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Clinical Trial

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Julaiha Batcha

on 31 January 2013

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Transcript of Clinical Trial

A Guide to Your Rights Clinical Trials So What is Clinical Trial in the First Place? How does it work? Who governs the clinical trials in Singapore? A research study where volunteers receive investigational treatments under the supervision of a doctor and other research professionals.

These treatments are developed by pharmaceutical companies who select
qualified physicians/ investigators, to
conduct the trials to find out the benefits
of these drugs.

Clinical trials are usually conducted in
four phases (I, II, III,IV). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers, like you. Is it safe and can anyone join in? All clinical trials are based on pre-clinical data and are screened for any side effects before introducing to participants

All trials are stringently monitored closely even after completion of the clinical trials

All clinical trials have guidelines about who can participate.

Before joining a clinical trial, a volunteer must be qualified for the study.

There would be inclusion and exclusion criteria for eligible volunteers to participate in the trial. In a clinical trial, a volunteer is usually assigned a specific study group.

Volunteers in one study group may receive study drug while other volunteers may receive a placebo or a treatment already available.

The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment.

Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study.

Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same What is GCP? 2nd Checkpoint Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for
life-threatening and chronic diseases.

Possible benefits include:

Being able to play an active role in your own healthcare.

Being able to gain access to new research
treatments before they are widely available.

Being able to help others through medical research. Benefits of joining a trial Possible risks include:

experiencing unpleasant side effects from new drugs or procedures.

taking drugs or undergoing procedures that may be less effective than those currently available.

you will require more time and attention than a non-protocol treatment,including trips to the study site, more treatments, hospital stays, or complex dosage requirements. Please note: Volunteers may withdraw from a study at any time for any reason. Risks Involved Clinical Trial Myths..... a) MYTH:
Patients in cancer clinical trials are treated like guinea pigs.

b) MYTH:
Clinical trial patients are given sugar pills.

c) MYTH:
Informed consent is meant primarily to protect the legal interests of researchers.

d) MYTH:
Clinical trials are only a last resort for people who have exhausted all other treatments.

e) MYTH:
Once you sign up for a trial, you're stuck. You can't get out of it.

f) MYTH:
Clinical trials are just not safe. They are too risky.
Three main legislations that provide the current formal regulatory framework:
Medicines Act 1975
Medicines (Clinical Trials) Regulations 1978
Singapore Guidelines for Good Clinical Practice (SGGCP) 1998

Rationale for clinical trial regulation:

Protect safety and interests of volunteers of the trial

Prevent clinical trials that are unethical, unscientific, or have unacceptable risks. Good Clinical Practice is the ethical, scientific and regulatory standards for conducting research involving human subjects.

Essential Elements

a) Participant’s rights, safety well being and confidentiality

b) Data Integrity Foundation of GCP a) Nuremberg Code The foundation of GCP is based on 4 key milestones outlined previously from past disasters in clinical trials that violated the rights, safety and well being of research participants. b) Declaration of Helsinki c) Belmont Report d) ICH Guidelines Conformity to the Ethical Principles in a Clinical Trial
(a Multilevel Checkpoint Compliance by the Different Players Involved) 1st checkpoint: Health Sciences Authority (HSA) HSA is a statutory licensing board under Ministry of Health (MOH).

Before conducting a clinical trial, a clinical trial certificate (CTC) has to be issued by the HSA (1). (1) Health Sciences Authority, Guideline on Application for Clinical Trial Certificate (CTC), Singapore. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/ctc_application.html How HSA approves
clinical trial? As the national Regulatory Authority for drugs, health products and medical devices, HSA approves a clinical trial on:
(i) the scientific merit of research proposals and
(ii) ethical aspects of the trial i.e. protection of human participants (2). HSA consults its own advisory committee, the Medical Clinical Research Committee (MCRC), on decisions of approving a trial. A parallel submission to the institutions’ or hospital ethics’ committee (IRB) is also required.

Clinical trials therefore undergo two separate ethics review one by the respective IRB and another by MCRC (2).

HSA has indicated that clinical trials should only begin when both regulatory and ethics approvals have been obtained (1). (1) Health Sciences Authority, Guideline on Application for Clinical Trial Certificate (CTC), Singapore. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/ctc_application.html
(2) Bioethics in Singapore: The Ethical Microcosm by John Elliott, W. Calvin Ho, Sylvia S. N. Lim. 2010. p39. Why HSA inspects clinical trial? HSA also conducts audits and GCP compliance inspection to the clinical trial sites to ensure (3):

(i) Safeguard the rights, safety and well-being of trial subjects.

(ii) To verify the quality and integrity of the clinical trial data submitted to
the Regulatory Authorities.

(iii) To assess compliance to the protocol, applicable regulations, guidelines
and standard operating procedures for clinical trials. (3) Guideline on GCP Compliance Inspection Framework. http://www.hsa.gov.sg/publish/hsaportal/en
/health_products_regulation/clinical_trials/guidelines/gcp_compliance_inspection Medical Clinical Research Committee (MCRC) The MCRC’s responsibility is to safeguard the rights and welfare of human participants in clinical trial (4).

Being the advisory body to HSA, it is responsible for reviewing applications for drug trials and provides advice on the licensing of clinical drug trials.

