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Following is a question by Dr Hon Pan Pey-chyou and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (December 15):
Question:
Pursuant to section 36B of the Pharmacy and Poisons Regulations (Cap. 138 sub. leg. A) (the Regulations), for the purpose of conducting a clinical trial on human beings or a medicinal test on animals, application shall be made in writing to the committee under the Pharmacy and Poisons Board (the Board). It has been reported that the Hospital Authority (HA) is currently conducting a clinical trial on the use of Avastin beyond its licensed indication (off-label use), but it has not applied for or obtained a certificate from the Board in accordance with the Regulations. In this connection, will the Government inform this Council:
(a) whether it knows for how long the clinical trial on the off-label use of Avastin has been conducted, and the total number of patients who have undergone the trial;
(b) whether it knows the reasons why HA has conducted the aforesaid clinical trial before obtaining the certificate issued by the Board;
(c) how the authorities will deal with the situation where a clinical trial is found to have been conducted without applying for or before obtaining a certificate as required by the Regulations; whether the authorities will immediately prohibit such a trial from continuing; if they will not, of the reasons for that;
(d) whether under the existing mechanism patients can clearly know if the certificate for the clinical trial concerned has been obtained before giving consent to undergoing the clinical trial; if they can, of the details of such mechanism; if not, the reasons for the authorities not establishing such a mechanism, and whether the authorities have conducted any assessment on how the safety of patients can be safeguarded; and
(e) of the penalty for any organisation which has been found to have breached section 36B of the Regulations; where the clinical trial of a pharmaceutical product which is conducted without obtaining the required certificate has caused serious side effects in the body of the participating patient, whether the patient concerned will be entitled to compensation; if yes, who will be responsible for paying the compensation?
Reply:
President,
(a) and (b) According to the Hospital Authority (HA), clinical trials on the off-label use of Avastin are currently conducted by the Faculty of Medicine of the universities. These clinical trials have gone through and passed independent ethical reviews to ensure their safety and scientific validity. Enquiries can be made with the universities concerned for the details of these trials.
On the other hand, HA is planning to conduct a local clinical study to compare various drug treatment options (including Avastin) for treating wet age-related macular degeneration so as to accumulate more local experience in the use of the drugs. Details of the study are under planning and the study has yet to commence.
(c) Generally speaking, a clinical trial is a medical procedure conducted with patients' knowledge and consent. It also requires approval by the Ethics Committee of the institution concerned and has to be conducted by registered healthcare professionals. If any institution is found to conduct any clinical trial without obtaining a clinical trial certificate, the Department of Health will issue a letter to the institution concerned and require it to lodge an application as soon as possible.
(d) Patient safety is the primary concern of public hospitals in the provision of all their services, including clinical studies. HA has put in place stringent guidelines and protocols for the conduct of clinical studies. All clinical studies must go through and pass independent ethical reviews to ensure their safety and scientific validity.
The scope of an ethical review mainly covers the theoretical basis of the clinical study, patient safety and information pertinent to the "Participant's Consent". The entire design of a clinical study must be target-oriented and it is necessary to ensure that the potential risks borne by the participants are kept to the minimum within the known extent of the risks. The design of the clinical study must also comply with HA's patient safety guidelines and requirements and participants need to be provided with appropriate medical support throughout the study. Besides, a mechanism for notification of serious incidents should be set up for the research project.
Institutions and researchers conducting a clinical study must explain the key aspects of the study to participants in detail and obtain their informed and voluntary consent in writing. The language used in the "Participant's Consent" must be understandable and intelligible to the participants. All information relevant to the participants (including the design, scope, objectives and requirements of the research project as well as any possible discomfort or side effects that may arise in the research process and assessment of potential risks, etc.) must be included in the "Participant's Consent" so as to let the participants know the content of the research project and the potential risks. Participants have a full right to decide and make their own choice as to whether or not to participate in the clinical study. They can also withdraw from the clinical study during the research process.
In addition to the required independent ethical review as mentioned above, institutions conducting a clinical study must also comply with other relevant requirements.
(e) It is stipulated in section 36B of the Pharmacy and Poisons Regulations (Cap. 138A) that for the purpose of conducting a clinical trial, application must be made in writing to the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee. When amending the Pharmacy and Poisons Ordinance and the Pharmacy and Poisons Regulations to implement the recommendations of the Review Committee on Regulation of Pharmaceutical Products in Hong Kong, we will impose a penalty in the legislation for the conduct of any clinical trial without a certificate.
The "Participant's Consent" is an agreement between the institution conducting the clinical study and the participant. Details about such Consent are provided in the foregoing paragraphs. If a participant institutes any litigation or lodges a claim for compensation in the course of clinical study, the institution conducting the research project would need to bear the legal liability.
Ends/Wednesday, December 15, 2010
Issued at HKT 12:07
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