Handling study objections: Part 1
Representatives who execute these suggestions may soon be rewarded with a physician’s objections to the clinical study they’ve presented. I say “reward” because when you engage physicians in a meaningful dialogue, an objection gives you more information on the factors they consider when making decisions than enthusiastic head-nodding (which may just mean they want you out of their office as soon as possible).
Now that your physician has taken the time and effort to disagree with you — perhaps rigorously — about the clinical study you just presented, what should your next steps be? Here are four steps you don’t want to take:
D — defend.
E — extrapolate.
A — assume.
F — make false comparisons.
These behaviors are what I call acting DEAF to customers (I have written about this elsewhere: “Art of Medical Science Liaising,” August 1, 2005, www.mslinstitute.com). Each mistake is all too easy to make, especially when we feel a discussion is wandering beyond our control.
Don’t defend the study
The fastest way to invite hostility is to defend the study, because in essence, this implies that the physician was wrong in his objections. Here is an example of an objection with a few possible responses:
Doctor: This data is not significant. The p value is 0.3.
Representative (response one): But here it says the data has a favorable trend.
Diagnosis: Bad response. The representative discounts the doctor’s objection by presenting a weak defense that invites an objection about the study design and accusations of statistical manipulation.
Representative (response two): You’re right, it is not statistically significant. What do you think about the claim of a favorable trend?
Diagnosis: Better response. The representative does not defend against the doctor’s objection. However, the representative is asking a question that can still invite objections about study design and statistical manipulation.
Representative (response three): You’re right, it is not statistically significant. Based on this data, what would you conclude about the utility of this drug?
Diagnosis: Best response. The representative does not defend against the doctor’s objections or redirect the doctor. Instead, the representative asks a question that invites the doctor to share how he interprets the data.
Objections that ensnare representatives into defending the study include questions about the study design, patient population or sample size, statistical significance, and statistical versus clinical significance.
Don’t extrapolate
When I was a sales representative, one of my products was an antidepressant. Those of you in neuroscience can appreciate how notoriously difficult cause-and-effect relationships are to pin down in the nervous system. Consider what happened when I tried to extrapolate results from basic scientific concepts:
Jane: Doctor, this drug binds this receptor and acts on that receptor, and it would likely have this effect. What have you seen in your clinical practice?
Doctor: Well, I see [something different from Jane's expectations].
Jane: But this drug binds here; wouldn’t you theoretically see this?
Doctor: Yes, theoretically.
This scenario shows an extrapolation from the theoretical to the clinical. Other extrapolation danger zones include portraying clinical study results from a small number of patients as applicable to entire patient populations and drawing imaginary “efficacy lines” from interim study results (despite the possibility that an interim trend may ultimately plateau and the study may not meet its primary endpoint).
When you are describing a clinical study with a small patient population, you can gain more credibility by pointing out that the results are based on a small sample size and therefore no conclusion can be drawn to a representative patient group. This may seem counterintuitive, because companies are likely to prepare us to defend our study against misinformation spread by the competition. Present key parts of a clinical study in a balanced manner, and invite physicians to interpret the study’s relevance for themselves. This takes the stress out of constantly being put on the defensive, lets you enjoy the scientific dialogue and ensures that your products are used on the right patients.
My next column will tackle assumptions and false comparisons.
{ 1 comment… read it below or add one }
I found this information interesting and very applicable. could you direct me to Part 2 and any other follow on parts.
-Barbara