Clinical Trial Design Best Practices

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When it comes to designing your next clinical trial, well-planned and executed study management is key. There are so many moving parts to designing a clinical trial protocol, it is important to make sure you are working with a trusted clinical trial management partner to help streamline the process as a whole. This in turn can help you mitigate any unnecessary risks, avoid delays, and keep on budget.

Here are some items to consider when considering your next clinical trial design:

Keys to Better Clinical Trial Design

1. Simplify Your Trial Design

As you design your clinical trial protocol, consider how you are approaching your trial’s scheduling. Multi-cycle, multi-visit, long-running studies often carry more variability in terms of risk and scheduling complications than trials with a more streamlined, simplified schedule. If your trial must operate in multiple cycles/visits over a longer period of time, then take careful consideration of how you define those visits within your clinical trial design. Simplifying this part of your design will help provide the freedom that will inevitably be needed for sites to see patients over a long-running study, and to adjust visit days accordingly so that the overall data can work more smoothly. 

For example, in a study where you’re on cycle 10 or 11 of dosing with 3-5 visits per cycle, it can be confusing to design your trial so that visits are named as day 300. When patients are part of longer-running trials, there are oftentimes delays that occur due to aspects such as site availability and patient scheduling. Instead of naming visits as the exact day, it is taking place in the clinical trial process, it is much simpler to manage visits from a data perspective when they are called “Cycle 10, Day 5” rather than “Day 300.”

2. Re-Think Your Sample Collection Schedule

To help streamline your study, it is important to design your clinical trial with a simplified sample collection schedule in mind. When you cycle your sample collection at different rates, that can create a lot of variability from visit to visit, which in turn creates more risk at the site level. It can be harder to keep track of and require more materials if you have samples collected multiple times in a cycle, rather than having everything collected every 3-4 visits. When you streamline your sample collection schedule, it can help your site to administer testing more efficiently and for your study management team to supply the necessary kits for the site to use. 

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3. Consider Your Restrictions

When developing a protocol, take time to understand any sample collection restrictions you might have in mind. Oftentimes, sample collection restrictions, particularly in regards to blood collection volumes, are written into a protocol without a proper understanding of how such restrictions affect the laboratory. Writing such restrictions into your protocol risks hampering your central lab’s ability to test and collect data in a timely and efficient manner. These restrictions can also lead to canceled testing if there are any issues with the testing schedule that come up along the way. They can also cause a need for protocol amendments or clarification to expand blood volume later on in the trial, further delaying the overall process.

4. Mitigate Your Future Adjustments

When you work with a trusted study management partner, make sure to go over any potential areas that are at risk for adjustment later on in the trial process. As noted above, this is especially relevant for any restrictions you have written into your study’s protocol. Adjustments made after a trial has already been started have the potential to affect all levels of the clinical trial process, causing study delays and cost increase. Having your study management partner advise on any blood volume restrictions you may have prior to the finalization of your protocol could save you both time and money in the long run.

5. Understanding Your Study Supplies

Delivering laboratory kits is more than packing tubes in bags or boxes. It is the culmination of all the study start-up activity and database development. For example, at ACM Global Laboratories we do not ship kit supplies out until we know they could be collected that exact day they are received. This is to help ensure that when kits are out in the field they are ready to go immediately for use.

Read Our Blog: Key Considerations for Clinical Trial Specimen Collection

Experienced Study Design Experts

At ACM Global Laboratories, we understand that there is no cookie-cutter, one-size-fits-all clinical trial. Each study protocol operates on an extensive blueprint, with a goal of researching and evaluating the risks and benefits of new drugs and other therapeutic treatments, utilizing a vast array of materials and resources. These elements can vary depending on the sponsor, therapeutic area and hypothesis, which is why enlisting experienced partners who offer end-to-end support in the clinical trial process is paramount to a successful trial, be it an exploratory FIH (first in human) initiative or pivotal trial.

We work with you to understand the unique needs of your clinical trial, every step of the process. Our expert Study Management team is here to help deliver tailor-made solutions to help ensure the success of your next study.

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About ACM Global Laboratories

Since 1975, ACM Global Laboratories has been a recognized leader in global clinical trial testing services. Through wholly-owned facilities and partner laboratories, we support clinical trials in more than 65 countries around the globe.

Learn more about how we can support your next trial and contact us today.

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ACM is an experienced partner to guide you every stage of the clinical trial process.

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