A clear and well-documented clinical development plan (CDP) is the foundation of any good clinical study. In fact, it is a requirement for any pharmaceutical company that intends to develop and test a new drug. The CDP is a description of clinical trials that will be carried out on a drug to assess its safety and effectiveness. It covers everything from the reason for development to the features of the trial, timelines, costs, and other resources. Therefore, a good CDP must take into account regulations surrounding clinical trials, as well as good clinical practices.
If you’re getting started in the clinical research program at AAPS, you can expect to cover the organization of clinical trials as well as the development and monitoring of a clinical plan. To get you started, here are some key things to consider when creating a clinical development plan.
Consider the Goals and Life Cycle of a Clinical Product
A good CDP starts by defining the product profile: the reason for producing the product and its intended effect. From there, you can set the goals and objectives for the clinical development of a product. The CDP needs to cover the different stages of a clinical trial, with plans to evaluate and assess the original goals at each stage.
Generally, pharmaceutical companies will be seeking new drug solutions to an existing or growing health problem. In that case, the CDP will need to consider the relative goals of the new product compared to other products out there. It will also rely on scientific data to set the minimum requirements for safety and efficacy.
Using practical and current real cases, AAPS provides students in clinical research courses with the foundation and practical knowledge to build the framework of a sound clinical development plan.
A good clinical development plan should lay out the goals of the new product
Use Your Regulatory Knowledge from Clinical Research Courses
The ultimate aim of a clinical development plan is to obtain regulatory approval for a new pharmaceutical product. That means an understanding of current regulatory standards is essential, including those relating to:
- The safety & maintenance of research sites
- The consent of trial subjects
- The qualifications of clinical personnel
- Record-keeping
A CDP aims to get regulatory approval for a new product
A good clinical development plan needs to account for the legal parameters surrounding a clinical research project and makes it clear what documentation is needed at each stage. This will ensure that a trial can go ahead as planned and that its results are deemed valid. Clinical research training at AAPS will focus on the Canadian regulatory agencies, as well as international guidelines and standard operating procedures. Students will learn about the required documentation for a clinical development plan to ensure compliance at every stage.
Clinical research training will teach you about regulatory standards for a CDP
Include Estimates for Project Resources
Clinical trials are long and costly procedures. To ensure they run smoothly, it’s important to develop a plan that accounts for the time and money that needs to be spent on each stage of the trial. This includes:
- The hiring of personnel
- Deadlines for decision-making
- The estimated cost
- Timelines for post-approval activities
With a clear CDP, clinical professionals can ensure they are on schedule for the trial, approval, and release of new products. At AAPS, you’ll cover on-site budget management for a clinical research project, including planning and preparing costs for each stage.
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