By Ray Tobey, Chief Medical Officer on Jun 14, 2017 9:56:40 PM
When starting a clinical trial for an investigative drug, one of the most critical steps for the CRO is the selection of investigators. Here are the characteristics we look for in this process.
1. Past Success
For the most part, a CRO that has been active for a period of years has considerable experience with a list of excellent investigator sites. That is a good starting point. Occasionally one has not performed well. Not good.
2. The Quality of Data Collected in Previous Studies
Next, we want to look at the quality of the data collected in previous studies, if possible. The extraordinary compulsiveness required for data collection is paramount for a successful trial. The principal investigator sets the tone for this compulsiveness that is then carried out by his/her staff led by the research coordinator. It is just as important to know that person as well as the principal investigator. Every detail matters.
3. Access to the Designated Patient Population
A center within an area and season where the disease condition is common is obvious. For example, no sense planning an allergic rhinitis ragweed study where ragweed doesn't grow or before or after the rather consistent time of ragweed pollination.
4. Dedication of the Investigator and the Staff
Evaluating this characteristic is done through past records or solid referrals. It is so frustrating for a CRO to be promised active recruiting of subjects and then learn that it is not a priority for the investigator center.
5. A Collegial Atmosphere Among the Investigator Staff
The team that gets on well together usually works well together. Old but true characteristic. And the CRO is part of that same team! So we want to work well too.
6. Honesty, Honesty, Honesty.
We must have a trust with the investigator and the staff, and they with us. Glitches do happen but almost always can be worked out effectively if addressed properly.
7. Recruiting Subject Enrollees in a Timely Fashion
The act of doing so requires serious thoughtfulness and a stick-to-it attitude. The principal investigator is the lead in this along with the research coordinator. We look for those characteristics.
8. No Conflicts of Interest with Other Trials
Regarding subject enrollment capabilities, a previously used investigator site with outstanding enrollment success may not be a good choice for another study if it is already involved in enrolling the same subjects for a currently ongoing study. For example, if we’re doing a study for a particular cancer and the site is already engaged with another sponsor, it is clearly a conflict for a site to recruit for two studies with similar entrance/exclusion criteria.
9. Only If New Sites Are Balanced with the Old
How about a new site? Yes, it's ok if all the personal characteristics are good and an energetic investigator wants to start up. But we would probably only use such a new site among other experienced sites.
10. Already Has a New Drug or Device That Will Be In Market Soon
A very real positive for the site is the experience the investigator and the team gets with a new drug or device that will likely be in the marketplace soon. It keeps you up to date on conditions within your practice, even ahead of time. A new trial can be very interesting for all involved!