Clinical Trial Guidance for Sponsors: Four Critical Steps for Clinical Trial Success
As many seasoned clinical trial sponsors know, there are several factors that affect the outcome of a trial. While some of these factors are out of their control, there are a few fundamental elements we can control that greatly increase the efficiency and success of a trial if put in place early.
In this article, Chelsea Eckman, Director, Clinical Operations outlines four of these fundamental steps and why they are so critical to the outcome of a clinical trial.
1. Choose Partners Wisely
Consider the size of your trial and find an organization that will support your needs. Small and medium-sized contract research organizations (CROs) can often give more personalized attention, whereas a larger CRO may be able to provide a wider range of services. No matter which CRO you choose, try to meet the team that will be working on your trial as soon as possible. Most often, the higher-level executives or business development team you initially meet and work with is not the same team you will be working with throughout the life of the trial. Ask questions to find out how the team is structured. Most CROs will assign a primary project manager to your trial. Cultivate a relationship with your project manager and make sure you feel confident that he/she is a good fit because he/she will be the key person leading the team from the CRO side. The Clinical Research Associate (CRA) team will also be important, as they are the ones who will have daily contact with your participating sites. Ask how many Clinical Research Associates (CRAs) will be assigned to your trial and how the workload will be distributed amongst the CRA team. There are two common structures for a CRA team and advantages and disadvantages to both:
1) The 1-CRA Model: Some CROs will assign one CRA to manage each site. This CRA is the primary contact point for that site and handles all site questions, regulatory documents, and on-site monitoring. This model provides the site with a single point of communication, which can simplify the process for sites. However, this model can also lead to communication delays as CRAs are often traveling or monitoring at other clinical sites, and CRA burnout and frequent staff turnover can become problematic.
2) The 2-CRA Model: Other CROs will assign two CRAs to each site, an in-house CRA, and an on-site/traveling CRA. The in-house CRA is the site’s primary contact and handles most regulatory matters and day-to-day questions, while the on-site CRA travels to the site, provides in-person training, and conducts source data verification. This model helps ensure sites’ questions, and concerns are responded to promptly and consistently and distributes the workload to avoid burnout, so even if a trial lasts several years, the study team stays relatively constant. However, it does route site communication to two individuals, which can be confusing for sites until they are used to the model.
Regardless of which CRA model your CRO uses, try to learn what you can about their retention rate. High personnel retention at the CRO improves efficiency and helps build long-term partnerships so that the CRO remains a reliable link between the sponsor and the sites.
2. Establish a Solid Protocol
Make sure the clinical study protocol is clearly designed at the beginning of the trial to avoid excessive protocol amendments and save time. Bring in key opinion leaders and advisors to help design your protocol. If possible, ask one or two study coordinators at clinical sites to review your draft protocol to identify potential concerns with protocol assessments and visit schedule. A clear protocol will help improve site adherence, which is critical to data integrity and the resulting analysis. Keep in mind that all protocol amendments must go through IRB (Institutional Review Board) approval at each of your sites each time. This can potentially delay your timeline and cost more in IRB fees. Save time and money by ensuring your protocol is clear, concise, and consistent at the beginning of the trial.
Establish a clear communication plan at the beginning of the trial, including well-defined expectations and preferences for communication. For example, some sponsors like frequent phone calls, while others prefer weekly recaps over email. Communication should be clear and frequent, but not so constant that it floods your inbox.
Communication will be different during each stage of a clinical trial. During study start-up, the CRO is busy setting up study systems, processes, and plans. Expect more frequent communication in this early stage, and then weekly or bi-weekly calls between the CRO and the sponsor once the trial is underway. During the study maintenance phase, you can expect regular updates on site start-up, enrollment, data metrics, and any challenges the sites or CRO are facing.
4. Nurture the Relationship with Sites
If you are working with a CRO, lean on them for the day-to-day relationships with the sites. Keep this in mind when selecting a CRO—solid long-term relationships with sites can help your trial run as smoothly as possible. But do not forget that the sponsor should also have a relationship with the sites. It is a good idea for the sponsor to be involved during site initiation and check in directly with the sites periodically. This will help nurture the relationship with the sites, which can increase enrollment and efficiency. At Alira Health, our CRAs focus on establishing a positive relationship with the primary study coordinator and other key site staff who are working on the study. Showing appreciation for the site staff and being easily accessible for questions and concerns will go a long way in improving site productivity.
Every clinical trial, no matter how big or small, includes a lot of moving pieces for sponsors. Having a strong CRO, solid protocol, effective communication, and strong relationships will make the process more effective and will ensure everyone is on the same page every step of the way.
Chelsea joined Clinical Assistance Programs (CAP), a specialty CRO, in 2013 and joined Alira Health in February 2018 when CAP was acquired by the firm.
Chelsea has held several roles at CAP and Alira Health Clinical, including In-House Clinical Research Associate (CRA), Associate Project Manager, Project Manager, and most recently, Director of Clinical Operations. Chelsea has experience managing Phase I, II, and III clinical trials. She manages several vendors, including data management, safety, central laboratory, and drug distribution teams, along with the in-house CRA and Project Management teams. She is responsible for managing study details and timelines, relaying study updates and metrics to clients, and ensuring effective collaboration between all functional groups. Chelsea is a resource and escalation point for Project Managers and provides trial oversight and guidance where necessary.