In today’s competitive drug development environment, there is an increasingly large demand for clinical trials, and for clinical trial sites to conduct this research. However, clinical research at site level is difficult. Sites face many challenges when it comes to studies – especially as clinical trial protocols become increasingly more complex and clinical trials are taking longer to complete. Added to this, clinical trials are often an additional responsibility to a site’s regular duties. This can lead to site staff frustration and burnout.
Understanding the clinical trial experience from the site perspective and then exploring ways to ease pain points and areas of burden are key to improving the clinical trial experience for site staff.
Top reasons for investigator dissatisfaction
A 2017 study showed that more than 50% of investigators who have carried out a clinical trial do not plan to do so again. Three main categories of reasons emerged:
We are going to drill down into some of the sub-areas of focus within these categories that will help you create a great site experience:
- Using communication to build a great site relationship
- Focusing on clinical trial management best practices to reduce the burden on sites
- Helping sites recruit and retain patients
- Optimizing clinical trial design to improve your trial success and site experience
- Considering technology that will ease site burden
- Building a stronger feedback loop with sites to assure current and future success
How to build a great site relationship with transparent communication
Many of the reported areas of investigator dissatisfaction are related to less-than-ideal communication. It’s not surprising that communication on any clinical trial is a challenge because of the many relationships that exist, including between the site and sponsor, as well as between the site and the CRO when there is one. At the site, there are many different roles, which may vary depending on the site, but could include:
Ensuring an efficient and transparent communication flow between all stakeholders is paramount in setting the stage for a successful clinical trial and minimizing impact on site staff. Here are some communication best practices that can help establish optimal communication before, during, and after the clinical trial.
Paying attention to sensitivities such as these goes a long way towards building a relationship built on mutual respect, transparency, and the feeling that sponsors, CROs, and the site are all working towards a common goal.
Clinical trial site management best practices
Optimizing site operations can improve the work environment for site staff, provide a better workload balance, and help reduce time burden on any one staff member. Here are some key best practices:
- Confirm adequate staffing levels so that the site team is not spread too thin. This will help the site feel prepared and equipped to carry out their roles. If needed, assisting with recruitment or providing short-term resources can help a site feel more confident about its role in the clinical trial.
- Provide a single repository for clinical trial information that is regularly updated and easily accessible to help insure that staff have the latest versions of documents, assure site compliance, and facilitate communication while providing a clear audit trail.
- Encourage real-time data analysis to be performed as the clinical trial proceeds. Real-time analysis allows sites to make improvements on a rolling basis while the clinical trial is in progress. J.P. Morgan suggests that analyzing clinical trial data in real time can “find commonalities across symptom progression and outcomes, improving success rates.”
- Support iterative improvement. Real-time analysis can also help identify pain points in the process, such as data that may be missing consistently across several patient records and point to possible solutions. In this case, maybe a different method is needed to collect or record this specific data point, to make it easier for site staff to obtain this information.
How to help clinical trial sites recruit and retain patients
Sites are under tremendous pressure to meet the enrollment targets they promised when agreeing to do a clinical trial. Knowing that this is a site pain point, it can be advantageous to help sites with this work by providing the following to assist with recruitment efforts:
- Assets and resources to be used in local recruitment
- Allocating a marketing and advertising budget
- Providing study-level recruitment initiatives
Once patients are recruited and a clinical trial is started, it can be a challenge to keep patients in the clinical trial – much of this is dependent on creating a positive patient experience. Sites feel the immediate pressure to improve the patient experience because of their regular contact with patients during visits. Here are some ways to help sites improve the patient experience:
- Simplify the consent process through animated patient education
- Provide a system for collecting patient data with a strong focus on the user interface
- Consider the accessibility of the clinical trial site for the patient population and adding more virtual visits
Clinical site staff are focused on increasing the safety and wellbeing of their patients. When patients are happy, sites are happy.
