Grant Program Overview
The Daner’s Grant has been established to fund human clinical trials in cancer treatment that incorporate cannabis in an effort to develop nontoxic, non-habit forming novel therapeutic cannabis based cancer drugs.
Daner’s Grant has identified numerous knowledge gaps on how cannabinoids activate different physiological reactions through the Endocannabinoid (ECS) receptors and how they interact with the human body at the cellular level through different delivery systems. Also lacking, are the data on correct standards for dosage and levels of toxicity, measuring short and long term side effects and assessing the therapeutic efficacy from a wide range of THC : CBD concentrations in different cannabis products.
The aim of the grant is to fund clinical trials that are planning to explore any of the following general areas:
- Measure the efficacy of one or more cannabinoids (natural or synthetic) as anti tumoral agents in a wide range of cancer cells in adult patients undergoing chemotherapy treatment.
- Develop cannabinoid-based combinational therapies by combining administration of cannabinoids (at different concentration levels) with other anticancer agents to act synergistically to inhibit tumor growth.
- Explore the tolerability and safety associated with the administration of cannabinoids (natural or synthetic) through the best possible delivery system for the treatment of nausea, vomiting and appetite loss in adult patients who are undergoing chemotherapy treatment.
- Study the effects of cannabis on diet, nutrition (including body composition) and physical activity of patients undergoing chemotherapy treatment.
The definition of ‘cancer’ includes the whole cancer process, both before and after diagnosis, from incidence to survivorship, local progression, distant metastasis and cancer mortality.
This section provides applicants with the eligibility criteria for Daner’s Grant and details of the submission and review process.
- Daner’s Grant will fund only human clinical trials for which experimental designs (pre-clinical trial) in-vivo or in-vitro have already been performed and the results published in a reputed journal.
- Must be relevant to human cancer.
- Institutional Eligibility – All North American public or private, non-profit or for-profit research institutes, laboratories and hospitals are eligible to receive Daner’s Grant.
- Must have a strong multi-disciplinary research team with prior experience in medical cannabis research, which has the capabilities and expertise to run clinical trials.
- The institute should have either existing relationships or the ability to co-ordinate with different federal organizations such as NIDA, FDA, DEA, NIH and HHS for necessary clearances to pursue medical cannabis trials.
- The institute should have clinical trial and data collection practices in place that follow the general FDA guidelines to support effectiveness claims in new cancer drug applications (NDAs), biologics license applications (BLAs), or other supplemental applications.
- The clinical trial outcomes should be specific and well defined and should follow general FDA guidelines to outline cancer endpoints as well as recognized surrogate markers of cancer in order to receive the grant.
Grant Submission Process: How To Apply
1. Writing your application
All grant applications should be submitted to firstname.lastname@example.org. The grant application should include the following documentation for the clinical trial:
- Specify Grant type - Type 1: New, Type 2: Renewal, Type 3: Revision /Supplement, Type 4: Extension
- Detailed study description
- Scope and limitations of the trial including age group, sex, race, dose, cancer type, cancer stage, etc.
- Trial procedures
- Enrollment criteria and projections
- Sample size
- Study locations
- Trial design and protocol optimization
- Primary and secondary objectives
- Primary and secondary outcome measures
- Arms and Interventions
- Dose frequency, dose-response, measure side effects and other safety and efficacy characteristics
- Inclusion and exclusion criteria
- Collecting Core data - What will be considered a core data? How will you avoid collecting non-core data?
- Detailed breakdown of projected trial cost and timeline estimates
- Specimen control process that will outline the procedures of collection, handling and storage of biological samples and cannabis
2. Application Referral and Review
All DHF Grant applications will be assessed by a scientific advisory board (SAB) consisting of a team of doctors and research scientists in a way that is fair, equitable, timely, and free of bias. Applications will be evaluated based on the impact of the study in relation to potential for translation into new drug applications, usefulness to other researchers in the field, influence on public health, and several other criteria. Foundation will notify the applicant directly about its decision to approve or deny the funding.
3. Post-Award Monitoring and Reporting
Grantees must communicate with Daner’s Foundation regularly through bi-weekly or monthly meetings to update on progress, roadblocks, trial related issues, submit required reports on scientific progress of the grant, financial expenditures, invention reports, and more.