This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
Here's a list of steps on how to write a research protocol:
Write a project summary. ...
Create a section for basic information. ...
Offer the rationale for your research study. ...
State the study's goals and objectives. ...
Detail the study design. ...
Define the methodology. ...
List safety considerations. ...
Create steps for the follow-up process.
Role of protocol in clinical research.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
Guidelines to the Preparation of document.pptxShraddhaRaut43
This presentation will give you insight of the Guidelines for preparation of Clinical Document such as Protocol, Investigator Brochure and Case Report Form. This will help you to learn deeply about the Clinical documentation.
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
2. Protocol writing
It is a complete written description and scientific
rationale for a research activity involving human
subjects.
o Objectives
o Design
o Methodology
2
3. The PI must know the answers for
Is it reasonable? Do we have the resources?
What are the significant risks?
Do we have the patient population?
Associate Investigator/ outside investigators
may be included.
Should be able to write the whole CT in few
lines
3
4. Who Reads Protocols?
• The protocol language/ content should be
understood by
–Other physicians
–Nurses/CRAs
–IRB members
–Scientific reviewers
–IC for a lay person
4
5. PARTS OF THE PROTOCOL
1. TITLE PAGE
2. SIGNATURE PAGE
3. CONTENT PAGE
4. LIST OF ABBREVIATIONS
5. INTRODUCTION/ABSTRACT
6. OBJECTIVES
7. BACKGROUND/RATIONALE
8. ELIGIBILITY CRITERIA
9. STUDY DESIGN/METHODS (INCLUDING DRUG/DEVICE INFO)
10. SAFETY/ADVERSE EVENTS
11. REGULATORY GUIDANCE
12. STATISTICAL SECTION (INCLUDING ANALYSIS AND
MONITORING)
13. HUMAN SUBJECTS PROTECTION/INFORMED CONSENT 5
6. 1. TITLE PAGE
• Title page introduce the document ,its title, precise
number , sponsor and author to the reader.
• Protocol identifying number and date. Any
amendment should also bear the amendment
number and date.
• The protocol number must clearly indicate the
version number , whether it is final or draft and date
of this version.
6
7. Title page should includes :
1. Full title should include summary study design, medicinal
products ,nature of treatment (eg : treatment, prophylaxis
and diagnosis) comparator placebo , indication patient
population setting (eg : in-patient, outpatient) Randomised
double bind multiple studies.
2. Name and address of sponsor and monitor. Sponsor names
and list of responsibilities with agreed allocations
3. Name and address of the person authorised to sign the
protocol and protocol amendment for the sponsor. Generally,
chief investigator for multicentric trial or principle
investigator for single center trials.
7
8. 4. Name ,title , address and telephone number of the sponsor
medical expert for the trial
5. Name and title of the investigator who is responsible for
conducting the trial , and the address and telephone number
of the trial site.
6. Name , title , address and telephone number of the qualified
physician who is responsible for all trial site related medical
decisions.
7. Name and address of the clinical laboratory and other
medical and/or technical and/or institutions involved in the
trial.
8
9. 2. SIGNATURE PAGE
• Signature page of all healthcare professionals in the trial
including contact details of participating site, sponsor and
sponsor medical advisor if not already given above.
3. CONTENT PAGE
• This help navigation through the document by large number of
different people that will be needed throughout the life of the
trial.
9
10. 4. LIST OF ABBREVIATIONS
• All abbreviations used should be listed and defined. Accepted
international medical abbreviations should be standardised
within each project.
5. INTRODUCTION / ABSTRACT
• This summary should be only one to two pages long. It should
give the reader sufficient information to understand the
rationale for the trial , its objective and the methods that will
be used to achieve these objective.
10
11. 6. Objectives
clearly as• Objectives should be stated
hypotheses to be tested.
• Each objective should have a corresponding
discussion in the statistical section.
