This educational webcast discusses clinical trials and their role in advancing research for inflammatory bowel diseases (IBD). It provides an overview of the clinical trial process, including the different phases from pre-clinical research to FDA approval. Common features of IBD clinical trials are reviewed, such as endpoints of symptom improvement and reduction of inflammation. Resources for learning more about participating in clinical trials through organizations like CCFA and ResearchMatch are presented.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
Dr. Dylan MacKay shares his experiences in early engagement in clinical trials.
CHI's Lunchtime Learning is open to all researchers, decision-makers, clinicians, patients and members of the public who want to learn more about the theory and practice of meaningful, inclusive, and safe patient and public engagement.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
About Clinical Trials and Its Potential Benefits of ParticipatingVial Trials
Are you interested in clinical testing and want to learn about its phases and the potential benefits of participating? Then you must go through this blog right here!
The Breast International Group (BIG) is the largest international network of academic breast cancer research groups. Facilitating international clinical trials is BIG's core expertise and for that reason, we have developed a slideshare presentation to explain the basics of clinical trials.
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Clinical trials constitute a critical stage of clinical research and it is important for you to understand what clinical trials are and what forms they take. In this slide deck, we will tell you more about the types and phases of clinical trials. The idea is to help you form a basic understanding of clinical trials. This is a two-part series and the next segment will focus on the things you must remember when preparing to publish a clinical trial manuscript.
Coming soon - Part 2: Things to remember when preparing a clinical trial manuscript
FDA 2013 Clinical Investigator Training Course: The Investigator as Collabora...MedicReS
FDA 2013 Clinical Investigator Training Course: The Investigator as Collaborator in Promoting the Clinical Research Enterprise
Neil J. Weissman, M.D., MedStar Health Research Institute
SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershmanbkling
Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman
Dr. Dylan MacKay shares his experiences in early engagement in clinical trials.
CHI's Lunchtime Learning is open to all researchers, decision-makers, clinicians, patients and members of the public who want to learn more about the theory and practice of meaningful, inclusive, and safe patient and public engagement.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
About Clinical Trials and Its Potential Benefits of ParticipatingVial Trials
Are you interested in clinical testing and want to learn about its phases and the potential benefits of participating? Then you must go through this blog right here!
The Breast International Group (BIG) is the largest international network of academic breast cancer research groups. Facilitating international clinical trials is BIG's core expertise and for that reason, we have developed a slideshare presentation to explain the basics of clinical trials.
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Clinical trials constitute a critical stage of clinical research and it is important for you to understand what clinical trials are and what forms they take. In this slide deck, we will tell you more about the types and phases of clinical trials. The idea is to help you form a basic understanding of clinical trials. This is a two-part series and the next segment will focus on the things you must remember when preparing to publish a clinical trial manuscript.
Coming soon - Part 2: Things to remember when preparing a clinical trial manuscript
FDA 2013 Clinical Investigator Training Course: The Investigator as Collabora...MedicReS
FDA 2013 Clinical Investigator Training Course: The Investigator as Collaborator in Promoting the Clinical Research Enterprise
Neil J. Weissman, M.D., MedStar Health Research Institute
SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershmanbkling
Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman
Should I Participate in a Clinical Trial?Summit Health
This talk will review the importance of ongoing medical research and how it helps advance medical knowledge and promote the development of new treatments. We will discuss the research process, the protection of study participants, and how individuals may find and choose research studies to volunteer in at SMG or elsewhere.
Clinical Science for Medical Devices: A Guide for Entrepreneurs | Jim Gustafs...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Reasons for conducting clinical trialsJohn Douglas
To explain in simple terms, a clinical trail is a research in human volunteers to answer certain health questions. Carefully conducted clinical trails are the quickest and safest way to discover new treatment
methods that work in people and enhance their health.
2. Presenters
Catherine Gregor, MBA, CCRP, CCRC
Project Manager
ResearchMatch
Leslie R. Boone, MPH
Translational Research Coordinator
Vanderbilt University Medical Center
3. Today’s Objectives
• Discuss the role of clinical trials in advancing
research
• Review the methods and process of a trial,
including the phases of a study
• Review common features of trials for inflammatory
bowel diseases
• Discuss resources for more information
4. What is a clinical trial?
• Medical research studies that look for:
– New drugs or new combinations of drugs
– New procedures or devices
– New ways to use existing treatments
– Types of care, such as improving the quality of life for
people with chronic illnesses
• Also known as interventional study or clinical study
• Determine safety and effectiveness
5. The process from the start of basic research to
developing new drugs, treatments, or finding cures
takes an average of 13-20 years
2015… …2032
Lab
Clinical
Trials
Patient
Care
7. What is the hold up?
• 50% of clinical research sites enroll one or no
patients in their studies.4
• Eighty percent of total trials are delayed at least
one month because of unfulfilled enrollment.2
• Each day a drug is delayed from market, sponsors
lose up to $8 million.5
All statistics from The Center for Information & Study on Clinical Research Participation: http://www.ciscrp.org
1.Beasely, "Recruiting". 2008
2.Lamberti, "State of Clinical Trials Industry", 292
3.Pierre, "Recruitment and Retention". 2006
4.Beasely, "Recruiting". 2008
8. Imagine if the whole process took closer to 5 years
2015… …2020?That’s much
better!
9. Insert Poll
• Have you participated (or currently participating) in
a clinical trial?
