Treatment Trials Program

Geographic Scope: International (applications accepted worldwide)

Focus Areas:

• Target Conditions: Schizophrenia, Bipolar Disorder, and related psychiatric conditions
• Research Type: Clinical treatment trials testing novel pharmacological and non-pharmacological interventions
• Study Design: SMRI gives strong preference to randomized, double-blind studies

Eligibility

• Principal Investigator must have appropriate credentials and institutional affiliation
• Co-investigators allowed (up to 5 listed in application)
• Studies must have IRB (Ethical) approval before funding is released (approval status of "pending" acceptable at application submission)
• International applications welcome

What SMRI Supports

• Personnel/Salary costs for study staff
• Patient recruitment and retention costs
• Supplies and equipment necessary for the trial
• Indirect costs up to 15% of total project costs
• Consultant assistance (no cost to applicant) for:
  • Optimal trial design
  • Inclusion and exclusion criteria development
  • Clinical report form (CRF) development
  • Data management
  • Statistical analysis
  • Dropout data evaluation
  • Available consultants: Dr. John Davis (University of Illinois at Chicago, SMRI Associate Director) and Dr. Mark Weiser (Chaim Sheba Medical Center, Tel Aviv)

Funding Distribution

• 25% released in advance upon approval
• 65% paid quarterly based on number of patients randomized
• 10% released upon receipt of final report

Requirements and Policies

Data and Safety Monitoring Board (DSMB):

• Minimum 3 members, at least one from outside the institution
• At least one member should have biostatistics/clinical trial design expertise
• At least one member should have English proficiency (verbal and written)
• Meetings required at least every 6 months (teleconference acceptable)
• Written reports required at least annually and at study end
• All reports submitted to SMRI with fourth quarter report

Data Sharing Requirements:

• SMRI expects timely release of final research data (raw, individual patient data)
• Limited access datasets made available no later than 6 months after publication of main findings
• Data must be de-identified to protect participant privacy
• All researchers accessing SMRI data must execute Data Use Certification (DUC)
• SMRI follows NIH data sharing guidelines
• Applicants must explain any data sharing limitations in application

Special Trial Programs:

• Special Treatment Trials: Multi-center trials requiring >$300,000/year, usually for medications with promising preliminary SMRI-supported trial results
• Drug Development: Occasional support for promising medications at selected biotechnology companies (note: new applications not being accepted at this time)

Design Considerations

• Applicants may consider Sequential Parallel Comparison Design (SPCD) for placebo-controlled trials
• Interim analysis recommended for large trials
• SMRI may request protocol modification to combine data across trials on same drug
• Trimentum™ technology available through PPD for trial design and analysis

Contact Information: Available through stanleyresearch.org

Application Process

The treatment trial application consists of 7 parts submitted online:

Part 1: Investigators

1. List Principal Investigator (PI) with:
   • Salutation, first name, middle name, last name
   • Job title
   • Department
   • Institution name and address
   • Phone, fax, email
   • Degrees
2. List all co-investigators (up to 5 additional co-investigators) with same information
3. Required attachments: CVs for PI and all co-PIs (not to exceed 5 pages each)

Part 2: Treatment Trial Details

1. Fill in the following required fields:
   • Title of Proposed Treatment Trial
   • Primary Drug and Dose (required)
   • Secondary Drug and Dose (if any)
   • Target Population (required): Select from Schizophrenia or Bipolar Disorder
   • Total Sample Size (required)
   • Study Period for Each Subject (in days, required)
   • Length of Entire Trial (in years, required): Choose One Year, Two Years, or Three Years
   • Study Design (e.g., double blind, crossover, etc.)

Part 3: Abstract and Proposal

1. Abstract (500 words or less, including spaces):
   • Copy and paste abstract into text field
   • Optional: Attach charts/graphs via Media Upload
2. Proposal Summary (approximately 5 pages, required):
   • Include the following elements: a) Scientific rationale for the study, citing relevant basic research and prior clinical experience with the drug b) Detailed study design including outcome measurements c) Description of how compounds will be obtained
   • Copy and paste summary into text field
   • Figures and tables should be limited to 1-2 figures per application
   • Optional: Attach…