How to run clinical trials in the Middle East - Qatar
This article was originally published in Scrip
With a population of only 835,000, Qatar's GDP per capita is $103,500 and its healthcare spend represents 4.3% of GDP ($2,151 per capita in 2006).
Qatar's Supreme Council for Health is responsible for regulating clinical trials, as well as all other aspects of national health. It has set up a central research ethics committee and a plan to develop a medicines agency (mirroring to a large extent the structure of the UK's MHRA) over the next three to five years. This would not stop trials taking place in Qatar that had undergone regulatory review by an approved regulator elsewhere, such as the UK MHRA, the US FDA or the EMA. CROs will therefore have external agencies and a single internal one at their disposal.
Source: TrialTrove; Chart: Paul Wilkinson/Sneha Sowdi
The Supreme Council is actively encouraging the participation of Qatar in clinical trials. One of its main aims as it starts to build this infrastructure will be to support the work of the Qatar Sidra Foundation Biomedical Research Institute, which is being built under the guidance of Professor David Kerr CBE.
One CRO is set to start using Qatar as a site for some of its large Phase III trials run out of the Oncology Clinical Trials Office (OCTO) at the University of Oxford.
CROs generally agree that Qatar is an attractive place to carry out trials. The main reasons for this assessment are:
- the existence of an excellent centralised healthcare system;
- a qualified and available body of highly experienced individual clinicians and a burgeoning infrastructure;
- a medical school that is keen to train new doctors in the practice of running clinical trials;
- there is a stable political system;
- access to funding/Qatar's wealth;
- the Hamad Medical Corporation, which operates hospitals and has provided a well established research centre;
- an excellent place to conduct cancer trials, not only due to good facilities, but also to a high prevalence of disease (the highest in the Middle East);
- Qatar has committed 2.8% of GDP towards R&D;
- the Qatar Foundation helps co-ordinate and support R&D efforts at national and regional (GCC) levels;
- compliance with regulations is generally excellent;
- the population places great trust in its clinicians;
- ICH-GCP standards have been introduced and all trials will be open to monitoring and external audit; and
- trial results are purported to be acceptable to the EMA/FDA as they are run under the same strict regulations and the same standards apply.
The Qatar Biomedical Research Institute is another important organisation. It aims to deliver personalised medicine that can mitigate or eliminate diseases of high prevalence in Qatar and the GCC region, such as birth defects, genetic disorders, cancer and diabetes. The institute focuses on programmes of bioscience, engineering and technology research that will lead to new biomarker development, drug discovery and therapeutic vaccines. It works closely with the Sidra Medical and Research Center, Weill Cornell Medical College in Qatar and other research partners.
There are plans to build a Clinical Research Institute within the Biomedical Research Institute. This will take on the role of a "trials office" to handle and smooth out regulatory hurdles for interested pharmaceutical stakeholders.
With regard to patient recruitment, there is general agreement that there are different consent issues across the Middle East compared with the west. Consent is based more on information-giving, particularly by physicians. One CRO commented that it "is perhaps more subtle than the rigid patient-information leaflets that we have become used to in the west".
CROs and trial sponsors are looking at new ways of providing appropriate information that will be acceptable to the regulatory authorities, while remaining culturally applicable to the population.