CLINICAL TRIALS STARTUP PHASE: How to Identify Clinical Sites
Managing Clinical Studies is a challenging job and traditionally professionals use a numerous amount of tools in the startup process including, phone, fax, email and Excel spreadsheets.
The study startup process includes investigator initiation and submission of new investigator packages and it can become a time-consuming component of the clinical study process.
The clinical research community agrees with the following statement, “One of the most cumbersome and time consuming activities for anyone starting up a clinical trial is identifying high performing research sites.”
Clinicians agree that the startup process in clinical research is labor intensive, costly in terms of lost time and dollars, and is in need for improvement.
This is critical for research outcomes for a sponsor because these activities directly correlates to quick subject enrollment, attainment of overall enrollment goals, high quality data, fewer queries, and subject retention for any clinical study.
Pros and Cons of Common Methods Used to Identify Clinical Sites
Internal Database of Investigators
Sponsor and CROs usually manage internal databases of sites they have worked with in the past.
- Accessible sites
- Pre-populated sites
- Filtered Sites
- Long-term relationships with the sites
- Data base should be continuously updated
- Data base maintenance gets harder as the data base becomes larger
- Static data bases for new studies forces sponsors/CROs to look outside the data base
- New sites are needs all the time
Referrals or Key Opinion Leaders (KOLs)
Identifying a key opinion leader in a particular indication is also a common method used by sponsors and CROs to identify clinical sites. KOLs are usually professionals with firsthand knowledge and experience.
- Reliable information about the Clinical Site
- Updated insights about Clinical Research
- Knowledge and experience in particular indication
- They may not be available at the moment
- They may not conduct research
- They are usually hard to find or contact
CROs and SMOs
A Contract Research Organization (CRO) is an entity which works as a site identification organization. They usually work together with many Site Management Organizations (SMOs) which are networks of sites and investigators who offer the research service within a specific indication.
- They manage and update their own databases
- They offer a great option to delegate work
- They offer help in the startup process
- Investment cost are usually high
- They don’t usually work with your preselected sites
Sponsors usually use directories to identify sites to cast a wide net for site feasibility.
- Some of them are free of charge
- Offer a broader list of sites
- They are available online
- It’s difficult to know if they’re updated
- Still need to contact each site individually
There are plenty of methods to find the right sites for your clinical trials. What we can advise you to be aware of is the quality of the tools you, as a Sponsor are using. Principal Investigators (PIs) and Research sites will never be the same and the best option should be to delegate that extra job. There are people whose entire careers are on the move and providing the extra time to focus on research will be crucial and being able to delegate the startup process will help minimize time loss.