“CRO industry is well positioned to thrive in Asia”
At more than 4 billion people, the Asian population accounts for more than 60 per cent of the world population and carries an increasing disease burden in cardiovascular disease, cancers and Type II diabetes.
These patient populations were previously challenging to reach; expansion into the Asian market will give companies greater access. Now the governments are becoming more aware of the economic benefit and positive healthcare impact a growing clinical research industry can have. This expansion of trials has resulted in continued growth for the CRO market in the region.
As the number of clinical trials increases globally, the need for Asia as a region for clinical trial conduct and sites also continues to grow creating an intensively competitive trial landscape. There has been diversification among sponsor companies to file new drug applications in the Asian markets, requiring local trials and patients. In parallel, the governments are becoming more aware of the economic benefit and positive healthcare impact a growing clinical research industry can have. This expansion of trials has resulted in continued growth for the CRO market in the region.
At more than 4 billion people, the Asian population accounts for more than 60 per cent of the world population and carries an increasing disease burden in cardiovascular disease, cancers and Type II diabetes. These patient populations were previously challenging to reach; expansion into the Asian market will give companies greater access.
The Asian market has a reputation for having complex healthcare systems with a less uniform approach than the European Directive. Traditionally, one of the biggest challenges has been the variability in what is defined as a “healthy” normal, culture and healthcare infrastructure. However, this is changing. Technology driven countries such as Japan and South Korea are pairing with efficiency driven countries like China and factor driven countries like India, and together they are making progress in developing strategies that can overcome drug development hurdles in the region, particularly now that the market is open to making changes. Collectively, there has been a focus on simplifying regulatory approval processes, increasing government support, and improving clinical trial industry infrastructure.
The most significant growth in Asia’s CRO landscape can be seen in China. With a population of nearly 1.4 billion, and changes underway in their regulatory environment, the drug development industry is seeing a long-anticipated growth curve taking shape. In anticipation of an increase in clinical trial work, there has been some movement
of sponsors setting up hubs in Beijing and making investment in the development of the Chinese clinical trial environment.
In line with many other Asian countries, the regulatory environment in China is undergoing changes which will result in changes to the trial approval process, most notably, a reduced regulatory timeline to 60 days to run in parallel to ethics submissions, increased site selection flexibility, and the ability to utilize foreign data. This will improve the trial environment by making it simpler and less time consuming.
If China Food and Drug Administration (CFDA) regulatory reforms are enacted, China represents one of the largest potential growth regions for clinical trials and the CRO market in the next five years. The access to large numbers of patients, both disease specific and treatment naïve, in urban settings will continue to make China attractive for trials. However, Good Clinical Practice (GCP) and quality challenges can be an issue at trial sites with limited trial experience. Therefore, the use of Site Management Organizations (SMOs) and the provision of GCP training and site support will be critical to ensure high quality data is produced at these sites. In addition to CRO growth in the country, SMO growth will also be required to meet these needs.
From a resourcing perspective, Taiwan and Hong Kong will likely benefit from growth in China since both locations have demonstrated strong quality and talent. CROs will view both as a potential option to support training, monitoring support, leadership, etc.
In Japan, the clinical trial market is facing considerable challenges due to a lack of available, experienced, clinical trial resources. The rapid expansion of trials in Japan has put significant pressure on the labour market that supports these trials. Limited availability of experienced, Japanese speaking clinical and medical staff for direct site interactions, coupled with an outdated resourcing model by local CROs, has made reliable and consistent staffing a bottleneck for some providers in the country.
However, there continue to be collaborations between regulatory authorities in Japan and other countries in the region to accept early clinical supportive data as justification for Pharmaceuticals and Medical Devices Agency (PMDA) applications. The ability to share safety data between countries such as China, Taiwan, Japan and Korea may help streamline clinical trial applications as well as marketing applications in Japan. Both the limitations in available staff and the increase in demand for trial sites in Japan present growth opportunities in the country for global CRO market expansion.
Currently, approximately 1.4 per cent of global clinical trials are conducted in India; the country has a population of 1.3 billion and carries approximately 20 per cent disease burden in the world. This low percentage is the result of a previously unstable clinical trial environment.
The number of trials running in India peaked with clinical trial applications in 2010 however, changes to clinical trial regulation, and a lack of stability within India, resulted in a significant decrease in trial activity. Today the number of clinical trials in India has been steadily increasing and is expected to continue to grow in 2018-19 as a result of clinical trial regulatory changes that are helping them become more secure and predictable. The regulatory process has eliminated the three-tier approval system and now requires only a single approval following an electronic application, resulting in faster timelines and therefore faster access to patients.
