Early planning is critical, both for cell therapy clinical trials and commercial-scale operations. By addressing how activities will be managed early on, it can minimize risk and cost, and optimize downstream processes. However, oftentimes clients are unsure of which components are critical to address early on.
In this blog I’ll address the top question clients often ask me, “What are the key components of a cell therapy clinical trial that I should consider early on, and why?”
There are several factors but the most important include:
The way the study is designed is the crux of the clinical trial. It will directly affect the execution and logistics as you navigate through the development phases so it’s important that significant time and thought is put towards this step early on.
The more complex the study protocol design is (i.e. double blinding), the earlier it needs to be communicated. If not communicated, it can lead to logistical challenges such as packaging, labeling, as well as misinformed study personnel, all of which can cause delays in kickoff and/or implementation.
Early planning for the number of clinical sites and their locations has a direct impact on the execution of a cell therapy clinical trial. Remote or inaccessible clinical site locations will affect distribution of material as well as recruitment and treatment.
A team of qualified individuals are needed to support the clinical trial; especially a Principal Investigator. A PI with significant experience in study participant recruitment, patient follow-up and strong regulatory knowledge is important in choosing a study site.
The on-site personnel also affects the site location as they need proper clinical trials skills and on-going or up-to-date regulatory training. Without training, the cost of the trial can increase due to poor paperwork documentation, poor management of study product, and non-compliance with protocols.
Supply Chain Management
It is important to consider a coordinated supply chain management plan as early as possible within the therapies development. This will give you peace of mind that your product is delivered to the right patient at the right time, location, and temperature.
Additionally, as you scale it’s important that your vendors scale with you. When searching for an ideal supply chain partner to support, consider the following characteristics:
- Expansive knowledge of clinical trials
- Extensive manpower
- Regulated storage facilities
- Widespread distribution abilities
- Quality procedures
By considering these key components early on in your cell therapy clinical trial planning, it will lead to proper implementation, smooth operations and attainment of study objectives.