Clinical Research with Cannabis-Based Medicines (SL#0028)
Learn how to produce a clinical trial that will generate sufficient clinical evidence through a regulatory compliant, well designed and high-quality clinical trial.
Learning Objectives: This course is a “must have” for companies and investigators who plan clinical research with cannabis-based treatments and wish to perform the most reliable, robust and regulatory compliant clinical trial with valid and undisputable results.
Clinical research with cannabis-based medicines course is a comprehensive overview of the most fundamental elements in clinical development that are directly linked to the very specific nature of the Cannabis-based treatment.
The course is compiled of ten (10) focused modules that revolve around the critical concepts for conducting compliant and effective clinical trials with cannabis-based drugs.
How Learned: Self-Paced – 10 modules. For the most efficient learning experience, we recommend that you do not exceed more than one module per day.
Language: The course is taught in English.
Time Limit: The course will be available for 6 months from the day of purchase.
MODULE 1: Why Clinical Trials with Cannabis-Based Drugs are So Essential?
At the end of this module, you will understand the biggest unmet need that exists in the space of clinical trials with cannabis-based drugs. You will be able to differentiate the two main parameters that compose this need: absence of sufficient clinical evidence that is of high quality, robust and valid and the absence of regulatory compliant, gold standard clinical trials that are able to generate such evidence. You will further understand the concern that is conveyed by the medical and scientific communities about potential bias and confounding parameters as well as regulatory incompliance of such trials. Lastly, you will realize the efforts that should be made to answer this need.
MODULE 2: The Legal and Regulatory Landscape
At the end of this module, you will be familiar with specific country-by-country requirements and/or hurdles that concern the approval and execution of a clinical trial with cannabis-based drugs. This module provides key information for your pursuit after the most suitable location for clinical development.
MODULE 3: The Indication Challenge and Impact on Trial Complexity
At the end of this module, you will be able to choose a practical, measurable and accessible indication with validated and regulatory-accepted endpoints while considering the special nature of cannabis-based treatments and how these correspond with the special considerations that were discussed.
MODULE 4: Critical Trial Design Considerations, Part A
At the end of modules 4 and 5 (Part A and Part B), you will be able to consider and apply appropriate design characteristics in this unique clinical development of cannabis-based treatments to accomplish a reliable clinical study with valid and dependable results.
MODULE 5: Critical Trial Design Considerations, Part B
At the end of modules 4 and 5 (Part A and Part B), you will be able to consider and apply appropriate design characteristics in this unique clinical development of Cannabis-based treatments to accomplish a reliable clinical study with valid and dependable results.
MODULE 6: Statistical Principles for Trials with Cannabis-Based Drugs
At the end of this module, you will be able to determine whether your overall statistical considerations adhere to appropriate industry pharma standards and such that avoid pitfalls in data analysis and results bias. You will be able to increase your certainty in your development plan and assure that definition of measures as well as data analysis are done in a way that regulatory bodies and the scientific communities acknowledge the value of your data.
MODULE 7: Safety Aspects for Trials with Cannabis-Based Drugs
At the end of this module, you will be familiar with the most common adverse events for short and long term that are associated with the use of cannabis-based drugs. You will be able to implement in your studies the available information about contraindications, drug interactions, and population that must be excluded. This module is critical to your clinical protocol. You will be able to generate a more efficient safety evaluation that considers the known drug safety pitfalls and will lead you more accurately towards your final goal of safety and tolerability assessments.
MODULE 8: Drug Formulation Challenge
At the end of this module, you will be able to understand clearly one of most critical challenges in the development of cannabis-based drugs and apply a set of rules that will enable you to reach the “totality of evidence approach”, as required by US-FDA.
MODULE 9: Regulatory Aspects
At the end of this module, you will be aware of the mandatory pieces of information that are crucial for a successful clinical trial submission sided to unique regulatory strategy and regulatory pathways that will assist you during your regulatory endeavor.
MODULE 10: PharmaEconomical Aspects of Cannabis-Based Drugs
At the end of this module, you will understand the importance of health economics measurements in clinical research, and more specifically in the clinical research of cannabis-based drugs. You will learn about the timing to apply such measures and the commonly accepted endpoints that could be used in cannabis-based drug trials. You will be able to create your own drug’s value story that will support your drug reimbursement application or health coverage application. Lastly, you will be able to create a 3-stage plan that will assure appropriate pharmaeconomical positioning of your product.