Carefully organized and conducted clinical trials are the foundation of leading medical research and drug development today. When set up correctly, these trials have the unique ability to provide critical information on the safety, efficiency, and clinical value of a potential treatment or product.
Clinical trials are research studies, so you must conduct them according to a planned protocol that outlines the guidelines, rules, and terms. The main objective is to improve human health as quickly and efficiently as possible. To ensure participant safety and reliable results, read through the following three steps to ensure your clinical trial is set up properly.
Develop a Well-Designed Protocol
Every targeted clinical study must begin with the development of a protocol. This document thoroughly describes how you will conduct a clinical trial, including the background, rationale, organization, methodology, and other statistical considerations. A quality-written protocol will ensure the safety of participants and the integrity of any collected data.
A well-designed research plan is essential for facilitating a quick study submission and approval process. ICH Good Clinical Practice guidelines state that a protocol should include the topics of general information, study design, safety and efficacy assessment, subject treatment, statistics, quality control and assurance, ethics, and data handling and recordkeeping.
Recognize the Value of Each Intensive Phase
While preclinical research in a laboratory setting can provide foundational data on the potential of a pharmaceutical product, nothing replaces studies that showcase how drugs directly interact with the human body. For this reason, you must always conduct clinical trials in a series of rigorous phases. Ergo, the second of the three steps to ensure your clinical trial is set up properly is to identify the importance of each stage in the lengthy process.
You must design each phase of the study to answer questions about the treatment candidate. Phase one studies typically study a drug’s effects on healthy volunteers. This step is key for evaluating safety before going further into the trial. Phase two studies dive deeper to study its effectiveness in people who have the disease or condition and determine optimal drug doses. Phase three then studies a larger population to identify if a drug candidate offers treatment benefits to a specific, targeted population. Phase 3 trial results often provide the basis data for safety and efficiency approval by the FDA.
Choose the Right Trial Support and Partnerships
A research team, institution, or company requires funding, outsourced support, and strategic partnerships to design the proper clinical trial setup. The right selection of potential partners from the start is of the essence to ensure successful project outcomes. A viable relationship between companies and manufacturers is confidential, cost-effective, and valuable to meet expectations of product integrity during development.
You can rely on Moravek to meet industry-specific standards for phase one trials worldwide. Moravek is a trusted contract manufacturing organization that provides API pharmaceutical manufacturing services. Our expertise in the field and superior track record showcase our compliance with Good Manufacturing Practice guidance. Learn more about our quality for clinical trials on our website today.