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CLINICAL TRIAL PROTOCOL
DEVELOPMENT
AND
INVESTIGATORS BROCHURE

Dr Urmila M. Aswar,
Sinhgad Institute of Pharmacy, Narhe,
...
Protocol writing

It is a complete written description and scientific
rationale for a research activity involving human
su...
Writing a Protocol – First steps

 The PI must know the answers for
 Is it reasonable? Do we have the resources?
 What ...
Who Reads Protocols?
• The protocol language/ content should be
understood by
– Other physicians
– Nurses/CRAs
– IRB membe...
Templates availability
• Many NIH programs encourage to use the
protocol templates available eg.
– http://ctep.cancer.gov/...
Parts of the Protocol
1.
2.
3.
4.
5.
6.
7.
8.

Introduction/Abstract
Objectives
Background/Rationale
Eligibility criteria
...
1. Objectives
• Objectives should be stated clearly as
hypotheses to be tested.
• Each objective should have a correspondi...
2. Background and Rationale
• All protocols require a section detailing the
scientific rationale for a protocol and the
ju...
Background and Rationale
• Double check all citations
• Common mistakes
• Name misspellings (including wrong initials),
wr...
3. Eligibility criteria- defn.
• Inclusion and exclusion criteria are the
conditions that must be met in order to
particip...
Writing Eligibility Criteria for Patient
• Eligibility criteria are the largest barrier to
clinical trials.
• There is no ...
The points to be considered to write a
good eligibility criteria
1. The number of eligibility criteria should be
kept to a...
4. Eligibility criteria should be straightforward
and unambiguous. Which of these criteria is
better understood?
1. Pregna...
Failure to write eligibility criteria
properly
• Leads to
Failure to mimic clinical practice
Increased study complexity
In...
Example
• Eligibility criteria given by National Institute of
Neurological Disorders and Stroke’s
for recruiting
participa...
4. Study Design
• The study design section of the protocol
should contain a stepwise description of all
procedures require...
Study Design
• Parts of the study design section may
include:
 Initial evaluations
 Screening tests
 Required lab tests...
5. Safety
• Adverse effect and side effect are terms
commonly associated with drugs. They are used
by nurses and doctors, ...
6. The Statistical Section
• The study objectives and study design
elements in the statistical section should
be described...
7.Human Subjects Protection
• This section includes discussion of:
– Subject selection and exclusion
– Proposed methods of...
Informed Consent
o Disclosure of relevant information to prospective
research subjects
o Comprehension of the information ...
The protocol’s informed consent must
provide
• Statement that the study involves research
• Purpose of the research and th...
Tools for Better Writing: Proofreading
Working too long on a protocol may habituate eyes
and brains to mistakes, simply be...
• Aoccdrnig to a rscheearch at
Cmabrigde Uinervtisy, it deosn't
mttaer in waht oredr the ltteers in a
wrod are, the olny i...
NIH Guidance on Protocol Writing
• Protomechanics:
http://www.cc.nih.gov/ccc/protomechanics/

• The Office of Human Subjec...
INVESTIGATORS BROCHURE
IB
• It is a comprehensive document summarizing
information about an investigational product
obtained during a drug trial....
• It sd provide the information for management
of CT and safety during CT
•
•
•
•

Dose (of the study drug)
Frequency of d...
IB contains Summary of Data and
Guidance for the Investigator
• Provide the investigator with a clear
understanding of the...
• The information should be based on the
available physical, chemical, pharmaceutical,
pharmacological, toxicological, and...
IB
• Detail guideline is provided in GCP and ICH
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Cinical trial protocol writing

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Important aspects of protocol writing, Investigators Brochure

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Cinical trial protocol writing

  1. 1. CLINICAL TRIAL PROTOCOL DEVELOPMENT AND INVESTIGATORS BROCHURE Dr Urmila M. Aswar, Sinhgad Institute of Pharmacy, Narhe, Pune -41
  2. 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
  3. 3. Writing a Protocol – First steps  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
  4. 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
  5. 5. Templates availability • Many NIH programs encourage to use the protocol templates available eg. – http://ctep.cancer.gov/guidelines/templates.html • Following template guidelines can help guide authors with proper modifications.
  6. 6. Parts of the Protocol 1. 2. 3. 4. 5. 6. 7. 8. Introduction/Abstract Objectives Background/Rationale Eligibility criteria Study design/methods (including drug/device info) Safety/adverse events Regulatory guidance Statistical section (including analysis and monitoring) 9. Human subjects protection/informed consent
  7. 7. 1. Objectives • Objectives should be stated clearly as hypotheses to be tested. • Each objective should have a corresponding discussion in the statistical section.
  8. 8. 2. 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.
  9. 9. Background and Rationale • Double check all citations • Common mistakes • Name misspellings (including wrong initials), wrong journal names, wrong years of publication, and wrong volume numbers
  10. 10. 3. Eligibility criteria- defn. • Inclusion and exclusion criteria are the conditions that must be met in 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.
  11. 11. 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
  12. 12. 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.
  13. 13. 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.
  14. 14. Failure to write eligibility criteria properly • Leads to Failure to mimic clinical practice Increased study complexity Increased costs Less number of patient getting recruited
  15. 15. Example • Eligibility criteria given by National Institute of Neurological Disorders and Stroke’s for recruiting participants for a clinical trial titled Study of Brain Activity During Speech Production and Speech Perception. • The inclusion criteria specified for the experimental group were (a) right-handed children and adolescents, (b) native speakers of American English, and (c) stuttering or phonological disorders. • The comparison (control) group consisted of normally developing right-handed children and adolescents who were native speakers of American English. • Exclusion criteria were (a) language use in the home other than American English, (b) speech reception thresholds greater than 25 dB, and (c) contraindications to magnetic resonance scanning.
  16. 16. 4. 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.
  17. 17. Study Design • 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
  18. 18. 5. 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 including reporting to the FDA and/or the sponsor • Unblinding processes (if applicable) • Lists of expected adverse events events,
  19. 19. 6. 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.
  20. 20. 7.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
  21. 21. 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.
  22. 22. 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
  23. 23. 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. – A document should be checked by automatic software – The document should be proofread.
  24. 24. • Aoccdrnig to a rscheearch at Cmabrigde Uinervtisy, it deosn't mttaer in waht oredr the ltteers in a wrod are, the olny iprmoetnt tihng is taht the frist and lsat ltteer be at the rghit pclae.
  25. 25. NIH Guidance on Protocol Writing • Protomechanics: http://www.cc.nih.gov/ccc/protomechanics/ • The Office of Human Subjects Research: http://ohsr.od.nih.gov/info/info.html • The NCI Investigators’ Handbook: http://ctep.cancer.gov/handbook/index.html
  26. 26. INVESTIGATORS BROCHURE
  27. 27. IB • It is a comprehensive document summarizing information about an investigational product obtained during a drug trial. • The IB is updated with new information as it becomes available. • Compile data relevant to studies of the investigational drug in human subjects gathered during preclinical and other clinical trials.
  28. 28. • It sd provide the information for management of CT and safety during CT • • • • Dose (of the study drug) Frequency of dosing interval Methods of administration Safety monitoring procedures
  29. 29. IB contains Summary of Data and Guidance for the Investigator • Provide the investigator with a clear understanding of the possible risks and adverse reactions, details of tests, observations, and precautions that may be needed for a clinical trial
  30. 30. • The information should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product. • Should also provide treatment of possible overdose and adverse drug reactions. • The IB should be reviewed annually
  31. 31. IB • Detail guideline is provided in GCP and ICH

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