Things to Consider When Creating a Clinical Trial Protocol

Designing a clinical trial protocol is a tedious process for any organization. Here are some of the strategies to keep in mind while writing a protocol – and pitfalls to avoid.

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When creating a clinical trial, you want to design a process ensuring both the safety of each person participating and the reliability of the data you collect. This is why a well-written clinical trial protocol is so integral to the development and successful execution of a study.

In order to write a protocol that sets your trial up for success, there are several considerations to bear in mind, including collection restrictions, ways to avoid issuing clarifications, and employing strategies to save time and money in the midst of a trial.

Read More About Clinical Trial Design Best Practices

Common Issues with Collection Restrictions

Most often, laboratories will experience challenges with organizations that submit volume-related restrictions in their protocol without consulting with the laboratories that will be processing the samples. If the total number of tests required ends up being greater than what is allowed by the lab, the discrepancy could create delays. Having a conversation with the lab beforehand is a good way to avoid this issue.

Exploratory samples are another common issue to be mindful of. If an organization writes into their protocol that they want to collect exploratory samples, but does not designate in advance what those samples will be used for, that can lead to confusion and potential delays in the future – especially if the lab processing those samples ends up not having the capabilities to do so. The more specific an organization is about its collection methods, the less confusion there is down the road.

Avoiding Clarifications or Amendments

Careful scrutiny of a clinical trial protocol is vital to avoiding confusion later in the trial. If conflicting directives are put into the protocol, this can lead to confusion and eventually the potential need to issue a clarification letter.

For example, if an item is listed as an inclusion or exclusion requirement, but is not listed in the schedule of assessments, this will need to be explained.

A clarification letter (sometimes called a note to file) will serve as an appendix to help clarify an unclear or incomplete portion in the protocol. This is seen as a simpler alternative to an amendment, which involves notifying the FDA and institutional review boards where trials are being conducted. Amendments can be expensive, cumbersome and time consuming.

“The more detail that goes into writing the protocol, the better,” said Jennifer Fox, PhD, Associate Director for Project Management at ACM Global Laboratories. “Sometimes protocols can be contradictory. That is one of the most difficult things to resolve after a trial begins – either vague or conflicting information.”

Consultation with industry experts in the early stages of a clinical trial protocol can help to ensure the safety and efficacy throughout the entire process.

Potential Consequences

Any adjustments made during the trial have the potential to affect the process in two significant ways: added time and added cost. For small to mid-size companies running clinical trials, these can be especially taxing.

Making amendments or clarifications mid-trial can also cause problems with data inconsistency. Sponsors may need to add patients to the trial to ensure proper statistical analysis when the results of the study are brought to regulators.

When sponsors running a multi-site study are unable to roll out a clarification or amended version of the protocol universally, this makes the study harder to manage. Different versions of the study may be running at different times, samples may be collected at different times, and varying levels of supplies may be needed. If all patients are not operating in the same way, it makes it more complicated and difficult to maintain the integrity of the data.

A Key Time-Saving Strategy

One approach to keep the trial on track is ensuring the involvement of different stakeholders in the project, starting from the early stages. This means including the core study team, scientific advisers, and any vendors from the very beginning.

More collaboration in the planning process makes execution of the trial more cohesive on all levels.

“The more engagement and involvement stakeholders can have in the protocol process, the greater potential for success,” said Daniel Heizyk, Director of Study Startup at ACM Global Laboratories. “If vendors become familiar with the protocol early on, they can help avoid potential challenges.”

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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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