[06.22] Good Clinical Practice Guidelines V1.pdf

Good Clinical Practice (GCP)

What is an international set of guidelines that helps make sure that the results of a clinical trial are reliable and and that the patients are protected?

Designed, Conducted, Performed, Monitored, Audited, Recorded, Analyzed, Reported

What are eight processes of a clinical trial covered by GCP guidelines?

Hippocratic Oath in 460 BC

Where did the history of GCP start?

Do no harm

What is the sum of the basic principles of the Hippocratic Oath?

1930s

When was the US Food, Drugs, and Cosmetic Act formed?

1947

When was the Nuremberg Code formed?

Adverse events in human subjects

What led to the formation of the Nuremberg Code?

1948

When was the Human Rights Declaration formed?

1964

When was the Declaration of Helsinki formed?

1979

When did we have the Belmont Report?

1982

When did the International Guidelines for Biomedical Research Involving Human Subjects start?

1996

When were the ICH-GCP guidelines issued?

1997

Since when have the ICH-GCP guidelines become laws in some countries?

Increase ethical awareness

What is one rationale for GCP related to ethics?

Improved trial methods

What is one rationale for GCP related to methodology?

Clinical trial concepts are better understood

What is one rationale for GCP related to comprehension?

For public health or for political concern over safety aspects

What is one public/political rationale for GCP?

To guard against fraud and accidents during clinical trials

What is one rationale for GCP related to integrity and safety?

Needed for growing research and development costs

What is one rationale for GCP related to finances?

Increased competition

What is one rationale for GCP related to the market?

Mutual recognition of data

What is one rationale for GCP related to international acceptance?

New market structure

What is one rationale for GCP related to commercial organization?

13

How many core principles does GCP have?

In all of its components (specific when constructing the methodology, including subject information sheet and informed consent)

When should the 13 core principles be considered in making a research proposal?

Declaration of Helsinki

Where do the ethical principles for clinical trials, as mandated by GCP, have their origin?

Applicable regulatory requirements

What must ethical principles in clinical trials be consistent with, besides GCP and the Declaration of Helsinki?

Each institution has its own ethical guidelines

What must follow the core principles of GCP in terms of ethics?

Foreseeable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society

What must be done before a trial is initiated?

Vulnerable groups (Women, Children, Other vulnerable populations)

What specific populations require special consideration when weighing risks and benefits?

PWD, HIV patients, cancer patients, children with autism

What are four examples of special vulnerable groups listed?

Safeguard benefits

What needs to be provided for vulnerable subjects in clinical trials?

How will this be managed?

What must be addressed if a patient gets an adverse event?

How will this be handled?

What must be addressed if death occurs in a clinical subject?

Psychological or psychiatric help

What needs to be provided by the investigators if mental health issues are encountered?

Only if the anticipated benefits justify the risks

Under what condition should a trial be initiated and continued?

Stage IV patients

What specific population is used as an example for calculating perceived benefit in a new cancer drug trial?

Docetaxel

What is the standard of care for non-small cell carcinoma in Case #1?

Gefitinib

What new drug is being tested against the standard of care in Case #1?

EGFR copy and the ease of the administration of the drug

What two anticipated benefits does Gefitinib offer over Docetaxel in the example?

Orally administered

How is gefitinib administered?

Intravenously administered

How is docetaxel administered?

The rights, safety, and well-being of the trial subjects

What are the most important considerations in a trial?

Prevail over the interest of science and society

What should the rights, safety, and well-being of trial subjects do?

Children with autism

What specific hard-to-reach population needs their caregivers considered?

PWDs, Patients with HIV

What two other vulnerable groups besides children with autism are mentioned as hard to reach?

Intravenous drug users, Women and children, Sex workers

What three specific groups are listed as vulnerable to HIV?

Intravenous drug use is considered a crime in the Philippines

What is the legal challenge regarding HIV-Positive Intravenous Drug Users (Case #2)?

Need to keep this information confidential

What must be done with the information of HIV-positive intravenous drug users who will not harm others?

Provide safeguards for them

What is in our best interest for vulnerable groups?

Non-clinical and clinical information

What available data on an investigational product should be adequate to support the proposed clinical trial?

