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(To be completed by BIPI: Tracking #___________________Date________)
ABCD
External Collaborative Research Application Form
Instructions:
Applicants may choose to submit either a brief study synopsis, full study proposal
or a study protocol for evaluation of External Collaborative Research grant
support. BIPI does not have a preference and will review all submissions
received.
 For synopsis submissions, please complete the following sections 1 & 2,
and sign and date the application. Please also provide supportive literature
citations and a signed/dated CV. If you choose this option, BIPI will review
and confirm strategic interest, after which we will request completion of
section 3 (full proposal).
 For proposal submissions, please complete the following sections 1-3,
and sign and date the application. Please also include detailed budget
information (BIPI does not require a specific format), supportive literature
citations and provide a signed/dated CV.
 For protocol submissions, please complete section 1 and submit your full
written protocol (BIPI does not require a specific format), and sign and date
the application. Please also include detailed budget information (BIPI
does not require a specific format), supportive literature citations and a
signed/dated CV.
All completed applications can be submitted to the following mailbox:
[email protected]
We will email you confirmation of receipt within 48 hours.
For any questions about the application process, please contact your assigned
Medical Science Liaison or send an email to
[email protected]
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Section 1- Administrative Information
Principal Investigator
Title
Organization
Department
Address
Phone
Fax
E-mail
Any additional staff to be cc’ed
(e.g. study coordinator,
administrative assistant)
Study Title
Study Type (pre-clinical,
interventional, noninterventional)
Number of sites
☐ Monocenter -Study
☐ Multicentre-Study, n = ____
☐ Multinational Study, countries = _______(please list)
Required Support
☐ Financial Support
☐ Study drug originated by BI
☐ Other (please specify): ............................
Please read and acknowledge the following statements:




I understand that External Collaborative studies supported by BI must follow all relevant International and National
laws, as well as applicable ethical and scientific guidelines, (e.g., ICH E6, GCP Compliance Guideline).
I will deliver adverse events to BIPI in accordance with local regulatory and BI global reporting requirements.
I have attached a signed/dated CV
I have provided supportive literature citations as an attachment
Signature of Principal Investigator
_____________________________
_________________________________
[Please insert place and date]
[Please insert name]
Principal Investigator
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ABCD
External Collaborative Research Application Form
Section 2- Synopsis of Research
BI Study Substance to be studied
Therapeutic Area
☐ Metabolism (Diabetes)
☐ Cardiovascular
☐ Respiratory
☐ Oncology
Non-BI drug(s) as part of the study
(as applicable)
Disease State / Indication
Please state the medical condition of the
patients being studied/indication for
treatment.
Also indicate the stage which best
characterizes patients to be enrolled in this
study, if applicable.
Study Phase
☐ Phase I
☐ Phase II
☐ Phase III
☐ Phase IV
☐ Preclinical
☐ Not Applicable: please describe:____________________
Medical/Scientific Rationale
(attach supportive literature citations at end of application)
Please provide the reason for conducting the
study based on current knowledge and
existing data; please also provide cited
references to support this rationale.
Study Objective
Hypothesis to be generated or tested. A
concise statement of the major and minor
questions that the trial is designed to
answer in order of importance or relevance.
Primary and Secondary Endpoints:
The primary endpoint should be capable of
providing the relevant and convincing
evidence to address the primary objective
(hypothesis). In general the primary efficacy
endpoint should reflect accepted norms in
practice and be both reliable and
standardized.
Secondary endpoints may either be
supportive of the primary objective or
address the secondary objectives
(hypothesis) under study. The number of
secondary endpoints should be limited to
the number of outcomes under study
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Study Overview:
Provide a brief explanation of the
experimental design including the disease to
be treated, its stage and line of treatment (if
applicable), randomization (if any), controls
or comparator drugs (if any), approx.
number of subjects to be enrolled,
involvement of multiple institutions, number
of study visits and estimated duration of
study from first patient in to first results
available.
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External Collaborative Research Application Form
Section 3- Full Proposal Details
Names, address and contact details of
additional sites (if available)
Study Design
☐ Prospective
Please select all that apply
☐ Retrospective
☐ Randomized
☐ Non-Randomized
☐ Non-Controlled
☐ Placebo-Controlled
☐ Comparator-controlled
☐ Blinded
☐ Open-label
☐ Parallel arm--please indicate number of arms n=____
☐ Cross-sectional
☐ Cross –over
☐ Exploratory / Pilot
☐ Confirmatory
☐ Other, please describe:_______________
Inclusion Criteria
In designing Inclusion and Exclusion criteria it is
important to include criteria that would ensure
scientific validity and exclude subjects from
enrollment who might be put at unacceptable risk.
