Critical evaluation of an article titled " Systematic review of basket trials, umbrella trials, and platform trials: A landscape analysis of master protocols"
Critical evaluation of an article titled " Systematic review of basket trials, umbrella trials, and platform trials: A landscape analysis of master protocols"
A document that provides an unbiased and comprehensive synthesis
of relevant studies and research.
Characteristics of a Systematic Review
Purposes of a systematic review
Protocol writing is a critical step in clinical research that involves developing a detailed plan or protocol for conducting a clinical trial. The protocol serves as a roadmap for the study, outlining the objectives, methodology, participant eligibility criteria, data collection procedures, and analysis plan. Here are key considerations when writing a protocol in clinical research:
Study Objectives and Research Questions: Clearly define the primary and secondary objectives of the study. State the research questions or hypotheses that the study aims to answer. This sets the foundation for the study design and data analysis plan.
Study Design: Describe the study design, such as randomized controlled trial (RCT), observational study, or non-inferiority trial. Specify the study phases (if applicable) and the allocation of study participants to different arms or groups. Justify the chosen design and explain how it aligns with the research objectives.
Participant Selection and Eligibility Criteria: Define the inclusion and exclusion criteria for participant selection. These criteria should be specific and relevant to the study population. Consider factors such as age, gender, medical history, disease severity, and previous treatments.
Interventions and Procedures: Describe the study interventions or treatments in detail. Specify the dosage, administration route, duration, and frequency of interventions. Document the study procedures, including data collection methods, laboratory tests, imaging techniques, and follow-up visits.
Sample Size and Power Calculation: Provide a rationale for the sample size estimation. Explain the statistical power calculation, specifying the desired effect size, significance level, and power. Justify the selected values and ensure that the sample size is sufficient to detect the intended effect or difference.
Data Collection and Management: Detail the data collection methods, including the use of case report forms (CRFs), electronic data capture (EDC) systems, or other data collection tools. Specify the variables to be collected, their measurement scales, and any scoring systems or questionnaires to be used. Describe the data management processes, data quality control procedures, and methods for ensuring data integrity.
Statistical Analysis Plan: Outline the statistical analyses that will be performed on the collected data. Describe the primary and secondary endpoints, statistical tests, and methods for handling missing data and outliers. Specify any interim analyses, subgroup analyses, or sensitivity analyses that will be conducted.
Ethical Considerations: Address ethical aspects, such as informed consent procedures, protection of participant confidentiality, and compliance with ethical guidelines and regulations. Discuss any potential risks and benefits to participants and how they will be mitigated. Outline the process for obtaining ethical approvals and reporting adverse events.
184 Deutsches Ärzteblatt International⏐⏐Dtsch Arztebl Int 2009.docxhyacinthshackley2629
184 Deutsches Ärzteblatt International⏐⏐Dtsch Arztebl Int 2009; 106(11): 184–9
M E D I C I N E
M edical research studies can be split into fivephases—planning, performance, documenta-
tion, analysis, and publication (1, 2). Aside from finan-
cial, organizational, logistical and personnel questions,
scientific study design is the most important aspect of
study planning. The significance of study design for
subsequent quality, the relability of the conclusions,
and the ability to publish a study are often underestimated
(1). Long before the volunteers are recruited, the study
design has set the points for fulfilling the study objec-
tives. In contrast to errors in the statistical evaluation,
errors in design cannot be corrected after the study has
been completed. This is why the study design must be
laid down carefully before starting and specified in the
study protocol.
The term "study design" is not used consistently in
the scientific literature. The term is often restricted to
the use of a suitable type of study. However, the term
can also mean the overall plan for all procedures in-
volved in the study. If a study is properly planned, the
factors which distort or bias the result of a test procedure
can be minimized (3, 4). We will use the term in a
comprehensive sense in the present article. This will
deal with the following six aspects of study design:
the question to be answered, the study population, the
type of study, the unit of analysis, the measuring tech-
nique, and the calculation of sample size—, on the
basis of selected articles from the international litera-
ture and our own expertise. This is intended to help
the reader to classify and evaluate the results in publi-
cations. Those who plan to perform their own studies
must occupy themselves intensively with the issue of
study design.
Question to be answered
The question to be answered by the research is of
decisive importance for study planning. The research
worker must be clear about the objectives. He must
think very carefully about the question(s) to be
answered by the study. This question must be opera-
tionalized, meaning that it must be converted into a
measurable and evaluable form. This demands an
adequate design and suitable measurement parameters.
A distinction must be made between the main questions
to be answered and secondary questions. The result of
the study should be that open questions are answered
R E V I E W A RT I C L E
Study Design in Medical Research
Part 2 of a Series on the Evaluation of Scientific Publications
Bernd Röhrig, Jean-Baptist du Prel, Maria Blettner
SUMMARY
Background: The scientific value and informativeness of
a medical study are determined to a major extent by the
study design. Errors in study design cannot be corrected
afterwards. Various aspects of study design are discussed
in this article.
