Clinical Trials: Trial Phases and design is a ppt on the different phases of the Clinical trials from Preclinical to Phase 4and the different trial designs that can be adapted to carry out the trial in humans. Preclinical phase is the phase in which trials are carried out in animals. On sucessful conduct of animal trials trials are continued in humans after filing an IND (Investigational New Drug application). The Phases in humans range from phase 1-4 besides which an additional phase called the phase 0 may be implemented in certain trials. The phase 0, also known as the microdosing phase reduces the entire duration of the trial. After Phase 3 of the trial an NDA (New Drug application) is filed to the regulatory authority, acceptance of which allows the drug to be released into the market. The phase 4 (Post Marketing surveillance) is the phase after the marketing of the drug which helps monitor adverse effects of the drug. Clinical trial dsigns are of different types based on intervention, randomisation and grouping. Few of which are case contol study, cohort study, cross sectional study and randomised contol trials. Randomised contol trials are of different types:
Parallel design: Patients are assigned and treatment is administered to two groups simultaneously: one with the investigational drug and the other with a placebo.
Crossover: Two groups are given two different treatments (A AND B) randomisation is on whether the group is given treatment A first or treatment B first, since both groups are given both the treatments.
Latin square design: 4 different treatments are given (placebo or standard) to 4 groups. The treatment are given in such a way that each patient gets each treatment atleast once.
Factorial design: 2 or more treatments are tested simultaneously such that treatment A vs control of treatment A and treatment B vs control of treatment B can be tested simultaneously.
ACRI is a leading clinical research training institute in Bangalore.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
ACRI is a leading clinical research training institute in Bangalore.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
Assignment on Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional, Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT
Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of new drug.
According to World Health Organization (WHO) clinical trial is defined as “Any research study that prospectively assigns human participants or groups of human to one or more health-related interventions to evaluate the effects on health outcome.”
This Presentation contains an introduction to clinical research.
* Basic definition of Clinical Research.
* Steps involved in clinical Research.
* Phases in Clinical Research.
* Types of clinical Trials.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
3. 3
Preclinical Research
IND Application
Phase IV
Submission of NDA
Phase III
Phase II
Phase I
Pharmacodynamic
studies in animals
Assess safety,
tolerability, PK and
PD of drug
Drug disease
interaction,
efficacy of drug
Evaluate
effectiveness and
risk- benefit ratio
Monitor long term
effects and
effectiveness
IND application requesting approval to begin
testing in humans
Formal proposal to approve new drug for sale.
In animal models
20 to 80
individuals
100-300
individuals
1000- 3000
individuals
1000+
individuals
3-6 years (3.5
approx)
1-2 years
1-2 years
2-3 years
Ongoing
following FDA
approval
5. 5
CASE CONTROL STUDY:
•Identification of subjects based on outcome status.
•Retrospective in nature.
•Comparison of frequency of exposure in a group having the disease with a group free
of the disease.
6. 6
COHORT STUDY:
•May be prospective or retrospective.
•Group of people with defined characteristics are followed up to determine
incidence of, or mortality from, some specific disease, all causes of death, or some
other outcome.
7. 7
CROSS SECTIONAL STUDY:
•To determine the prevalence without manipulating the study environment.
•Causal relationship not determined as subjects are not followed up.
8. 8
LONGITUDINAL STUDY:
•Similar to cross sectional study.
•Follow up carried for a longer duration and hence causal relation of condition
determined.
•Can be descriptive or analytical.
RANDOMISED CONTROL TRIAL:
•Participants are randomly allocated into group receiving control or treatment
drug.
•Reduces bias.