MCRC ensures that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded (Declaration of Helsinki & SG-GCP).

The MCRC also continuously review the clinical trial and monitors serious side effects (adverse events)
in the course of the trial (4). (4) Bioethics Advisory Committee, Singapore, Research Involving Human Subjects: Guidelines for IRBs, November2004, pp. 10-11, para 2.11 EC (Ethics Committee)
IEC (Independent Ethics Committee)
IRB (Institutional Review Board)
HREC (Human Research Ethics Committee) Independent body Part of an institution or commercial entities

Serve as “central” IRBs, ex.

NHG Domain Specific Review Board (DSRB)

Singhealth Centralised Institutional Review Board (CIRB) How could the IRBs be an independent body? Consist of at least 5 members:

At least one scientist

At least one who is from non-scientific area

At least one who is independent of the institution Before Initiating a clinical trial Risks to participants are minimized

Risks are reasonable in relation to anticipated benefits – if any

Selection of participants is equitable

Informed consent will be sought & appropriately documented

Adequate provisions to protect the privacy of subjects & to maintain the confidentiality of data

Special attention will be paid to trials that may include vulnerable participants.

Consider qualification of the investigator for the trial.

Review both the amount and method of payment to participants. During a Clinical Trial Conduct continuing review of ongoing trial

SGGCP guidelines

Evaluate the safety

No deviation from, or changes of the protocol be initiated without prior written IRB approval except when necessary to eliminate immediate hazards to participants.

AE, SAE may cause IRB to require changes to the study, suspend or withdraw the study completely. 3rd Checkpoint Sponsor

(Data Safety Monitoring Boards) Apply for CTC from HSA before any clinical trial initiation.
Implementing & maintaining QA & QC with written SOP.
Compensate trial patients in the event of all trial-related injuries. Ensure study conducted according to protocol and GCP.
Ensure compliance with regulations.
Ensure adverse events reported according to the regulations, revision to the consent and protocol be considered.
Monitor data for safety and efficacy. (DSMB) Ensure fair compensation to participants. Compensation to Participants Guidelines
International Ethical Guidelines for Biomedical Research Involving Human Subjects, the Council for International Organisation of Medical Sciences (CIOMS)
-- 2002 revised draft
Guideline 19: Rights of injured subjects treatment and compensation. Free medical treatment for research induced injury.

Financially compensate subjects equitably for any resultant impairment, disability or handicap.

In the case of death as a result of their participation, their dependents are entitled to compensation.

Subjects must not be asked to waive the right to compensation. 4th Checkpoint – Study Team PI: Principal Investigator (specialist consultant, senior consultant, dentist, etc)

Co-I: Co-Investigator

CRC: Clinical Research Coordinator

Others: Study nurse, pharmacist, etc What are the measures to ensure your rights, safety and well-being? Qualifications and Agreements

The principal investigator is qualified to conduct the study.

The study protocol is approved with scientifically sound study design and favorable risk-benefit ratio.

The study team possesses sound knowledge on the study drug.

Any conflict of interest are disclosed by the investigators.
There are adequate number of qualified staff and facilities in the study site.

Adequate medical care is provided for any adverse events.

Adverse event are closely monitored and timely reported. Adequate Resources and Medical Care of Participants The principal investigator and members of study team are strictly compliant with the approved protocol and SGGCP

Any deviation from protocol is submitted to EC and MCRC for approval

There will be frequent monitoring and auditing of study progress by the sponsor, EC and MCRC

Personal information of participants will not be revealed and will be kept strictly confidential at all times

Thorough inform consent process is conducted in proper manner Compliance and Audit Informed Consent 1) When should a inform consent be done?

Strictly before any procedure is performed

2) Essential elements of a proper inform consent process? What you should know as a participant? Participants should be fully aware of the risks involving a trial and the procedures they need to go through

Participants should know that

alternative treatment exists and participation is voluntary

there should be no coercion and undue influence

they can withdraw at any point of time during the trial A re-consent is needed when new information of the trial is made available and choose to discontinue

Participants should report any side effects experienced to the study team

Sign the dotted line only after all doubts clarified Example of a Clinical Trial involving Menopausal Women Paroxetine controlled release in the treatment of symptomatic menopausal women following discontinuation of hormone therapy 64 enrolled based on inclusion/exclusion criteria Randomized 1:1 ratio to paroxetine CR or placebo Double-blinded Outcome measures include daily hot flash frequency and severity Treatment shown to be efficacious for menopause-related vasomotor symptoms Questions to discuss with the trial team What is the aim of this study?

Why do researchers believe that the experimental treatment being tested may be valuable?

How might this trial affect my daily life?

Will my participation worsen my health condition?

Will there be any side effects?

Who will pay for the experimental treatment?

Will I be covered if I am hospitalized due to the experimental treatment?

Will there be any reimbursement for other expenses?

Will I continue to be provided with the experimental drugs after the trial is completed? Conclusion Who assists HSA? Reg5, (3)

A certificate may be issued subject to such terms and conditions as the licensing authority may think fit to impose, including any condition requiring the sponsor of a clinical trial to obtain and maintain insurance to provide compensation in the event of injury or loss arising from the conduct of the trial on such terms as the licensing authority may approve. Singapore Law
regarding compensation
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