Congratulations! Your Clinical Research Is Approved. What Do You Do Next?

Having your proposal approved is one step closer to conducting your clinical research. But before you move on to perform the actual clinical trial, you must hold a pilot study to see if the project is feasible. It’s also a great way to make adjustments to the protocol, if necessary.

Pilot studies can play a critical role before conducting a full-scale research project.

A pilot study is a small-scale, preparatory investigation. It tries to examine important elements of the primary clinical research – generally known as a randomized controlled trial or RCT – to help assess the success of the study.

A pilot trial can help answer a simple question: Can a full-scale study be completed in the way it has been planned, or do we need to alter some components for successful execution?

Because clinical trials require a lot of resources to be carried out, the researchers must have confidence in their protocol. A smaller-scale study should be carried out to provide a more focused approach and ensure the appropriate allocation of time and money by the protocol.

What elements do pilot studies focus on?

A pilot study can focus on one or more of the following essential components of full-scale clinical research. They fall into one of the following three categories:

  • Process: where the probability of the critical steps in the main study is evaluated. For example, recruitment rates; participant retention levels, and eligibility criteria;

  • Resources: examining issues related to time and funding that may come up during the full-scale study. For example, using certain types of equipment over others to save on cost, or allocating the appropriate amount of time to observe participants;

  • Management: issues with data management and with the overall team involved in the study are examined. For example, the pilot study aims to explain if there were problems with collecting all the data needed for future analysis. It can also analyze how to store the data and whether the collected information is variable or collectively analyzed.

The last element is especially vital because collecting and analyzing data can be an excruciatingly long and challenging process. This is where Kohezion comes into action and helps clinical researchers collect and store data with custom database solutions. With Kohezion, clinical researchers have a better advantage of starting quickly and stretch their budget.

What should be some key takeaways from a pilot study?

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