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Prioritized Challenges and Potential Strategies Building consensus around key design characteristics
Selecting qualified vendors<br>
03
Tool 1: Trial Design Phase Toolkit Protocol development map:
Timeline of key decision making deliverables
Subgroup meetings to draft the sections, main group meeting to assemble everything, individual team refinement meetings as necessary
Examples of an design oversight plan plan that is unique to the planning stage…
Chart of key decision makers and stakeholders and how they contribute to the protocol’s development<br>
04
Tool 1: Trial Design Phase Toolkit Protocol Template
Basket protocol framework
Umbrella/platform protocol framework: master protocol and appendices or sub-studies
Options for how to structure the master protocol given key disease characteristics, drug pipeline characteristics based on actual master protocol studies
Choosing a master protocol subtype based on disease characteristics, drug pipeline characteristics
Also details examples of implications of key decisions
Example in adaptive trial you have to decide if you are going to be master protocol driven or appendix driven?<br>
05
Tool 1: Trial Design Phase Toolkit Design Planning Toolkit:
Contract templates:
Understand the legal flow through across corporate, site, and vendor contracts…
Key contracting considerations: IP, data ownership, access to data across substudies, publication guidelines, extra samples
Need to make sure each contract covers the study structure that was chosen…<br>
06
Tool 1: Design Phase Toolkit Consent framework
Example a two-step consent process (consent to the master, consent to the sub-study)
Training toolkit for sites…this will cross over to execution
Data management options
Biospecimen collection and storage
Safety management options<br>
07
Tool 1 Data Needs Tool development process
Reach out to existing trials:
I-SPY
LUNG-MAP
NCI-MATCH
DAIN-TU
EPAD
STAMPEDE
FOCUS 4
Case research to draw out key teams
Assembling existing presentations, literature to develop some specific tools<br>
08
Tool 2: Vendor Assessment Toolkit Vendor communication guide:
Support stakeholders with thinking through how to provide detailed, comprehensive information
Make sure the vendor understand the open-ended nature of perpetual trials because it doesn’t fit the traditional cost structure
Vendor chart that describes specific key types of vendors that will fulfill critical functions within the trial
Need to be particularly sensitive to nonprofit and academic centers that may have to engage more vendors and get multiple bids
General list of considerations that may be unique for different types of master protocol studies<br>
09
Tool 2: Vendor Assessment Toolkit Set of RFI/RFPs that ask a key set of questions:
Ask potential vendors to provide details about specific challenges they anticipate given the trial design and how they have addressed those challenges in the past
Anticipate multiple rounds of this process<br>