Clinical trials

In what type of research is GCP mostly seen?

Chemical components

What information must be available for the drug being investigated?

Scientifically sound, described clearly, and have a detailed protocol

What three characteristics must good quality clinical trials have?

Refine and connect everything

What do preceptorial sessions help do with the research proposal?

Backbone of any study

What is a detailed protocol that is clear and of good quality considered?

In compliance with the protocol

How should a trial be conducted?

IRB or independent ethics committee (IEC) approval/favourable opinion

What must the protocol have received prior to the trial?

Research defense

What event precedes the submission of the final proposal to UREO in RMT 2 practice?

University Research Ethics Office (UREO) of the Ateneo

Where is the final proposal submitted after the research defense?

Undergo another IRB clearance

What may be required if the study site is in other organizations (e.g., tertiary hospitals)?

PHREB (Philippines Health Research Ethics Board)

What is the centralized ethics clearance of the DOH?

All studies that work with the DOH

What must undergo PHREB clearance?

Need to be stopped

What must happen to any deviation from the protocol while the study is being conducted?

Submit an amendment to the ethical review board

What must be done if modifications in methodology are needed?

Only once the amendment is approved by the ethics committee

When can the study proceed after protocol modification?

Qualified physician or, when appropriate, of a qualified dentist

Who is responsible for the medical care and medical decisions on behalf of subjects?

Consider all adverse events

What needs to be accounted for in any decisions made for the subjects in a clinical trial?

Manage the adverse events or anticipate these

What should a physician be able to do, even if not necessarily the investigator?

Qualified by education, training, and experience

What must each individual involved in conducting a trial be?

Prior to initiation of the pilot testing of any drug

When are staff development and separate training part of the preparation?

Freely given and obtained from every subject prior to any clinical trial participation

How must informed consent be obtained?

Subject information sheet

What should an informed consent form include?

Very detailed information of the study

What does the subject information sheet contain?

Voluntary and the participant can withdraw freely at any point in time

What must be emphasized about participation in the clinical trial?

Recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification

How should clinical trial information be managed?

Data management

In what area are the basic principles taught that cover safeguarding against information and collection bias?

Construction of a very good study tool

On what does the accuracy, validity, and reliability of clinical trial data depend?

Verified and validated

What must any trial tool used be?

Protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)

How should the confidentiality of records that could identify subjects be managed?

By not getting or not entering their personal information

How is the confidentiality of child participants usually ensured in most clinical trials?

Dissemination of information

What process is included in confidentiality guidelines?

Eyes and other identifying marks on the face must be covered

What must be covered in photographs of patients?

Cover the patient’s personal information

What must be done when posting pathological slides or X-rays?

Good Manufacturing Practice (GMP)

What must investigational manufactured products be handled and stored in accordance with?

Handling and logistics of the medications

What does Good Manufacturing Practice refer to?

Maintaining temperature in the cold chain for vaccines and other medications

What is an example of GMP compliance for handling medications?

Approved protocol

What must investigational products be used in accordance with?

Quality Assurance

What refers to systems with procedures that assure the quality of every aspect of the trial?

First, to do no harm

What is the dictum of medicine to always remember?

Each student will need to undergo their own GCP certification

What is required of the students for UREO purposes?

National Institute on Drug Abuse (NIDA) GCP Training site

What specific free site is recommended for GCP certification?

Good standard and accepted by the University Research Ethics Office (UREO)

What is the quality of the NIDA GCP Training site?

Up to 3 years

How long may a GCP certification last in some cases?

Individual task

What kind of task is the GCP certification required for students in RMT 2?

Submission to the Ateneo Ethics Board in the 2nd semester

When will the GCP certification be required?

Reliable and that the patients are protected

What two outcomes do GCP Guidelines ensure for clinical trial results?

Design stage until the reporting stage

What process does GCP cover regarding clinical trials?

Ethical code of the institution it operates in, as well as the Declaration of Helsinki

What must clinical trials be conducted in accordance with?

Trial participants

Whose rights, safety, and well-being must always take precedence over scientific interests?

Confidentiality for stigmatized groups like drug users

What is a critical safeguard for vulnerable populations?