Methods: Six essential considerations in the planning and
evaluation of medical research studies are presented and
discussed in the light.
openEHR Approach to Detailed Clinical Models (DCM) Development - Lessons Lear...Koray Atalag
Presented at Health Informatics New Zealand (HINZ 2017) Conference, 1-3 Nov 2017, Rotorua, New Zealand. Based on my Masters student Peter Wei's research. Authorship: Ping-Cheng Wei, Koray Atalag and Karen Day from the University of Auckland.
An introduction on how to go about a meta-analysis. Primarily designed for people with non statistical background. Heavily borrows from Cochrane Handbook of Systematic Reviews of Interventions.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
A document that provides an unbiased and comprehensive synthesis
of relevant studies and research.
Characteristics of a Systematic Review
Purposes of a systematic review
Protocol writing is a critical step in clinical research that involves developing a detailed plan or protocol for conducting a clinical trial. The protocol serves as a roadmap for the study, outlining the objectives, methodology, participant eligibility criteria, data collection procedures, and analysis plan. Here are key considerations when writing a protocol in clinical research:
Study Objectives and Research Questions: Clearly define the primary and secondary objectives of the study. State the research questions or hypotheses that the study aims to answer. This sets the foundation for the study design and data analysis plan.
Study Design: Describe the study design, such as randomized controlled trial (RCT), observational study, or non-inferiority trial. Specify the study phases (if applicable) and the allocation of study participants to different arms or groups. Justify the chosen design and explain how it aligns with the research objectives.
Participant Selection and Eligibility Criteria: Define the inclusion and exclusion criteria for participant selection. These criteria should be specific and relevant to the study population. Consider factors such as age, gender, medical history, disease severity, and previous treatments.
Interventions and Procedures: Describe the study interventions or treatments in detail. Specify the dosage, administration route, duration, and frequency of interventions. Document the study procedures, including data collection methods, laboratory tests, imaging techniques, and follow-up visits.
Sample Size and Power Calculation: Provide a rationale for the sample size estimation. Explain the statistical power calculation, specifying the desired effect size, significance level, and power. Justify the selected values and ensure that the sample size is sufficient to detect the intended effect or difference.
Data Collection and Management: Detail the data collection methods, including the use of case report forms (CRFs), electronic data capture (EDC) systems, or other data collection tools. Specify the variables to be collected, their measurement scales, and any scoring systems or questionnaires to be used. Describe the data management processes, data quality control procedures, and methods for ensuring data integrity.
Statistical Analysis Plan: Outline the statistical analyses that will be performed on the collected data. Describe the primary and secondary endpoints, statistical tests, and methods for handling missing data and outliers. Specify any interim analyses, subgroup analyses, or sensitivity analyses that will be conducted.
Ethical Considerations: Address ethical aspects, such as informed consent procedures, protection of participant confidentiality, and compliance with ethical guidelines and regulations. Discuss any potential risks and benefits to participants and how they will be mitigated. Outline the process for obtaining ethical approvals and reporting adverse events.
184 Deutsches Ärzteblatt International⏐⏐Dtsch Arztebl Int 2009.docxhyacinthshackley2629
184 Deutsches Ärzteblatt International⏐⏐Dtsch Arztebl Int 2009; 106(11): 184–9
M E D I C I N E
M edical research studies can be split into fivephases—planning, performance, documenta-
tion, analysis, and publication (1, 2). Aside from finan-
cial, organizational, logistical and personnel questions,
scientific study design is the most important aspect of
study planning. The significance of study design for
subsequent quality, the relability of the conclusions,
and the ability to publish a study are often underestimated
(1). Long before the volunteers are recruited, the study
design has set the points for fulfilling the study objec-
tives. In contrast to errors in the statistical evaluation,
errors in design cannot be corrected after the study has
been completed. This is why the study design must be
laid down carefully before starting and specified in the
study protocol.
The term "study design" is not used consistently in
the scientific literature. The term is often restricted to
the use of a suitable type of study. However, the term
can also mean the overall plan for all procedures in-
volved in the study. If a study is properly planned, the
factors which distort or bias the result of a test procedure
can be minimized (3, 4). We will use the term in a
comprehensive sense in the present article. This will
deal with the following six aspects of study design:
the question to be answered, the study population, the
type of study, the unit of analysis, the measuring tech-
nique, and the calculation of sample size—, on the
basis of selected articles from the international litera-
ture and our own expertise. This is intended to help
the reader to classify and evaluate the results in publi-
cations. Those who plan to perform their own studies
must occupy themselves intensively with the issue of
study design.
Question to be answered
The question to be answered by the research is of
decisive importance for study planning. The research
worker must be clear about the objectives. He must
think very carefully about the question(s) to be
answered by the study. This question must be opera-
tionalized, meaning that it must be converted into a
measurable and evaluable form. This demands an
adequate design and suitable measurement parameters.
A distinction must be made between the main questions
to be answered and secondary questions. The result of
the study should be that open questions are answered
R E V I E W A RT I C L E
Study Design in Medical Research
Part 2 of a Series on the Evaluation of Scientific Publications
Bernd Röhrig, Jean-Baptist du Prel, Maria Blettner
SUMMARY
Background: The scientific value and informativeness of
a medical study are determined to a major extent by the
study design. Errors in study design cannot be corrected
afterwards. Various aspects of study design are discussed
in this article.
