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Clinical Study Start-uP

The document outlines the key activities required for starting up a clinical study, including developing contracts and agreements, clinical study protocols, informed consent documents, FDA registration, and site initiation visits. It discusses the elements that should be included in clinical study protocols such as the study objectives, design, inclusion/exclusion criteria, safety reporting procedures, and quality control measures. It also covers obtaining necessary ethics approvals, registering with regulatory agencies, obtaining informed consent, and addressing contingencies for early study termination. The overall purpose is to ensure clinical studies are conducted properly according to regulatory standards to minimize errors and variability in study conduct.

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Mary Angelique Banogon
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173 views5 pages

Clinical Study Start-uP

The document outlines the key activities required for starting up a clinical study, including developing contracts and agreements, clinical study protocols, informed consent documents, FDA registration, and site initiation visits. It discusses the elements that should be included in clinical study protocols such as the study objectives, design, inclusion/exclusion criteria, safety reporting procedures, and quality control measures. It also covers obtaining necessary ethics approvals, registering with regulatory agencies, obtaining informed consent, and addressing contingencies for early study termination. The overall purpose is to ensure clinical studies are conducted properly according to regulatory standards to minimize errors and variability in study conduct.

Uploaded by

Mary Angelique Banogon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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CEBU DOCTORS’ UNIVERSITY

GRADUATE SCHOOL
Master Of Science In Pharmacy

Clinical Study Start-Up Activities


Presented by: Mary Angelique C. Banogon, RPh
Outline:
• Contracts and Agreements
• Clinical Study Protocols
– Elements
• Informed consent
– Types
– Elements
• FDA Registration
• Site Initiation Visit

Contracts and Agreements


• The Contract Service Agreement (CSA) is a common instrument that identifies not only the
tasks and activities with the corresponding budgets and timeframes, it also enumerates the
responsibilities and milestones agreed upon by the parties concerned often the study sponsor
and the CRO.

Clinical Study Protocol


• What is it?
– A “cookbook” or a set of instructions as to how the clinical study will be conducted
• Who can enroll in the study? (inclusion/exclusion criteria)
• What procedures will be performed before, during and after the study?
• How will the data be collected and analyzed?
• Why do you have one?
– To minimize error (or protocol deviations) over the course of the study
– To ensure consistency in study activities and study conduct
• Key Elements of a Protocol • Trial procedures (screening, trial
• Background and rationale period, follow-up, assessments)
• Study objectives • Adverse event reporting
• Experimental design and methods • Trial medication
• Schedule of assessments • Premature withdrawal
• Subject selection criteria • Subject replacement policy
CEBU DOCTORS’ UNIVERSITY
GRADUATE SCHOOL
Master Of Science In Pharmacy
• Criteria for excluding data • Ethics (e.g. IRB/IEC approval)
• Data analysis/statistical methods • Definition of end of trial
• Quality control/assurance • Sponsor discontinuation criteria
• Data handling and record keeping • Signatures