11
12. 7. Background and Rationale
• All protocols require a section detailing the
scientific rationale for a protocol and the
justification in medical and scientific literature
for the hypothesis being proposed.
• Introductory section should be organized in a
logical, sequential flow.
12
13. • Double check all citations
• Common mistakes
• Name misspellings (including wrong initials),
wrong journal names, wrong years of
publication, and wrong volume numbers
13
14. 8. Eligibility criteria- definition.
• Inclusion
conditions
and exclusion criteria
that must be met in
are the
order to
participate in a clinical trial.
• The most important criteria used to determine
appropriateness for clinical trial participation
include age, sex, the type and stage of a
disease, treatment history, and other medical
conditions.
14
15. Writing Eligibility Criteria for
Patient
• Eligibility criteria are the largest barrier to
clinical trials.
• There is no guideline for writing these criteria
• Poorly written or poorly conceived criteria
may affect the scientific validity of CT.
• Reasons for imposing eligibility criteria
includes scientific rationales, safety concerns,
regulatory issues, and practical considerations
15
16. The points to be considered to write
a good eligibility criteria
1. The number of eligibility criteria should be
kept to a minimum.
2. Criteria should include only those
absolutely necessary to ensure scientific
validity and patient safety.
3. Eligibility criteria should be clearly defined
and verifiable by an external auditor.
16
17. 4. Eligibility criteria should be straightforward
and unambiguous. Which of these criteria is
better understood?
1. Pregnant and/or nursing women are not
eligible.
2. All women of childbearing age are
required to have a negative serum
pregnancy test.
3. Nursing women are not eligible for this
study. All women of childbearing potential
must have a negative serum pregnancy test
within 2 weeks of study enrollment. 17
18. Failure to write eligibility criteria
properly
• Leads to
Failure to mimic clinical practice
Increased study complexity
Increased costs
Less number of patient getting recruited
18
19. 9. Study Design
• The study design section of the protocol
should contain a stepwise description of all
procedures required by the study.
• A good study design section includes sufficient
information for the participating site.
19
20. • Parts of the study design section may
include:
Initial evaluations
Screening tests
Required lab tests
Details of treatment or procedures
Device specifications
Dose scheduling and modification
Calendars
20
21. 10. Safety
• Adverse effect and side effect are terms
commonly associated with drugs. They are used
by nurses and doctors, to refer to undesirable
effects of a medication on a patient.
• The Safety (or Adverse Events) section should
include:
• Detailed information for reporting adverse events,
including reporting to the FDA and/or the sponsor
• Unblinding processes (if applicable)
• Lists of expected adverse events
21
22. 11. The Statistical Section
• The study objectives and study design
elements in the statistical section should
be described in the Objectives section
• The descriptions and definitions of
toxicities in the statistical section match
those in the Safety/AE section.
22
23. 12.Human Subjects Protection
• This section includes discussion of:
– Subject selection and exclusion
– Proposed methods of patient recruitment
– Minority representation
– Recruitment (or exclusion) of special subjects,
including vulnerable subjects
– Lists of potential risks and benefits, including
justification for risks
23
24. Informed Consent
o Disclosure of relevant information to prospective
research subjects
o Comprehension of the information provided to the
subject
o Voluntary agreement of the subject.
The protocol’s informed consent must
• Be thorough and complete
• Be written in simple, nontechnical language
• Be carefully worded to avoid complexity.
24
25. The protocol’s informed consent
must provide
• Statement that the study involves research
• Purpose of the research and the length of the
study
• Description of risks and benefits
• Discussion of alternative therapies
• Confidentiality policy
• Compensation for injury
• Contact for further questions/information
• Statement of voluntary participation
25
26. Tools for Better Writing:
Proofreading
Working too long on a protocol may habituate eyes
and brains to mistakes, simply because they’ve
been there all along.
Spell-checkers, etc.
by automatic– A document should be checked
software
– The document should be proofread.
26