How clinical trial design affects your site and site staff
Good planning and thoughtful clinical trial design can improve the experience of site staff and help the clinical trial run more smoothly. Some clinical trial design tactics to consider:
- Prioritize clear communication at every stage of the clinical trial – critical when it comes to making changes, including clinical trial protocol amendments. Communicating enrollment targets and congratulating high performers can help focus minds on the study. Timely communication reduces site downtime and doubling of work for the site, for example, if a central lab was not receiving samples on a given day, etc.
- Plan for delays by building time into the clinical trial schedule – particularly useful to mitigate unexpected delays such as geopolitical events.
- Provide adequate and appropriate training for site staff – give them the basics, but try to provide what they need to carry out their responsibilities effectively.
- Streamline information provided to sites to include only the parts of the clinical trial that are relevant. This will make their job easier and can improve compliance with the clinical trial protocol.
- Deliver site training as close to the start of the clinical trial as possible so the information is fresh in people’s minds.
- Make training available online so site staff can quickly access and refresh their knowledge as needed throughout the clinical trial.
Technology that improves clinical trial site experience
Technology can be a huge help in mitigating investigator dissatisfaction with data and safety reporting by making it easier to collect data, and by providing ways to streamline safety reporting.
These features and more can be found as part of an integrated clinical trial management platform.
A clinical trial management platform provides many advantages to site staff including:
- Providing a 24/7 single repository for clinical trial documentation so sites can quickly and easily access the most up-to-date materials – arming them with the information they need to communicate clearly and effectively with patients and saving them time searching for materials with each patient visit
- Speeding up clinical trial conduct and reducing data collection burden by providing step-by-step instruction and making it easier to record patient consent, input data, update records, and assess outcomes
- Facilitating patient recruitment with features that can determine if sites have the patient population they need to meet recruitment goals
- Assisting patient retention by helping to ensure that patients are fully informed with features that support various aspects of patient education and information
- Offering innovative tools such as custom animations that can be shown to patients to educate them on their disease state, and how the drug used in the clinical trial will affect their body – making them feel more informed and reducing the time spent by staff doing this education with each patient
When selecting technology, ensuring that it is user-friendly will go further in reducing site staff burden.
How to create a stronger feedback loop with clinical trial sites
Once the clinical trial is complete, it is the perfect time to gain insight on how to make the site experience better for future clinical trials while also involving site staff in the process. This interaction helps the site staff feel as if their efforts on the clinical trial were valued and continues the transparent communication even after the clinical trial is complete. Here are some ways to create that valuable feedback loop with sites:
- Run focus groups with the site once the clinical trial is complete. A well-designed focus group can uncover many nuances of site experience and provide a sense of closure with the clinical trial.
- Conduct short one-on-one interviews with site staff to tap in to their experience and expertise. Examples include ideas about how to better retain patients or point out the limitations of the technology used to collect data.
- Gather and analyze key data. At the end of a trial, review the performance of each site against specific data points such as the number of protocol deviations noted and patients recruited and verify that this stood up to what they promised for feasibility, prescreening activities, compliance in training, and other areas. Using web-based clinical trial management tools can automate this data gathering.
- Survey and evaluate technology use. List what tools and resources were provided to sites to make their work on the trial easier. Evaluate – did they use those tools? Is there a correlation to usage of provided tools and better site performance on a site-by-site basis?
Taking the time to collect this feedback and have these interactions with sites can help uncover issues and provide sites with a sense of participation, input, and that their voice is being heard. It can also give them a greater sense of ownership of the study, and can help increase the positive perception of their experience.
Conclusion: How sponsors and CROs make happier clinical trial sites
By focusing on improving the site experience across areas such as relationship, communication, and optimal clinical trial management, and implementing processes and technology that can help sites perform clinical trial duties more efficiently, sponsors and CROs will see an increase in clinical trial efficiency and trial success rate. Site staff will benefit from a better work environment and a better experience on your clinical trials. In the long run, it’s a win-win – making a better environment for the sites, while meeting and exceeding sponsor clinical trial goals.
There is a better path to clinical trial success, and it starts with creating a great site experience. Learn more.