A CRO always looks for quality investigators. They are the key to fulfilling the CRO's contract requirements that has come their way and they want to do a darn good job. So do the good investigators, of course. It makes sense for everyone involved including the sponsor. We at ClinSmart have been in all three roles in our respective careers and can vouch for the validity of these facts. So let me tell you what I look for when I'm selecting a principal investigators for a clinical trial we have a contract to fulfill.
1. Specialty in the field of study.
This is an obvious point but a critical one; we must determine that the principal investigator really knows the special field and has had experience with those patients. The investigator has knowledge and judgment about the patients, the disease progress and the potential pitfalls of treatment. The investigator often must make judgments re: disease effect versus possible adverse effects that may be associated with the drug.
2. Experience and familiarity with FDA requirements for clinical trial investigations.
Quite appropriately, there are a number of regulations guiding the conduct of clinical trials. All of them have a rational basis that led to their creation, often times not obvious to the sponsor nor the CRO. Adherence to the regulations is vital since all trial data will be submitted eventually to the FDA where their experts review it in detail. This review is important not only for efficacy but safety criteria equally as well.
3. Compulsiveness in following the protocol.
This is a must. The CRO will routinely audit the data entered in case report forms that ultimately is accumulated and analyzed for the clinical trial report. These reports are not only reviewed by FDA experts but their statistical group will run their own analysis for the results. So the data must be accurate and complete. An investigator who is compulsive in their own practice will very likely be compulsive in the trial data.
4. Adequate and appropriate staff.
Conducting clinical trials is not easy and virtually impossible to conduct without an adequate staff. An experienced clinical coordinator is just as important, maybe more so, than the investigator herself. So we always want to meet with the coordinator and the rest of the staff.
5. Adequate space and facilities.
Besides the customary privacy accorded any patient, we must be mindful of potential interactions among enrolled patients, especially when patient judgments re symptom scores, etc. are a critical part of efficacy measurements for the study. When patient are able to intermingle, they often will chatter re their own experience and may influence follow subjects' scoring numbers. This is not necessarily true for every trial, but it is one the considerations sometimes when selecting a site and investigator.
6. Honesty is a given.
It is presumed that a principal investigator is naturally honest and it is assumed so. However, there have been rare occasions when an investigator has cheated. Let me tell you, it is a very serious offense and leads to numerous problems for the investigator, the CRO and the sponsor.
These are some of the qualities we look for in selecting a principal investigator. The proper conduct of clinical drug trials is a very serious business and we want quality, quality, quality in every respect and throughout the trial.