Clinical Research Compliance

Clinical Research Compliance

The information presented within this page will provide an overview of Asian nations abilities to conduct clinical research, many of which are highly experienced in the conduct of clinical research and a few which are poised to emerge as significant sources of subject research pools within the next decade.

Referencing the “country specific” links to the right of this page will provide additional information relative to the country of interest. Also, by clicking the yellow bars in the left margin, will allow one to easily traverse this website to find country specific information relating to both clinical research and clinical laboratory activities in Asia.

Introduction
The conduct of clinical research in Asia by western based sponsors has been and continues to be an attractive alternative to conducting such research in the west. There are a number of significant reasons to focus on Asia for clinical research needs to include: the ease of subject recruitment which is driven by large treatment naive populations; fewer competing clinical trials than in the west; the ability to obtain highly trained personnel; access to lower cost infrastructure and labor pools; and the means to secure excellent data in a timely manner, all of which equate to tremendous cost savings over clinical trial conduct in the west.

There are, however, negative aspects to conducting clinical trials in Asia, of which sponsors should be aware. Concerns relate to the lax enforcement of intellectual property (IP) laws or a complete lack of IP laws in some countries. Another issue relates to the ethical treatment of subjects. Of primary concern is whether or not an Asian based Contract Research Organization (CRO) or clinical site is conducting clinical research per International Conference on Harmonization Good Clinical Practice (ICH-GCP). In some cases Asian based CROs and clinical researchers will allege to follow ICH – GCP but in reality may not have a working understanding of these regulations and in turn are unable to effectively apply the content of ICH – GCP (It should be noted that this problem also occurs in the west). The appropriate application of ICH – GCP is vital to subject safety and data integrity. For this reason it is imperative that sponsors of clinical trials thoroughly evaluate CROs and clinical research facilities by conducting clinical audits of vendors and clinical researchers prior to entering into contractual agreements (Note: such audits must be conducted by qualified independent auditors. Monitors should never be used as auditors as most lack sufficient training and experience and by virtue of their charge will introduce bias into the audit process)

Asia Countries at a Glance
There are roughly four geographic regions in Asia that are currently conducive to conduct of clinical research.

  1. Japan, South Korea and Taiwan
  2. China/Hong Kong
  3. India and Nepal
  4. Southeast Asia –
  • Mainland region – to include Cambodia, Laos, Myanmar, Thailand and Vietnam
  • Maritime region – to include Indonesia, Malaysia, Philippines and Singapore

Note: the countries described above are a representative sampling which is based upon a particular country’s level of current or anticipated public health and regulatory infrastructure development and by no means reflects the status of other Asian nations abilities to conduct quality clinical research. Information may be requested concerning other Asian nations not mentioned; please contact CliniQAl TM at Info@cliniqal.net.

One Response to “Clinical Research Compliance”

  1. dhruval doshi Says:

    i want to know about ICH-GCP GUIDELINES

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