There are many factors that go into a successful clinical study start-up. Having the proper team assembled can be a critical factor in the success of any study. Choosing the right site is another factor that can make or break a successful study start-up. Having a research coordinator and principal investigator that are engaged is important too.
The clinical study and planning team should ideally consist of the following members:
- The Sponsor
- The study site staff that will conduct the study (Principal investigator, research coordinator)
- The legal and contracts teams
- The institutional review boards (IRB) or ethics committees
There are deliverables from each team member that need to be met. From the sponsor a final protocol should be delivered before the investigator meeting. How many times are studies delayed because the draft protocol needs to be revised? This in turn can cause contracts to be renegotiated. This can cause further delays in contract reviews with both the budget teams and the legal teams from both the site and sponsor. If the protocol is in the draft state how can the IRB approve it when they know it will be changing?
For a study to be successful the site selection is critical. Having a principal investigator and research coordinator that are engaged is important. Along with a “plugged-in” team, experience is another important trait. According to the NCBI (National Center for Biotechnology Information) there is a work force shortage of qualified clinical research associates, clinical research coordinators and principal investigators. This can mean that there is a lot of competition for limited resources.
Legal and Contract Teams
Often times the legal and contract teams have limited scientific or medical experience and do not understand the nuances of clinical research. A change in members of the team can delay contracts, which in turn delays the timelines that the sponsor is looking for to start the study. Patent times for a product can be limited and time is money!
Submissions to the IRB need to be carried out in a timely manner and as near to complete as possible so that once IRB approval is received the site study team can start enrolling patients. In the medical device field, waiting for qualified patients for enrollment is critical. It can take years to complete enrollment. It is in this area that having qualified experienced members of the study start-up team is crucial.
What has been your experience with study start-up? Share your thoughts below.