Welcome to the third installment of this series! The goal of each article in this series is to improve the quality of all clinical trials by reminding you, the reader, of another important step that will increase the likelihood that your next study will be completed on time, within budget, and with a minimum of complications.
Unfortunately, few studies reach this goal. Instead, they suffer significant delays, mediocre communication, sloppy data, ineligible subjects, cost overruns, and numerous protocol deviations. But why? I believe that the problem is one of focus…not a lack of focus, but a misdirected one. Too many in our industry put blind faith in experience and effort. They forget that experience matters only if it delivers the results you want. Otherwise, that so-called “experience” is nothing more than an accumulation of bad habits. And effort matters only if it is efficient and effective. Otherwise, all that energy is wasted. In other words, to be successful, we must focus first (and always) on what we want. The results we want dictate not only what we do, but also (and more importantly) how we do it.
First, a quick review:
Tip #1. Clear Expectations. One of the most effective ways to prevent problems during a clinical trial is to set clear expectations for all study project team members before the study even begins.
Tip #2. Comprehensive Planning. Planning for each phase of the clinical trial must involve all members of the project team and be comprehensive, detailed, and unambiguous.
Now, on to Tip #3: Effective Investigators. Notice the adjective “effective.” That was intentional because, while every investigator may be a good veterinarian, not every veterinarian makes a good investigator. Some veterinarians are enamored of the idea of participating in clinical trials but quickly tire of the rigor. Others have participated in clinical trials in the past and, therefore, “know it all.” Still others are in it solely for the money and will cut corners whenever and wherever possible. None of these will be effective investigators.
According to VICH GL9 Guidance for Industry, Good Clinical Practice, the investigator is responsible for all aspects of the conduct of a study at a study site. That includes “…the dispensing and the administration of the investigational and control veterinary product(s), the implementation of the study protocol, the collection and reporting of the study data, and the protection of the health and welfare of the personnel involved in the study and the animals during the study.”
That’s a pretty tall order. So, how do you find effective investigators? Years ago, I used to cold-call veterinarians around the country and interview them over the phone. Those who boasted about the many trials they had completed or first wanted to know how much they would be paid quickly fell off my list. Those who asked thoughtful questions and requested a copy of the protocol before committing piqued my interest. Site visits helped me assess each veterinarian’s management and organizational skills, their staff’s professionalism and attentiveness, their level of caring for their clients’ pets, and their clinic’s layout and equipment. The final step was a frank discussion of the protocol’s requirements, the study timeline, and the veterinarian’s ability and willingness to allocate the necessary time and staff. In the end, though, it came down to gut feel.
Did I always get it right? Of course not. And neither will you. We all have met veterinarians who are great at self-promotion but not so great at following protocols. No matter; with each new candidate, you will ask better questions, be more skeptical of quick answers, and look deeper during site inspections to increase the chance that your final selections will be the stellar investigators you need.
So, now you have enough investigators for your upcoming study. Whew! Alas, assembling a roster of effective investigators does not end with the “picking.” By selecting a veterinarian to be an investigator in your next clinical trial you are starting a relationship. And, like all relationships, this one needs work…lots of work…from both sides. I already have mentioned the myriad responsibilities of the investigator. Now, let’s talk about the sponsor’s or CRO’s half of the deal.
A very large part of an investigator’s effectiveness depends on their understanding of the protocol and study design. Just sending an investigator a copy of the protocol and expecting them to produce good study results is worse than wishful thinking. Don’t laugh. I have encountered situations in which that very thing happened. In fact, for one study, several different versions of the protocol were in use at various sites. Imagine the nightmare of reviewing that data!
If you want good study results, there is no substitute for thorough training of each investigator and all of their participating site staff. Study training can be centralized, on site, or webinar-based, but it must be comprehensive, interactive, and rigorous. Stealing a phrase from the IT world, this is another case of “garbage in, garbage out.” If you expect complete, accurate, and error-free data, then your training program must be complete, detailed, and exacting. You can have the smartest, most willing veterinarians in the world but, if they do not know precisely what to do and how to do it (as well as what not to do), they cannot deliver the high-quality results you want.
Some project teams are pretty good at selecting investigators, and they also do a decent job of training the sites. But then the data start rolling in and they get bogged down and distracted. Remember the relationship analogy. If an investigator is to be truly effective, they will need a lot of nurturing and support. Make sure that they have the latest version of the protocol. Train them on every amendment. Be available for their questions. Keep them supplied with investigational product and case report forms. Visit their site regularly to confirm that all is well. Provide remedial instruction when warranted. If the investigator knows that you care about them and their performance, they will care about your study.
This high level of attention increases the odds that site performance will meet your expectations. It also increases the likelihood that serious problems will be discovered before they scuttle your study. No one likes to talk about ineligible subjects, fabricated data, lost investigational product, forged investigator signatures, and fake lab results but, regrettably, they do occur. Extensive site training, strong investigator support, and vigilant monitoring will help prevent most such problems and catch the rest, make your investigators as effective as they can be, and help ensure that your next study is a resounding success!
The next article in this series delves more deeply into study training and the importance of a solid understanding of the protocol and study design to the ultimate success of your next study. I hope you’ll join me!
In the meantime, please let me know your thoughts, comments, and suggestions regarding these tips…or the clinical trial process in general…and how we, together, might make it better for all of us.