Executing a clinical trial can be challenging even if the study itself looks good on paper. Once a protocol reaches a research site, the people responsible for conducting it often encounter requirements that weren’t obvious during development. Patients can face similar challenges when they have to coordinate study participation with their daily lives
The good news is that sponsors can address many of these issues before a trial even begins. Here are five things you can do to assist in those efforts.
- Establish clear communication with sites
Site teams shouldn’t have to navigate a maze of contacts to get answers to their clinical questions. When communication comes from multiple people without a clear point of contact, inquiries take longer to resolve and routine study work becomes harder to manage.
A dedicated medical affairs resource gives investigators a reliable place to turn when they need guidance. Ideally, this person should have the clinical expertise and be available when sites need support, including when teams are working in different time zones.
Building relationships is just as important. Investigators are more likely to engage with a medical affairs contact when they trust the person’s expertise and understand how they fit into the larger study team.
- Involve sites before finalizing trial protocols
Too often, sponsors don’t realize a protocol is difficult to execute until the study has already started, but it doesn’t have to be that way. With the right foundation in place, site personnel can identify potential problems before kickoff.
For example, a research coordinator might realize that frequent study visits will be difficult for patients who have to travel long distances. Or an investigator could recognize that a study procedure isn’t practical for the patients being recruited.
These perspectives make protocol development more grounded in clinical reality and can help sponsors make better decisions when selecting sites. The goal is to find sites that can realistically carry out the protocol and reach the right patients. At the same time, sponsors should consider whether a site has the staff and resources to support the study and whether its recruitment capabilities align with enrollment requirements.
- Look beyond your principal investigators
Principal investigators (PIs) are an important part of any clinical trial, but they aren’t necessarily responsible for the work that keeps the study moving forward each day. Research coordinators and other site personnel often manage much of the operational workload, and their familiarity with study documentation and protocol requirements can significantly affect how efficiently a trial runs.
Sponsors should therefore look at the entire site team when choosing study partners. An investigator may have lots of clinical experience but limited trial experience, while a well-trained research team can help make sure the study is carried out correctly.
It’s also important to know how involved the PI will be once a study begins. Experienced investigators may oversee several trials or have responsibilities at multiple institutions, which can limit how involved they are in the day-to-day work. For that reason, sponsors should define the PI’s role before selecting a trial site.
- Design protocols around patients
Patients have to fit clinical trial participation into their existing healthcare and daily lives. Study visits and other requirements can be challenging to manage alongside work, family responsibilities, and other demands on their time.
Even if a protocol looks reasonable during development, it can still create significant hurdles for participants once the study begins. A demanding visit schedule may be difficult for patients who have work or other responsibilities, and requiring participants to complete lengthy questionnaires or undergo multiple procedures during each checkup can add to that burden.
Patient input can help identify these issues earlier. Sponsors can gather feedback from patient groups during protocol development and use patient-reported outcomes to better understand how participants experience their disease and treatment. Gathering this type of information can lead to protocols that are more closely aligned with the people your study is designed to serve.
- Use technology to make things easier
Technology is another effective way to make trial participation and study management easier, but it’s important to be strategic about its use.
For example, a consolidated trial platform can reduce the number of systems site staff have to manage, digital communication can help medical affairs teams respond to investigator questions more consistently, and patient-facing tools such as telemedicine make participation easier for people who would otherwise struggle with frequent site visits.
Despite those advantages, sponsors must consider how each new technology will affect the people expected to use it. Adding another platform can create more work if your site staff have to learn how to use it or keep it up to date.
As you adopt new technology, data privacy and transparency should remain part of the conversation. Sponsors need to understand how a new tool will collect, store, and use clinical trial data, as well as whether its use meets ethics committee expectations and current GCP requirements. These insights take extra time and effort to gather, but they’re absolutely necessary.
Better execution starts before a trial begins
The challenges that affect trial execution often begin long before the first patient walks into a research site. Protocol development, site selection, and communication planning all influence what happens once a study is underway.
Sponsors who involve site personnel and patients in the early planning stages can identify potential barriers while there’s still time to address them. This approach gives clinical teams a stronger foundation for carrying out studies and helps keep the focus where it belongs: on conducting quality research for the patients who make it possible.
If you need help with any aspect of clinical trial management, our experienced team can help. To learn more about our capabilities, request a proposal today. Fill out our digital contact form.