Preclinical and Clinical Trial Requirements
All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
It is not an established requirement to conduct the clinical trials for products locally. As previously established, clinical trials are only required when the product is an innovation that is to be fresh to the market, and does not fall under the breadth of accepted references from the Ministry of Health. Every clinical trial involving a new investigational drug mandatorily needs to be registered with the MOH for drug importation procedures.
2. How are clinical trials funded?
The lion’s share of clinical research in the UAE is funded by academic grants (61%, non-sponsored studies), pharmaceutical sponsorships (28%, sponsored studies), and the remainder is secured via other vehicles, such as endowments. A clinical study agreement between the study site, investigator, CROs and the research sponsor of research is mandatory for studies that involve external sponsors. The clinical study agreement is essentially a legal document that establishes the roles and responsibility of all the study stakeholders, verified for both ethical and legal implications in the UAE. The scope, duration, risks, benefits, study budget, terms of payment, number of patient visits, data sharing, data protection, insurance and the indemnification of participants (as coverage with respect to trial-related adverse events) are elements that constitute the crux of the clinical study agreement.
Furthermore, government-run public hospitals, that are possessive of a variety of specialties, infrastructure and patients, are the major beneficiaries of sponsored research funds.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Suitability of individuals and sites involved in the conducting of the clinical trial is of paramount importance. All individuals conducting a clinical trial should have relevant professional qualifications, training and experience, in order to undertake their designated activities in compliance with Good Clinical Practice.
The clinical testing of a medicinal product should take place under the guided supervision of a physician or a doctor of dental medicine with a recognized medical specialization in the specific area, who shall be aware of the available preclinical and clinical data about the product and the study risks and procedures.
With regard to the suitability of sites involved in the clinical trial, the site of study must mandatorily have adequate resources, staffing, and facilities to conduct the proposed clinical trial.
Furthermore, regulatory and ethical approvals for a handful of products should be obtained prior to the commencement of clinical trial on humans. These include (i) medicinal products not authorized in the United Arab Emirates, and (ii) medicinal products that have been authorized in the UAE when tested for an unauthorized indication, for a pharmaceutical form other than the authorized one, in a group of patients who have not been studied thus far.
Most importantly, the criteria for the commencement of clinical trials are as follows:
- the expected therapeutic benefits for present and future trial subjects, and the benefits for health care must justify the foreseeable risks;
- the available non-clinical and clinical information on a product should be adequate enough to support the proposed clinical trial;
- the physical and mental integrity of the trial subject, his/her right to privacy and their personal data protection are guaranteed;
- insurance or compensation covering investigator or Sponsor liability has been ensured.
The researchers take into account all available Ministry of Health, federal and international guidelines and best-practices such as those published by the U.S. Food and Drug Administration, the European Medicines Agency, World Health Organization and the scientific committees attached to them when developing the documentation and when carrying out the clinical trial for a medicinal product.
4. What are the requirements for consent by participants in clinical trials?
Clinical testing of medical products should only be permitted on an individual who has been informed, in a preliminary conference with a physician, i.e., a member of the research team, of the purposes, risks and inconveniences of testing. The participant should have been informed of his right to withdraw from testing at any time, without his being penalized, and must be informed that he shall not be denied treatment as a regular patient even after the withdrawal. The participant should have personally issued consent in writing to take part, having been made aware of the nature, significance, effects and possible risks of the clinical testing.
To be able to carry out the clinical trial on a minor, written informed consent should be obtained from both parents, or from the legal guardians of said minor. The minor should be involved in the process if he or she is able to “assent” by first having the study explained to him/her, or by them reading a simple form about the study, followed by giving verbal consent on whether he/she wants to participate or not. If one of the parents are deceased or deprived of parental rights, the written informed consent should be given by the minor and by the parent exercising parental rights.
5. May participants in clinical trials be compensated?
In case of damages or death that may result from the clinical trial, the Ethics Committee shall work out the details of compensation or restitution.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
First and foremost, clinical testing on humans is carried out in a fashion that is rigidly adherent to the fundamental principles of the protection of human rights and dignity, in accordance with the Declaration of Helsinki.
The criterion for commencing the clinical trial states that the physical and mental integrity of the trial subject is of paramount importance, and guarantees his/her right to privacy and personal data protection.
Lastly, the provisional suspension guideline states that when the trial is conducted under terms other than those specified upon issuance of the authorization, or if the scientific validity of the study is suddenly discredited, or there is a risk to the safety of the subjects, or any serious concerns about the protection of rights and wellbeing of the trial subject, the trial may be provisionally suspended or terminated.