Preclinical and Clinical Trial Requirements
Preclinical and clinical trial requirements in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals of conducting such preclinical and clinical trials.
2. How are clinical trials funded?
Clinical Trials are funded in accordance with the financial support of the subordinate bodies or its own financial resources.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Concerning the preclinical requirements: Decree No. 734 of the year 2016 stipulated the Good Clinical Practicing (GCP), which provides that the sponsor who might be a pharmaceutical company or an individual initiate, funds and organizes the conduct of the protocol. If the sponsor is a foreign company or organization then it must have a local representative to fulfill the local responsibilities. The sponsor and the investigator might be severally or jointly responsible in obtaining all the required approvals and authorizations.
Moreover, the sponsor must provide an insurance for the trial subjects to cover trial-related injury or death and provide indemnity for the investigator, except for the claims resulting from a malpractice or negligence made by the investigators’ side.
National Organization for Drug Control & Research decides to issue an approval or rejection of the clinical trial in case of the acceptance to begin on the clinical trial the aforementioned Authority sends its decision to each of the following as per Article 3 of Decree No.189 of the year 2010:
- Scientific Research Ethics Committee;
- The basic researcher who will perform the clinical trial; and
- The Central Administration of Pharmaceutical Affairs.
Concerning the trial’s requirements: The GCP provides that the trial must be concluded in accordance with the protocol concluded between the sponsor and the investigator. The trial protocol and any amendments to it, must be approved by the Institutional Review Board of the Independent Ethics Committee before any implementation occurs. Moreover, all and any consent must be pre-obtained even if new information becomes available, if relevant to the subject of the consent.
4. What are the requirements for consent by participants in clinical trials?
Information Pamphlets of the participants and their informed consent of the participants of the clinical trial. Such consent must include the following information as per the consent template provided by the Central Directorate for Research and Health Development:
- Pamphlet Approval;
- Subject of the research;
- Brief of the study;
- Main researcher;
- Participant researchers;
- Source of funds;
- Information about the disease and the research;
- Side effects;
- Possibility of approving or rejecting the participation;
- Persons who have knowledge of such research;
- Other alternatives;
- Any other inquiries;
- Acknowledgment of all the above by the participant with his signature.
Moreover, such consent must comply the GCP and the ethical principles originated from the Declaration of Helsinki developed by the World Medical Association. Prior to the conclusion of the trial, the investigator must obtain the approval of the Independent Ethics Committee with regards to the trial and any other related subject or information.
The consent by the participants must be updated, if there is any new available information that is of relevance to the subject or the trial, which as well must be approved by the Independent Ethics Committee.
5. May participants in clinical trials be compensated?
Yes, the participants of the clinical trials are secured with payable insurance and will be compensated in the occurrence of any harm or side effect due to the clinical trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The National Organization for Drug Control & Research is imposed to inspect on the place where the clinical trial will take place on and that’s to ensure that it matches the Good Clinical Practice (GCP) and reviews the documents and the attached registrations and all the relevant sources that are related to the clinical trial and to protect the rights of the participants and to ensure that the clinical trial proceeds as follows:
- The protocol that is applied for the clinical trial;
- The scientific references that are internationally recognized; and
- Standard operating procedures for clinical practice.
In case of the occurrence of lack of conformity, the aforementioned authority will classify it and will take the appropriate measures and the sort of the classification in accordance to the following:
1) Major non-compliance situations:
Trials that may possibly cause damages to the participants rights which provides the non-efficiency and non-accuracy of the information which is related to the clinical trial in this case the trial will be suspended until the proper solution to correct the situation is taken especially if there is any danger facing the participants’ life.
2) Minor non-compliance situations:
Trials, which does not cause any damages to the participants’ rights and safety and does not affect the proficiency and accuracy of the information and in this case the authority may suspend the trial or resume it.
In case the occurrence of any dangerous side effects on the participants of the clinical trial, the participant shall inform the National Organization for Drug Control & Research authority and the Scientific Research Ethics Committee within 24 hours from the occurrence of the side effects, and then will begin the analysis of the cause of the side effects and the trial will be suspended until the final results of the analysis appears if it appears that the causes of the side effects is not due to the Clinical Trial then the Trial will resume in case the trial is suspended the sponsor shall inform the authority with an explanation of the causes that led to such a suspension.
The authority shall make sure that the sponsor took all the necessary measures to ensure on the participants safety and insurance in case of the occurrence of any danger that may happen to the participants through the clinical trial.