Background or Target Rationale


• Past Literature
• Summary of Pre-Clinical Data
• Unmet medical need
Identify objectives
• Every protocol must state a primary, quantifiable study objective. Secondary objectives should
be limited in scope and related to the primary question.
• Objectives must be specific and capable of answering a key clinical question required by the
Clinical Development Plans
• Objectives will vary if it is a Phase I, II, III, or IV clinical study
Study Design
• an important element in assessment of quality protocols. The overall purpose of the study
design is to reduce the variability or bias inherent in all research. A Good study design will
always address control methods that reduce experimental bias.
–
Types of Study Design
– Randomization
• the process by which two or more alternative treatments are assigned to
volunteers by chance rather than by choice.
– Placebo control
• A placebo is a pill or liquid that looks like the new treatment but does not have
any treatment value from active ingredients.
– Blinding
• Single- or double-blind studies (also called single- or double-masked studies) are
studies in which the participants do not know which medicine is being used, so
they can describe what happens without bias.
– Study Design
– Single or Multiple Dose
– Single or Multi-centered clinical site
CEBU DOCTORS’ UNIVERSITY
GRADUATE SCHOOL
Master Of Science In Pharmacy
Schedule of Assessments
• describes a schedule of time and events and provides a complete profile of the overall trial
design.
• Include acceptable time windows around the variables being collected that can minimize
protocol deviations.
Inclusion/ Exclusion Criteria
• Purpose:
– To clearly define the sample population (e.g. Healthy subjects or Patients)
– To minimize inter-subject variability
• Will need to design I/E criteria around the known mechanism of action of action, side effect
profile, and potential for drug-drug interactions
Adverse Event Reporting
• How adverse events are managed and recorded are particularly important to the sponsor and
to regulatory authorities.
• Protocol authors should ensure that the study defines the criteria for success or failure of
treatment. End points should be clear and defined.
Trial Medications
• Protocols must include clear directions for dosing intervals and adjustments.
• In addition, good protocols always include adequate compliance checks of drug consumption
by the subjects of the study.
Premature withdrawal and Subject Replacement Policy
• The means by which subjects are replaced can adversely affect the statistical analysis.
• Similarly, a decision concerning the conditions under which a subject would not be evaluable
must be stated explicitly before the study starts.
• This is intended to minimize intentional or unintentional data manipulation.
Quality Control/ Assurance
• Addresses the sponsor’s conduct of periodic monitoring visits to ensure that the protocol and
GCPs are being followed.
• The Data Handling and Record Retention section of the protocol will address the requirement
to maintain data (whether on a paper Case Report Form (CRF) or using an electronic data
collection tool (DCT) of each trial subject.
• The sponsor’s representatives or Clinical Research Associates; CRAs will monitor or review
source documents to confirm that the data recorded on CRFs are accurate – this is a
fundamental requirement of quality clinical research.
Data Handling and Record Retention
CEBU DOCTORS’ UNIVERSITY
GRADUATE SCHOOL
Master Of Science In Pharmacy
• addresses the requirement to maintain data (whether on a paper CRF or using an electronic
data collection tool (DCT) of each trial subject.
• addresses the requirements for retention of records at the trial site in accordance with
relevant guidelines and regulatory requirements.
Ethics
• deals with the fundamental requirement for prospective Institutional Review
Boards/Independent Ethics Committees (IRB/IEC) approval of the trial protocol, protocol
amendments, informed consent forms and other relevant documents.
• also detail the requirements for obtaining informed consent from trial subjects

FDA Registration
• The PFDA is currently in partnership with ERBs accredited by PHREB (Philippine Health
Research Ethics Board) to conduct technical and ethics review of the study protocol
Below is a partial list of Ethics Review Boards (or ERCs) accredited by PHREB:
1. Philippine Heart Center Ethics Review Committee
2. University of the Philippines Manila Research Ethics Board (UPMREB)
3. St. Luke’s Medical Center Institutional Review Board
4. The Medical City Institutional Review Board
5. Manila Doctors Hospital Institutional Review Board
6. Veterans Memorial Medical Center Institutional Review Board
7. Makati Medical Center Institutional Review Board
8. Davao Doctors Hospital Institutional Ethics Review Board
9. Mariano Marcos Memorial Hospital and Medical Center
10. Chong Hua Hospital Institutional Review Board
11. Baguio General Hospital and Medical Center Ethics Review Committee
12. National Kidney and Transplant Institute Research Ethics Committee
13. Lung Center of the Philippines Ethics Review Committee
14. Far Eastern University-Nicanor Reyes Memorial Foundation Institutional Ethics Review Committee
15. University of the East Ramon Magsaysay Memorial Medical Center, Inc. Research Institute for Health
Sciences Ethics Review Committee

Informed Consent
• Written Informed Consent
• Unwritten Informed Consent
CEBU DOCTORS’ UNIVERSITY
GRADUATE SCHOOL
Master Of Science In Pharmacy
• Surrogate Informed Consent
3 KEY ELEMENTS of Informed Consent:
1. Voluntary Consent
2. Information Disclosure
3. Decision-making capacity
Sponsor Discontinuation
• The section of the protocol provides a reminder to the investigator that the trial may be
terminated prematurely as a result of a regulatory authority decision, a change in opinion of
the IRB/IEC, drug safety problems or at the discretion of the sponsor.
Site Initiation Visit
• The SIV allows for all involved in the study to ask questions regarding the study protocol. In this
meeting, it is assumed however that all concerned (especially the Principal Investigator or PI)
have already read and understood the study protocol. .

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