Understand an investigational product mechanism of action when prescreening in clinical research

This video provides an in-depth exploration of a critical aspect of patient pre-screening in clinical research: understanding the mechanism of action (MOA) of an investigational product. The speaker emphasizes that at the research site level, a thorough grasp of how the study drug works is paramount, particularly in relation to a patient's existing concomitant medications and medical history. This foundational understanding is presented as the most important factor in effectively evaluating potential study participants.

The discussion highlights the necessity of not only comprehending the MOA but also identifying the riskiest aspects of the investigational product. This proactive approach ensures that potential interactions, contraindications, or adverse events can be anticipated and mitigated during the pre-screening phase. The speaker outlines various resources available to research site personnel for acquiring this crucial knowledge, including direct consultation with the Principal Investigator (PI), sub-investigators (sub-Is), and the medical monitor. Additionally, the investigator's brochure is cited as a primary document, complemented by independent research through online searches to understand real-world drug interactions. The underlying rationale for this detailed investigation is that patients' primary concerns often revolve around how the study drug's MOA will interact with their current medications and health conditions.

The progression of ideas underscores a practical, site-level methodology for ensuring patient safety and trial integrity from the very first interaction. It moves from identifying the core information needed (MOA, risks) to detailing the authoritative and supplementary sources for that information, and finally, to acknowledging and addressing the patient's perspective. The speaker's approach is grounded in the realities of clinical site operations, offering actionable guidance for research coordinators and other site staff on how to prepare themselves to answer patient questions and make informed pre-screening decisions. This process is crucial for minimizing risks, optimizing patient recruitment, and maintaining the ethical standards of clinical trials.

Key Takeaways:

• Mechanism of Action is Paramount: The most critical element in pre-screening patients for a clinical trial is a deep understanding of the investigational product's mechanism of action (MOA). This knowledge forms the basis for assessing patient suitability and safety.
• Interaction with Concomitant Medications: It is essential to analyze how the study drug's MOA will interact with any medications a patient is currently taking. This prevents potential drug-drug interactions that could compromise patient safety or trial outcomes.
• Consider Patient Medical History: A comprehensive review of a patient's medical history is necessary to identify pre-existing conditions that might be affected by or interact with the investigational product's MOA. This ensures that the trial does not exacerbate existing health issues.
• Identify Riskiest Aspects of the IP: Research site staff must proactively identify and understand the most significant risks associated with the investigational product. This enables them to effectively counsel patients and monitor for potential adverse events.
• Leverage Principal Investigator (PI) Expertise: The PI and sub-investigators are primary resources for understanding the study drug's MOA and potential risks. Direct consultation with them provides authoritative insights and guidance.
• Consult the Medical Monitor: The medical monitor serves as another crucial resource for clarifying complex aspects of the investigational product, especially concerning safety and medical implications.
• Thorough Review of Investigator's Brochure (IB): The Investigator's Brochure is a foundational document containing comprehensive information about the investigational product, including its MOA, known risks, and pharmacology. It should be meticulously studied.
• Conduct Independent Research: Beyond official documents, site staff should perform their own research, including online searches (e.g., "Googling things" and "long tail search"), to gain a broader understanding of how the study drug and its components interact in real-world scenarios.
• Address Patient Concerns Proactively: Patients' primary concerns during pre-screening often revolve around how the investigational product's MOA will affect them, particularly in conjunction with their current medications. Being prepared to address these concerns builds trust and facilitates informed consent.
• Foundation for Patient Safety and Trial Integrity: A robust understanding of the investigational product's MOA and potential interactions is fundamental to ensuring patient safety, minimizing adverse events, and maintaining the scientific integrity of the clinical trial.

Tools/Resources Mentioned:

• Investigator's Brochure (IB): A comprehensive document detailing the investigational product.
• Principal Investigator (PI): The lead researcher at the clinical site.
• Sub-Investigators (sub-Is): Other qualified researchers working under the PI.
• Medical Monitor: A physician responsible for the safety of trial participants.
• Google: For independent online research and "long tail searches."
• Veeva Site Vault: (Mentioned in video description) A cloud-based application for clinical trial site management.
• Versatrial: (Mentioned in video description) A clinical trial management system.
• CRIO (Clinical Research.io): (Mentioned in video description) An eSource and CTMS platform for clinical research.
• Inato: (Mentioned in video description) A platform for patient recruitment in clinical trials.

Key Concepts:

• Mechanism of Action (MOA): The specific biochemical interaction through which a drug substance produces its pharmacological effect.
• Investigational Product (IP): A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. Also referred to as "study drug."
• Pre-screening: The initial process of evaluating potential clinical trial participants against basic inclusion/exclusion criteria before a full screening visit.
• Concomitant Medications (con meds): Any medications a patient is taking concurrently with the investigational product, whether prescribed or over-the-counter.
• Medical History: A record of a patient's past and present health conditions, illnesses, surgeries, and treatments.
• Research Site Level: Refers to the operational activities and responsibilities carried out by staff at the clinical trial site (e.g., research coordinators, nurses, PIs).