Preclinical and Clinical Trial Requirements
The key facts about conducting preclinical and clinical trials in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, 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?
No, there is no such express statutory requirement under Singapore legislation.
2. How are clinical trials funded?
Clinical trials may be funded by pharmaceutical companies, hospitals, medical technology companies, biotechnology companies and government agencies, among others.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Regulatory approval from the HSA as well as ethics approval from the relevant Institutional Review Board (IRB) are required prior to the conduct of any clinical trial in Singapore.
The clinical trial protocol must be clear and detailed, and describe the objectives, design, methodology, statistical considerations and organisation of a clinical trial. Protocols are also expected to comply with section 6 of the ICH E6 Good Clinical Practice Guidelines, which specify the content to be included in respect of:
- general information;
- background information;
- trial objectives and purpose;
- trial design;
- selection and withdrawal of subjects;
- treatment of subjects;
- assessment of efficacy;
- assessment of safety;
- direct access to source data/documents;
- quality control and quality assurance;
- data handling and record keeping;
- financing and insurance;
- publication policy; and
Substantial amendments to the protocol, such as a change to the sponsor or principal investigator of a clinical trial, must be submitted to the HSA for approval or acceptance of notification, whichever applicable.
4. What are the requirements for consent by participants in clinical trials?
Generally, prior consent must be obtained in respect of all subjects participating in a clinical trial. This is subject to certain exceptions. Under certain circumstances, consent is to be obtained from a person other than the subject himself, for instance, where the subject is a minor who lacks capacity or sufficient understanding and intelligence to give consent, consent must be obtained from his legal representative.
Full and reasonable explanation on certain prescribed matters must be given to the subject (or the person giving consent on his behalf), including but not limited to the following:
- the purpose of the trial;
- the treatments or procedures to be administered in the trial and the probability for random assignment of each treatment or procedure;
- the procedures to be followed in the trial, including all invasive procedures;
- the reasonably foreseeable risks or inconveniences to the subject and, where applicable, to any embryo, foetus or nursing infant;
- the reasonably expected benefits, including whether there is any intended clinical benefit to the subject;
- any alternative procedures or treatments available to the subject, and their potential benefits and risks; and
- any compensation and treatment available to the subject in the event of injury arising from participation in the trial.
Consent must be in writing and must be signed and dated by the person giving the consent.
Where the person is unable to sign or date the written form, the consent must be signed and dated in the form and manner approved by the relevant IRB and be obtained in the presence of an impartial witness. Should the person giving consent be unable to read, the written form must be read and explained to him in the presence of an impartial witness.
Legal representatives or family members giving consent on behalf of the subject must act in his best interests in accordance with the Mental Capacity Act (Chapter 177A). Relevant factors would include the subject’s past and present wishes and feelings, beliefs and values and other factors he would likely consider if he were able to do so.
5. May participants in clinical trials be compensated?
Yes, clinical trial subjects may be compensated for participating in the trial, provided that such compensation is approved by the IRB and neither presents problems of coercion nor undue influence on the trial subjects.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Clinical trial insurance is typically provided to research participants. Clinical trials conducted by the public healthcare institutions in Singapore with ethics approval are declared for insurance under the National Clinical Trial Insurance, which was initiated in 2015 by the Ministry of Health Holdings, and which harmonises the policy terms and coverage across all public healthcare institutions.