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Running
of
clinical
trial
QUIZZ!!!
1. What is clinical trials?
2. What is the main guideline used worldwide in clinical trials?
3. What are the 4 big steps in conducting clinical trials?
4. What are the stakeholders involved in the clinical trials?
5. What are documents involved in the clinical trials?
What is clinical trial?
• Any investigation in human subjects intended to
discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any
adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism,
and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
The terms clinical trial and clinical study are
synonymous.
• Good clinical trial conduct requires the
implementation of GCP guidelines.
• Good Clinical Practice (GCP) is an international
ethical and scientific guideline for conducting clinical
trials to ensure the protection of the human
participants and data.
Why?
http://www.researchamerica.org/advocacy-action/issues-researchamerica-advocates/bench-bedside-drug-
development-pipeline
Clinical trial phases
Why do we need clinical trial?
1. Patients
2. Communities
3. Academic institution
4. Government
5. Pharmaceutical company
Why do we need clinical trial? - Px
▪Contribute in science
▪To get a chance of a better treatment
▪To help the patients with the same disease in the future
Why do we need clinical trial? - Comm
▪To offer the chance of possible new medication for the community
of people who struggle with the disease (the quality of life (QoL) and
survival rate of the patient.
▪To support the development of new drug – patient care
▪To support the science
Why do we need clinical trial? - Acad
▪To support the development of new drug and science
▪To provide the best possible healthcare option for those who suffer
by asking them to join the trial (following up to completion of trial)
▪To provide innovations that could increase the effectiveness and
efficiency of the drug, as well as the adherence of the patients
during the course of medication
▪Financial gain
Why do we need clinical trial? - Gov
▪To support the improvement of quality of life and life expectancy of
the society by allowing the conduct of clinical trials
▪To increase the medication options to help improve the health of
the society
▪Indonesia: capacity building in clinical trial
Why do we need clinical trial? - Pharma
▪Bring new and better medicine to patients by the needs of patients
and a strong scientific understanding of disease
▪To get a highly qualified drug and g
General overview
▪Next slides are the steps involved…
▪Order? Different trials might have to adjust a little…
▪Some trials may have more/less steps as they have different
requirements…
▪This module will concentrate on the most important steps…
Preparation of clinical trial
1. IDEAS: set study questions, design, objectives, sample size calculation
2. Check on the regulations? BPOM, GCP, local regulations etc. Rest of the
world: their regulations.
3. Risk assessment: GCP rev2.0.
4. Consultations: R&D, Regulators, Potential Sponsor, Collaborators, Third
Parties, Potential Sites (perform site and investigator selection).
5. Start to develop: protocol, ICF, CRF and other related documentation
(monitoring plan, management plan, etc).
Preparation of clinical trial
6. Secure funding
7. Develop plans, processes and systems: randomisation (if needed), trial
management and monitoring, statistical analysis, AE/SAE and deviation
reporting, supplies (IP, device, etc), documentation and data management
8. Submit the essential documents to ethics, regulatory authorities, other
related parties to obtain approval
9. Secure contracts with principal investigator, hospital/other related parties
10. Register the trial: clinicaltrials.gov
11. Prepare the study initiation and recruitment: documents finalised, sent to
site, IP delivered, meeting invitations sent
Running of clinical trial