Yes
No
10. Insert Poll 2
• If you answered no, what would you say is the main
reason?
No study in my area
I do not meet criteria for a study
I’m afraid of the risks involved
I do not feel knowledgeable about clinical trials
I am content with my treatments
Other
11. Why Don’t People Participate?
• Lack of opportunity
• Lack of knowledge
• Lack of comfort
12. Purpose Compensation, treatment for injury
Description Whom to contact
Procedures Right to refuse or withdraw
Risks Confidentiality
Benefits Clinicaltrials.gov (if applicable)
Alternatives
Deciding Whether to Participate:
Informed Consent
– Food and Drug Administration (FDA) requires that
volunteers are given information before they participate
– Informed Consent form includes:
13. Six Additional Elements
• Statement that there may be risks which are unforeseeable
• Under what circumstances investigator could terminate your
participation
• Additional costs to you
• Consequences of your withdrawal from the study
• When will research findings be disclosed to you
• Approximate number of people participating in the study
• You can still decide to withdraw from the study at any time
14. How do trials work? Study Methods
• 2 or more treatments
assigned by chanceRandomized
• Active drug or placebo?Double blind
• Inactive product
resembles study drug
• Continue course of
standard treatment
Placebo
15. Phases of Clinical Trial: Pre-Clinical
• In vitro (test tube or cell culture) and in
vivo (animal) experiments
• Wide-ranging doses to obtain
preliminary data on effectiveness,
toxicity and movement of drug within
body
• Determine if potential drug has
scientific merit for further development
as investigational new drug (IND)
17. Phase 1
• Determine safe dose
• How does the body work? Phase 2
Phase 4 Phase 3
Pre-Clinical
18. Phase 1
• Determine safe dose
• How does the body work?
Phase 2
• Safety and Effectiveness
• Any short-term side effects?
• Narrow criteria selection
Phase 4 Phase 3
Pre-Clinical
19. Phase 1
• Determine safe dose
• How does the body work?
Phase 2
• Safety and Effectiveness
• Short-term side effects
• Narrow criteria selection
Phase 4
Phase 3
• Is it better than standard
treatment?
• Evaluate risks/benefits
• Most expensive and difficult
Pre-Clinical
20. Phase 1
• Determine safe dose
• How does the body work?
Phase 2
• Safety and Effectiveness
• Short-term side effects
• Narrow criteria selection
Phase 4
• Observation of serious
side effects
• Interactions with other
drugs
• Tests in groups or special
populations
Phase 3
• Is it better than standard
treatment?
• Evaluate risks/benefits
• Most expensive and difficult
Pre-Clinical
21. Common Types of Clinical Trials
• Treatment Trial
• Prevention Trial
• Diagnostic Trial
• Quality of Life Trial
• Compassionate Use
22. Clinical Research Team
• Principal investigator
– Plans and leads the trial
– Typically a physician
• Clinical Research Coordinator
– Coordinates daily trial activities
– Main contact for volunteers
and staff
23. Clinical Trials for Inflammatory Bowel
Diseases (IBD)
• Trials are appropriate for many different types
of people
• Specific requirements vary by trial
• The more people who take part in clinical trials,
the faster we will find better ways to treat and
potentially cure IBD
24. Common features of IBD studies
• Clinical Trials identify “Endpoints” or goals that the
medication is meant to achieve
• Common Endpoints for IBD related clinical trials:
– Symptom improvement
– Improve quality of life
– Small bowel or colon healing
– Reduction in need for other medication (ex.
Corticosteroid)
– Improvement in blood or stool markers of inflammation
25. Special considerations of IBD studies
• Pediatric clinical trials require parental consent
• Financial considerations:
– Clinical trials often cover medication under investigation
and any measures (i.e. lab work, clinic visits, etc.)
relevant to endpoint being investigated
– Other treatments may not be covered
• Some studies provide continued medication for
patients who respond after specified trial endpoint
– Specific to each trial
26. Where can I find more information?
• Clinical Trials on CCFA.org
– www.ccfa.org/research/participate-in-research/find-studies-and-clinical-trials
• ResearchMatch
– www.researchmatch.org/partner/ccfa
• ClinicalTrials.Gov
– www.clinicaltrials.gov
• CCFA Partners
– www.ccfapartners.org
• Your doctor
27. We all want the same thing
• Working together to find answers faster!
• Goes beyond the limits of financial
contributions and allows for a bigger
impact made by all
• www.researchmatch.org/partner/ccfa
28. Questions and Answers
IBD Help Center
9 AM- 5PM EST
(888) 694 8872, via email at info@ccfa.org
Or Answerchat on our website
www.ccfa.org
29. Irwin M. and Suzanne R. Rosenthal IBD Resource Center
(IBD Help Center) M-F, 9:00 AM-5:00 PM ET
– Phone: 1-888-694-8872
– Email: info@ccfa.org
Educational webcasts: www.ccfa.org/resources/webcasts.html
Connect with other patients
– CCFA Community website: www.ccfacommunity.org
– Support groups and Power of Two (peer mentors):
– www.ccfa.org/chapters
GI Buddy
Online tracking tool and mobile app www.ccfa.org/gibuddy
CCFA Partners: Patient Powered Research Network www.ccfapartners.org
Local educational events, visit: www.ccfa.org
Additional Resources for IBD Patients