South Korea continues to be a country of choice to conduct clinical trials. It has seen steady growth in the number of trials registered largely due to the country’s sophisticated infrastructure, high level medical care, and access to experienced staff. Korea has conducted more trials than any other Asian country in the last five years and has ranked in the top 10 countries in the world since 2011.
Singapore also continues to be a high-quality
country for clinical research. While there is significant investment and infrastructure to support clinical trials, participation remains limited due to its size.
The remaining Southeast Asian countries, (Malaysia, the Philippines, Cambodia, Vietnam, Myanamar, Thailand, Laos, the Indonesia, Sri Lanka and Bangladesh) all represent a small number of active clinical trial sites. However, with respect to populations and access to treat naïve patients, as well as certain therapeutic indications (tropical disease, infectious disease, certain cancers), these countries present excellent growth opportunities for CROs.
The challenge remains infrastructure, and access to well-trained clinical sites and staff. In many of these countries, the clinical trial models are still relatively new, and thus access to talent for CROs for hiring experienced, GCP trained staff can be difficult. Malaysia, Thailand, and the Philippines represent the best option for most indications, but Vietnam is also attracting some interest.
In the last few years we have seen the introduction of adaptive monitoring across the globe, the biggest change to the industry since e case report forms (eCRFs) came into play. There have been large investments in technology around Adaptive Monitoring but implementation across Asia has been challenging. While there have been enormous steps forward in improving the speed of clinical trials and the way each country embraces trials, this new way of managing them has required new solutions to ensure smooth implementation and adherence to local ethics requirements. These challenges will continue through the next few years as the industry adapts.
A key opportunity for APAC is to embrace technology at the client, site, CRO, and patient level. Everyone should be considering how technology can assist with faster drug development. Patients are consumers and we need to offer them ways to access these trials in an easier way, technology can help us to do that. In every trial we see sites which fail to recruit patients. This is a waste of time and money. There has also been a lazy approach to patient recruitment where we wait for patients to approach us to enroll in a trial. There is opportunity to use data to help with patient recruitment, retention, site selection, the ability to evaluate trends with adverse events, etc.
In the US, data is more easily accessible. In
APAC, we need to look for ways to access or utilize data such as patient claims and outcome data, social listening, internal databases, licensing, or purchase data from external sources, media outreach, study websites, educational videos/assets, mobile platforms, wearables, EDC integration, etc. This will enable us to select the best sites, proactively engage patients to participate in research, collect data in real time, and retain those subjects throughout the trial lifecycle. Along with the usual systems like clinical trial management system (CTMS)/ interactive web response system (IWRS), dashboards would provide a clear overview of study progress, review current and past recruitment rates, and training. The use of artificial intelligence/robotics would reduce tasks on staff and should be more commonplace within CROs.
Virtual trials and mobile platforms are a viable option for many trials and an opportunity in APAC to make the patient experience more rewarding. Integrated health data and analytics delivered as cloud-based solutions demonstrate a more agile, flexible and adaptive future of clinical development. CROs need to use technology to provide deep, datadriven insights to optimize global clinical studies and drug commercialization from concept to compound to cure. Virtually connecting patients who are beyond the clinical setting through Bluetooth wearables and connected home devices reduces participation burden and fosters patient engagement throughout the continuum of care, while also supporting the collection of billions of data endpoints.
The CRO industry is well positioned to thrive in the Asian market, with some positive momentum already being seen in many of the countries to welcome clinical trials. It is this diversity and complexity that creates a great opportunity for
CROs to provide subject matter expertise to sponsor companies to help guide them in successfully conducting clinical research in Asia.
VIRTUAL TRIALS AND MOBILE PLATFORMS ARE A VIABLE OPTION FOR MANY TRIALS
AND AN OPPORTUNITY IN APAC TO
MAKE THE PATIENT EXPERIENCE MORE REWARDING. INTEGRATED HEALTH DATA
AND ANALYTICS DELIVERED AS CLOUDBASED SOLUTIONS DEMONSTRATE A MORE AGILE, FLEXIBLE AND ADAPTIVE FUTURE OF CLINICAL DEVELOPMENT. CROS NEED TO USE TECHNOLOGY TO PROVIDE DEEP, DATADRIVEN INSIGHTS TO OPTIMIZE GLOBAL CLINICAL STUDIES AND DRUG COMMERCIALIZATION FROM CONCEPT TO COMPOUND TO CURE.
Maree Ward, Senior Director, APAC, PRA Health Sciences and JonathanNewton, Executive Director, EAPA, PRA Health Sciences