4 Reasons Why Asia Isn’t Already a Clinical Trials Hub

Add bookmark

Bryan Camoens

Dr. Benjamin Co, Medical Director for Otsuka Philippines, explains the globalisation of clinical trials to Pharma IQ's Bryan Camoens. He also touches on the inconsistent research and regulation in many Asian countries and gives his take on why the cost of maintaining ethically viable studies are far less expensive in the Asian region than it is in developed worlds.

Pharma IQ: Could you please outline the current development in early clinical trials globally?

B Co: The globalisation of clinical trials has followed the path of least resistance - which means that financial impact on developed or industrialised countries has made pharmaceutical companies look at foreign sites where clinical trials can be done both efficiently and at lower costs.

Foreign sites have grown exponentially over the past decade mainly because of accessibility of human subjects, new market potentials for approved drugs and international agreements for the U.S. FDA in accepting foreign research data. In parallel to this is the growing presence of contract research organisations in various parts of the world.

Phama IQ: In your opinion, what are some of the current capacity and gaps in early stage clinical trials?

B Co: Research and regulatory capacity is not adequate and consistent in all countries, even in the Asian region where there is variability in turn around time for approval of clinical trials.

The role of the IRBs in many foreign countries are wanting. They do not focus on actual goals of monitoring patient safety and are merely conduits to reviewers of protocols and looking at total budgets for clinical trials so that they know how much to charge.

Current levels of financing are not enough to support clinical development under current cost assumption and the global financial crisis has provided a large challenge to the industry to engage in expensive early phase clinical trials during these financially changing times.

Pharma IQ: When it comes to the development of early stage trials (phase 1 trials) what sort of expectation for growth is there in the next 5-10 years?

B Co: It is difficult to speculate on this as I am not a business person. At the current trend, however, it remains to be a challenging endeavor as there is a waning R&D production in most markets with the growing generic business worldwide.

Cost consciousness has become a large focus even among patients from industrialised world. Newer drugs coming into the market will need to come from pharmaceutical industries that can address a large return of investment for the product by targeting more prevalent diseases in both developing and developed worlds rather than looking at diseases that are prevalent in one region of the world alone.

The marketing impact of a drug in current development is vital to whether it is worthy to invest in expensive early phase clinical trials or not. At the current scenario, I am speculating that it may plateau in the next 5 years.

Pharma IQ: Based on your prediction on how phase 1 trials will change in the next 5-10 years, what else needs to be done and more importantly, are we ready and how will this impact clinical research in Asia?

B Co: Asia, like most parts of the developing world, is an interesting niche for conduct of clinical trials. Asia has a large population. Considering the combination of China, India and Indonesia’s population alone - Asia will definitely be a perfect site not only because of rapid recruitment (where diseases in the developed and developing world will be similar), numerous investigative sites and the low cost of clinical trials in the region.

We cannot underscore the fact that the cost of maintaining ethically viable studies are far less expensive in the Asian region than it is in developed worlds. But clinical trials do not end with recruitment of patients or the success of the study in Asia. These clinical trials should eventually revert back as investment.

The market potential therefore in this region is just as large as the clinical trial itself considering the impact of having studies done in the region and being able to sell the drug back to the same population.

But while Asia remains to be a perfect foreign site for clinical studies, there are many problems that surround or hound conducting early phase trials in Asia. Among these include:

1. Variability in regulatory approval time

2. Concern of pharmaceutical companies over countries that may have no international proprietary protection laws (or may have but do not follow the law or that the law may be in paper only)

3. Concerns with local IRBs. Sponsors have raised concerns regarding the capacity of local IRBs to adequately review research according to GCP under ICH or FDA standards.Many that sit in IRBs do not have GCP training, so how can their review the protocols?

There is also a lot of confusion among IRBs on their actual role. Because of lack of experience, many IRBs actually review protocols and dissect the procedures rather than look at patient safety which should be their role. Worse is the fact that many IRBs have this practice of looking at budgets for financial review on how much their share of the pie is. Very few IRBs actually monitor ongoing approved clinical trials in their areas and leave it to the companies to report any event that occurs in the studies.

4. Which goes to the quality of the data that comes out of the region. Rapid patient recruitment, well-trained and motivated investigators with their own clinical research teams that come out with high quality and timely clinical data has not quite picked up in the region. The high turn over rate and lack of training of the back office staff affects the quality of all clinical trials. Its largest impact is on the early phase studies where the accuracy of data is most critical. Poorly conducted phase 1 and phase 2 clinical trials are disastrous and can spell financial nightmare for companies that engage in poorly conducted early clinical trials.

[inlinead]