One of the aspects our teams do really well at Trial Runners is getting a study up and running fast. We average about 55 days to first patient enrolled after the clinical protocol is finalized. Executing a successful study start-up quickly is an essential first step in the life cycle of a clinical research trial and lots of credit goes to our ability to work with Central IRBs. Being able to utilize a Central IRB can save weeks and sometimes months to the start-up process.
In clinical research, an institutional review board (IRB) is the committee responsible for ensuring the safety and protection of human subjects participating in a study. The primary roles of an IRB are:
- Review and approve the clinical study protocol
- Review and approve the patient informed consent form
- Review and approve any marketing materials involving potential patients (advertisements, etc)
- Review all Adverse Event and Serious Adverse Event reports
- Participate in the authority to open and close clinical sites in a study
What is the key difference between a central IRB and a local IRB?
- A Central IRB is the IRB provides the ethical review for all sites participating in a multi-site study.
- A local IRB provides the ethical review for one site participating in a multi-site study.
A central IRB has board reviews every day as opposed to sometimes monthly for local IRBs. The turnaround time for central IRBs is one week, which really turns up the speed on getting sites ready to start a study. Trial Runners is passionate about meeting timelines and in an industry that more than ever fails to meet timelines, we look to get an edge wherever we can. Using a central IRB helps us accomplish that goal.
Of course, there are times when a study must include the use of local IRBs. Outside the United States there are local ethics committees which means proper planning around timelines needs to take place when including multiple countries. Even if a small portion of sites require the use of a local IRB in a study, the start-up timeline isn’t compromised too much, so don’t panic if you need to include a few in a study. Academic institutions and hospitals usually require the use of their own IRBs and we can’t blame them for wanting to have full confidence and control over the safety of patients engaged in their clinical trials. In recent years, we have seen some of these institutions allow the use of a central IRB in their studies, so we will keep our eye on what the impact of those experiences will mean for the future.
What we find most beneficial when using a central IRB is that we can establish a strong working relationship across many studies. We have used the same central IRB (Sterling IRB), for the past 12 years and this commitment together yields an incredible upside for studies. The Trial Runners team knows exactly what our central IRB wants and can communicate that both internally and to the participating sites in a study. Across both teams, there is a strong level of comfort and rapport which means things are going to go way smoother than normal which leads to faster timelines and cost savings.
If you want to contribute to solutions towards better odds at meeting your timelines, you should consider using a central IRB for your studies. To go a step further, I would suggest finding the right central IRB to work with and stick with them over the long haul. Do the hard work of identifying their process, performance metrics and turnover. If each of those elements are where you want them to be, then it is worth your while to cultivate this relationship over the long haul. It has helped us tremendously with our start-up metrics and can do the same for you.