Eligibility criteria should support scientific rationales
and address any regulatory issues and practical
concerns; should be straightforward and
unambiguous. Please include any testing/lab
values that will also be used in the final protocol for
inclusion.
Exclusion Criteria
In determining exclusion criteria for drug studies,
the author is referred to the product investigational
brochure or package labelling regarding known
safety considerations and contraindications to drug
treatment
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Treatment Plan and Dosing Regimen,
including planned visit schedule
The study design should provide an explanation of
the experimental design and contain a brief
stepwise description of all procedures required by
the study. Please consider initial evaluations,
screening tests, non-standard of care lab tests,
details of treatment intervention and ancillary
procedures, as well as dose scheduling,
modification, and appreciation for study visits. A
study flow chart is highly recommended. It should
display timing of planned interventions as well as
all clinical and laboratory measurements and the
time periods (e.g., hours, days, weeks) at which
data are to be collected.
Please attach a study flow chart with this
application if appropriate.
Please also consider:




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Treatment plan and therapeutic goals
Comparator treatment products (if applicable)
Dosage and dosing regimen for all study periods
Route of administration for study products
Blinding techniques (if applicable)
Study Drug Strength and Quantities:
Please detail the drug required for the study and the
quantity needed. Please include any detail on packaging
requests.
Is any Translational Research
planned?
If yes, please describe- quality of life,
PK, Biomarkers etc.
☐ No
☐ Yes: please describe below:____________
Number of Subjects and Power
Calculation
 Sample size (total)
 Number of patients per treatment arm
A power calculation needs to be included that
substantiates the target enrolment needed to show
detectable difference relative to the primary hypothesis.
This calculation should take the form of a
comprehensive summary that includes assumptions.
Checklist for statistics:
1. (One-sided or two-sided) alpha
2. Power or beta
3. Expected effect size for control treatment (based on
historical control with reference, e.g. median PFS,
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median OS, objective response rate, etc., depending on
primary endpoint)
4. Expected effect size for experimental treatment (e.g.
expected/relevant hazard ratio or median PFS (OS),
response rate, etc., of experimental treatment)
5. Used test/design (e.g. Log-rank test, binomial test,
Simon-two stage design, etc.)
Statistical Methods
 Statistical approach
 Primary study population (FAS, PPS, other)
 Interim analysis (if applicable)
All planned primary analyses and key secondary
analyses should be discussed in this section. If other
secondary and tertiary analyses are planned, then a
statement should be included in this section as to what
these analyses are. Describe in detail the statistical
methods that will be used for the primary hypotheses or
estimation. State the statistical tests which will be used
(e.g., ANOVA, Kaplan‐Meier) along with other
important considerations (e.g., factors in ANOVA, pre‐
specification of covariates, strata for Mantel‐Haenszel,
use of historical controls).
Study Duration and Timelines
Best case scenario based on feasibility
CTA= Clinical Trial Agreement signed
FPI= First Patient in
LPI=Last Patient In
LPO= Last Patient Out
Months per step
Months Cumulitive
CTA to FPI
FPI to LPI
LPI to LPO
LPLV= Last Patient Last Visit
CTR= Clinical Trial report
LPO to LPLV
LPLV to Database Lock
Database Lock to CTR
CTR to Publication
Publications
Planned # of Abstracts: ___________________
Planned scientific meeting(s) under consideration for presenting study
results:_________________
# of Anticipated Manuscripts: _______________
Target date for submission:________________
(primary manuscript)
Name(s) of Journal(s):_________________
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Study Budget
Please add detailed budget plan as appendix to
this study outline as an excel spreadsheet
Personnel Costs: (please indicate % effort also)
As applicable, please detail costs for:
Research Nurse
Study Coordinator
Safety Support
Statistical Support
Study Monitor
Data Manager
Regulatory Support
Other
Total Study Personnel Costs:__________
---------------------------------------------------------------------------------Other Costs:
As applicable, please detail costs for:
Regulatory Fees
Pharmacy Fees/ Study Medication
Data Management
Translational Research
Laboratory/Diagnostic
Clinic Costs
Publications
Institution Overhead
Other Administrative Fees
Total Other Costs:________________
---------------------------------------------------------------------------------Total Study cost:________________
Per subject cost:___________
----------------------------------------------------------------------------------
Number of Sources of Funding (other than BI):________
----------------------------------------------------------------------------------
Total funding requested from BI___________
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