challenges.
The right CRO partner is aware of such ethical considerations and can guide sponsors through these and other issues. While challenging at first, Asia's rewards in terms of rapid enrollment, cost-savings and market access are not just upside - they are essential to remaining competitive in the drug development world of today and tomorrow.
With a long-standing history of therapeutic speciality and technological innovation, one company has transformed itself from a start-up contract research organisation into a drug development leader specialising in oncology, CNS and paediatrics, with full data services capabilities.
INC Research, a global contract research organisation, invests in its customers' success with proven therapeutic foresight and a trusted approach to advance drug and device development. The company's Trusted Process method of conducting phase 1 to 4 trials means its customers experience trial excellence, thereby helping to minimise potential risk factors and leading to more informed and confident development decisions.
Its seasoned project managers and clinicians deliver unsurpassed scientific expertise and service in a therapeutically focused environment, as well as in innovative pediatric trials. Pharmaceutical and biotechnology companies look to INC Research for functional outsourcing needs and to conduct complete customised worldwide trials that end with results of the highest integrity.
The teams at INC Research are built from the brightest people in the industry with years of therapeutically focused and industry-related experience, from the company's top scientists to its data entry group. By continually attracting the industry's most talented individuals, the company has emerged as a leading global CRO.
The high percentage of repeat business is a testament to the quality and dedication of the INC Research team.
A customer-centric focus is a clear, common objective across the entire INC Research organisation. Its full range of services, processes and technology are tailored to the needs of each client and their specific project requirements. For phase 1 to 4 clinical trials, INC Research provides:
INC Research offers a full spectrum of drug development services designed to support the unique needs of its customers. It is the disciplined approach of its Trusted Process, deployed to effectively execute customer programmes, that makes it stand out in the industry.
The four-part process, with specialised therapeutic expertise at its foundation, begins with planning and design where pre-study award activities are conducted in advance of contract execution. Thus, a selected team is fully prepared with feasibility and critical programme considerations from the start.
Phase 2 is QuickStart, the part of INC Research's process designed to enable the efficient movement of a project through the initial phases of a study. QuickStart provides the benefits of rapid cycle times on all project plans, building study ownership by the entire project team. Phase 3 is Programmed Acceleration, where active recruitment and intelligent or iMonitoring kick in, along with aggressive management of critical study data.
Finally, the process wraps up with QualityFinish, with customer deliverables presented as requested - on time and within budget.
With a presence in 32 countries worldwide, INC Research works from 20 offices across North America, Central, Eastern and Western Europe. Through a strong network of international CRO partners, the company has the global capabilities to deploy a study on any scale, on six continents.
Equipped with knowledge of local languages, culture and regulatory requirements, project teams at INC Research provide an unsurpassed level of support to investigative sites. Backed by strong clinical experience and therapeutic expertise, the company takes a highly flexible and customised approach to clinical research by listening closely to clients and tailoring services to their unique needs and projects, from select regional services to full-service international studies.
At INC Research, the commitment to bringing new drugs to market is intense and focused. The team understands the complexities involved in clinical programmes, and has the flexibility, expertise in a number of therapeutic areas and the in-depth understanding of the full development process to handle any aspect of these trials. Whether the scope of a project is a full-service international study or product development programme, or requires only select regional services, INC Research has the resources and expertise to meet all needs.
INC Research is based in Raleigh, North Carolina, USA, and its European headquarters is located in Maidenhead, England, UK.