Methods: Six essential considerations in the planning and
evaluation of medical research studies are presented and
discussed in the light.
openEHR Approach to Detailed Clinical Models (DCM) Development - Lessons Lear...Koray Atalag
Presented at Health Informatics New Zealand (HINZ 2017) Conference, 1-3 Nov 2017, Rotorua, New Zealand. Based on my Masters student Peter Wei's research. Authorship: Ping-Cheng Wei, Koray Atalag and Karen Day from the University of Auckland.
An introduction on how to go about a meta-analysis. Primarily designed for people with non statistical background. Heavily borrows from Cochrane Handbook of Systematic Reviews of Interventions.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
Definition of social pharmacy, social pharmacy as a discipline, scope of social pharmacy and role of pharmacist in public health, National Health Mission, National rural health mission, National urban health mission
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
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Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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Ethnobotany and Ethnopharmacology:
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Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
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In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
ESC Beyond Borders _From EU to You_ InfoPack general.pdf
Designing Protocol.pdf
1. Designing Protocol
Dr. Ramesh Bhandari
Asst. Professor
Department of Pharmacy Practice
KLE College of Pharmacy, Belagavi
KLE Academy of Higher Education and Research (KAHER)
2. DISCLAIMER
Views, thought and opinions expressed in this
presentation are my own and not necessarily with
organization I am affiliated.
3. DESIGNING PROTOCOL
An official set of procedures for what actions to
take in a certain situation.1
A document that describes the objective(s),
design, methodology, statistical considerations,
and organization of a trial.2
A written plan for a study
1 - https://www.dictionary.com/browse/protocol
2 - ICH GCP
4. DESIGNING PROTOCOL
The protocol is based
on the study design:
Systematic review/meta analysis
RCT/Non-RCT
Cohort
Case-control
Cross-sectional
Case Series
Case report / Editorial
5. DESIGNING PROTOCOL
General Components of Protocol:
➢ Title Page / Cover page
➢ Introduction
➢ Need for study
➢ Review of literature
➢ Objective(s)
➢ Methodology
➢ Timeline
➢ References
6. DESIGNING PROTOCOL
Title Page / Cover Page
Title of the study:
Population, Intervention/Exposure, Comparator,
Outcome (PICO/PECO)
Time, Type of study design, settings
Names and contact details of Investigator(s)
7. DESIGNING PROTOCOL
Introduction
➢ Definition of technical terms
➢ Acronyms written in full (first use)
➢ Introduce the topic of the research
➢ Enough detail to understand the research
8. DESIGNING PROTOCOL
ASSESSMENT OF COGNITION LEVEL AMONG EPILEPSY
PATIENT’S AND IT’S PREDICTORS: A CROSS SECTIONAL
STUDY
➢ Definition of terms (Epilepsy, cognition level, Predictors)
➢ Introduce research topic
➢ Place those terms in context with the research topic (assessment
of cognition level)
9. DESIGNING PROTOCOL
Need for Study
➢ What is already known about this topic?
➢ Define the research problem.
➢ Research question outline clearly
➢ Research question justified given what is
already known about the topic?
10. DESIGNING PROTOCOL
Need for Study
➢ Explain why the current research is essential.
➢ Logical progression from existing to current
knowledge progression
➢ What values does the paper add?
➢ Are the claims justified?
12. DESIGNING PROTOCOL
Review of literature
➢ Process of:
✓ Synthesizing what is known and what is not
known
✓ Identifying the gap
13. DESIGNING PROTOCOL
Objective(s)
➢ Purpose of the study
➢ Clearly state the objective(s)
✓ S – Specific
✓ M – Measurable
✓ A – Achievable
✓ R – Relevance
✓ T – Time-bound
14. DESIGNING PROTOCOL
Objective(s)
➢ To compare the cognition level among epileptic patients taking
anti-epileptic drugs using three different scales.
➢ To identify the predictors affecting cognition level.
➢ To correlate between the cognition level and duration of anti-
epileptic drugs
19. DESIGNING PROTOCOL
References
➢ Vancouver system
➢ Chicago style
➢ MLA (Modern Languages Association) system
➢ The APA (American Psychological Association)
system
➢ The Harvard system
➢ The MHRA (Modern Humanities Research
Association) system
20. DESIGNING PROTOCOL
Vancouver style references
➢ Journal:
Manford M. Assessment and Investigation of
Possible Epileptic Seizures. Journal of Neurology,
Neurosurgery & Psychiatry. 2001;70:ii3-ii8.
22. DESIGNING PROTOCOL
Vancouver style references
➢ Internet/websites:
Wikipedia.org. Introduction to general relativity
[Internet]. 2021 [updated 2021 May 28; cited 2021
July 13]. [9 screens]. Available from:
https://en.wikipedia.org/wiki/Introduction_to_gen
eral_relativity.
