Registration of Clinical Trials in the Middle East, a Luxury or a Necessity?

In an attempt to increase transparency, accountability and to protect research participants, experts have recently recommended the creation of clinical trial registries. This would provide a platform to share clinical trials data, results and make publicly available the type of study and procedures (Al-Gaseer & Shideed, 2012).

According to Clinical, the purposes for registration of trials are:

Registry Purpose Group That Benefits
Fulfill ethical obligations to participants and community Patients, general public, research community
Provide information to potential participants and referring clinicians Patients, clinicians
Reduce publication bias Users of the medical literature
Help editors and others understand the context of study results Journal editors, users of the medical literature
Promote more efficient allocation of research funds Granting agencies, research community
Help institutional review boards (IRBs) determine appropriateness of a research study IRBs, ethicists

All the trials are supposed to be registered before the recruitment of the first patient (Al-Gaseer & Shideed, 2012).

In recent years, the Middle East witnessed an increase in international research specifically clinical trials.  Commentators attributed this to lack/diminished regulations on clinical trials, the availability of treatment-naïve patients, and it costs less to carry out research in the Middle East. In addition, the lack of research ethics knowledge among healthcare workers make them less accountable to transgressions.  All these reasons made it attractive for sponsors to conduct research in developing world, including the Middle East (Al-Gaseer & Shideed, 2012).

The WHO has also encouraged the registration of clinical trials, which was propagated to member states of the Eastern Mediterranean Regional Office (EMRO). Currently, there is only one registry for clinical trials in the Middle East and it is located in Iran. However, laws regulating clinical trials were issued in Syria, Jordan and the United Arab Emirates. The article by Al Gaseer & Shideed titled “Clinical Trial Registration in the Middle East: a luxury or a necessity?” discusses the importance of registering clinical trials in the region. Beside the aforementioned general advantages, registration of clinical trials gives idea to policy makers on type of research carried in host countries so as to avoid duplication of research and wasting of the already limited resources. In addition, policy makers can access the information on sponsors and the pharmaceutical companies conducting research in the region. Moreover, it allows for ethical and regulatory oversight by host countries. The authors recommended the timely posting of clinical trial results including negative results, which they stated was a “moral obligation” (Al-Gaseer & Shideed, 2012).

In the conclusion of the article, the authors recommended an issuiance of legislation to enforce the registration of all clinical trials carried out in the region. The registry could be a national one or regionally (Al-Gaseer & Shideed, 2012).

To read the article, please visit ‘Clinical trials Registration EMRO



Clinical , ‘why should I register and submit results‘, retrieved Feb, 2013

Al-Gaseer & Shideed (2012) Registration of Clinical Trials in the ME, a Luxury or a Necessity? Eastern Mediterranean Health Journal, vol. 18 no. 2



No comments yet.

Leave a Reply

Designed & Developed by Web Ideations