CLINICAL STUDY REPORT
INTRODUCTION-
The content of CSRs is detailed in the ICH guideline E3. A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.
Clinical Study Reports (CSRs) are often created as part of the process of submitting applications for new medical treatments to regulators. CSRs answer questions such as: Why was the trial done? What were the important questions asked in the trial? What were the results? CSRs also include extensive details on the course of treatment for patients, the medical information collected from the patients as part of the research, and demographic data, as well as other kinds of information to explain how the trial was conducted and results were analyzed.
ICH E3 Structure & Content of clinical Study Reports-
Title Page- The title page should contain the following information:
Study title
Name of test drug/investigational product • indication studied
if not apparent from the title, a brief (1 to 2 sentences) description giving design (parallel, cross-over, blinding, randomized) comparison (placebo, active, dose/response), duration dose, and patient population • name of the sponsor
Protocol identification (code or number)
Development phase of study
Study initiation date (first patient enrolled, or any other verifiable definition) • date of early study termination, if any
Study completion date (last patient completed)
Name and affiliation of principal or coordinating investigator(s) or sponsor’s responsible medical officer
Name of company/sponsor signatory (the person responsible for the study report within the company/sponsor. The name, telephone number and fax number of the company/sponsor contact persons for questions arising during review of the study report should be indicated on this page or in the letter of application.)
Statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents
Date of the report (identify any earlier reports from the same study by title and date)
SYNOPSIS -
A brief synopsis (usually limited to 3 pages) that summarises the study should be provided The synopsis should include numerical data to illustrate results, not just text or p-values.
TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY REPORT-
The page number or other locating information of each section, including summary tables, figures and graphs
A list and the locations within the study report of appendices, tabulations and any case report forms provided.
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS -
A list of the abbreviations, and lists and definitions of specialized or unusual terms or measurements units used in the report should be provided
ETHICS
Independent Ethics Committee (IEC) or Institutional Review Board (IRB)- It should be confirmed that the study and any amendments were reviewed by an Independent Ethics Committee or Institutional Review Board
Ethical Conduct of the Study - It should be confirmed that the study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki.
Patient Information and Consent - informed consent was obtained in relation to patient enrollment
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE-
The administrative structure of the study (e.g., principal investigator, coordinating investigator, steering committee, administration, monitoring and evaluation committees, institutions, statistician, central laboratory facilities, contract research organization (C.R.O.), clinical trial supply management) should be described briefly in the body of the report.
INTRODUCTION-
The introduction should contain a brief statement (maximum: 1 page) placing the study in the context of the development of the test drug/ investigational product, relating the critical features of the study (e.g., rationale and aims, target population, treatment, duration, primary endpoints) to that development.
STUDY OBJECTIVES-
A statement describing the overall purpose(s) of the study should be provided.
INVESTIGATIONAL PLAN-
Overall Study Design and Plan
Discussion of Study Design, including the Choice of Control Groups
SELECTION OF STUDY POPULATION-
Inclusion criteria- The patient population and the selection criteria used to enter the patients into the study should be described, and the suitability of the population for the purposes of the study discussed.
Exclusion criteria- The criteria for exclusion at entry into the study should be specified and the rationale (e.g., safety concerns, administrative reasons or lack of suitability for the trial) provided.
TREATMENTS-
Treatments administered-The precise treatments or diagnostic agents to be administered in each arm of the study
Identity of investigational product- In the text of the report, a brief description of the test drugs(s)/investigational product(s) (formulation, strength, batch number(s)) should be given
EFFICACY AND SAFETY VARIABLES-
The specific efficacy and safety variables to be assessed and laboratory tests to be conducted, their schedule (days of study, time of day, relation to meals, and the timing of critical measures in relation to test drug administration, e.g., just prior to next dose, two hours after dose), the methods for measuring them, and the persons responsible for the measurements should be described
Data Quality Assurance- The quality assurance and quality control systems implemented to assure the quality of the data should be described in brief
Statistical Methods Planned in the Protocol and Determination of Sample Size- The statistical analyses planned in the protocol and any changes made before outcome results were available should be described. In this section emphasis should be on which analyses, comparisons and statistical tests were planned, not on which ones were actually used
STUDY PATIENTS-
There should be a clear accounting of all patients who entered the study, using figures or tables in the text of the report. The numbers of patients who were randomized, and who entered and completed each phase of the study, (or each week/month of the study) should be provided, as well as the reasons for all post-randomization discontinuations, grouped by treatment and by major reason (lost to follow-up, adverse event, poor compliance etc)
EFFICACY EVALUATION –
Exactly which patients were included in each efficacy analysis should be precisely defined, e.g., all patients receiving any investigational products, all patients with any efficacy observation or with a certain minimum number of observations, only patients completing the trial, all patients with an observation during a particular time window, only patients with a specified degree of compliance, etc.
SAFETY EVALUATION-
Analysis of safety-related data can be considered at three levels. First, the extent of exposure, Second, the more common adverse events, laboratory test changes, etc., Finally, serious adverse events and other significant adverse events should be identified
DISCUSSION AND OVERALL CONCLUSIONS-
The efficacy and safety results of the study and the relationship of risks and benefit should be briefly summarized and discussed, referring to the tables, figures, and sections above as needed. The presentation should not simply repeat the description of results nor introduce new results.
REFERENCES
- https://www.pfizer.com/science/clinical-trials/data-and-results/trial-results
- https://voisinconsulting.com/resources/glossary/clinical-study-report-csr
- https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-3-structure-content-clinical-study-reports-step-5_en.pdf
Student name- Nahid
Student ID- 063/042023
Qualification- Pharm.D
E-mail: nahidmuddin13@gmail.com
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