Pharmaceutical companies say so, but doctors listen like that?

I believe no one can deny that the pharmaceutical industry is a high-tech industry

When the entire industry has focused its attention and capital on the above-mentioned disciplines (mostly natural sciences), the FDA, as a global leader in regulatory science, conducted an interesting study to remind pharmaceutical practitioners to pay attention to a relatively unpopular field

The study, "Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion ," was sponsored by the FDA's Office of Prescription Drug Promotion.

Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion

A study, and a potentially life-threatening and valuable question

A study, and a potentially life-threatening and valuable question

Doctors often receive marketing materials for oncology drugs from pharmaceutical companies, which usually include various preliminary or exploratory clinical data

Sounds innocuous, so let’s put it another way: How does this data influence doctors’ decisions when prescribing?

How does this data influence doctors' decisions when prescribing?

This issue may be life-threatening for patients; for pharmaceutical companies, it can be said to be invaluable, so it is also crucial for FDA supervision

However, this is by no means a question that a study can answer, and we come back to this study

FDA researchers read a lot of relevant literature in advance and sorted out some conclusions such as the following:

- Initial or exploratory clinical data in drug promotion materials, usually selectively extracted , may exaggerate drug efficacy if not viewed in context

- Initial or exploratory clinical data in drug promotion materials, usually selectively extracted

——Doctors are usually very confident that their prescribing behavior will never be influenced by promotional words ; however, doctors are human beings after all, and studies have shown that medical experts, like decision makers in any other industry, are susceptible to perception The impact of cognitive biases

- Doctors are usually very confident that their prescribing behavior will never be influenced by promotional talk

- When used properly, data display techniques can be powerful tools to help physicians better understand clinical trial results

- When used properly, data display techniques can be powerful tools to help physicians better understand clinical trial results

If the limitations of clinical data (including methodological limitations and practical limitations) are disclosed in drug promotion materials, and the drug has "uncertain clinical value", will it help doctors to interpret clinical data more accurately and effectively? Woolen cloth?

If the limitations of clinical data (including methodological limitations and practical limitations) are disclosed in drug promotion materials, and the drug has "uncertain clinical value", will it help doctors to interpret clinical data more accurately and effectively? Woolen cloth?

Experimental Design: Promotional Materials Based on Real Products

Experimental Design: Promotional Materials Based on Real Products

The study used a design of 2 experimental groups (variable 1) crossed with 2 experimental groups (variable 2), plus 1 control group

Among them, variable 1 is the disclosure method of "clinical data limitations", which is divided into "technical disclosure" (technical) and "nontechnical disclosure" (nontechnical).

Variable 2 is the disclosure of "uncertainty of clinical value", ie "present" and "absent"

The control group was "no disclosure", that is, neither variable 1 or 2 above was involved

A total of 1531 doctors were recruited as subjects in the trial, and the promotion materials based on actual reference drugs were used to carry out the trial simultaneously in 3 groups.

The translation of the above table is mainly used to understand the results and conclusions that follow

The questionnaire design, data statistics and analysis of the test are omitted here.
Interested users who know the forest can go to the following address to check the original text:

https://theoncologist.
onlinelibrary.
wiley.
com/doi/10.
1002/onco.
13972

Test results: Doctors' answers after interpreting promotional materials

Test results: Doctors' answers after interpreting promotional materials

- An understanding of the analysis, results and limitations of clinical data

- An understanding of the analysis, results and limitations of clinical data

On average, doctors answered about half of the comprehension test questions correctly
.
Among them, doctors who read the "limitation of clinical data" content were more accurate than the control group
.
The researchers believe that the results support the FDA's recommendation that while providing visual data, it is also possible to disclose relevant background information to inform the limitations of the analysis and results, which is more helpful for doctors to understand the data, rather than hindering it.
or distorted
.

half

- Judgment of the claimed clinical value of the drug

- Judgment of the claimed clinical value of the drug

31.
0%-56.
0% of doctors correctly judged that the data in the promotional materials are not enough to translate into clinical efficacy
.
Among them, in Trial 1 and Trial 3, the content of “clinical data limitations” disclosed to doctors did not affect their judgment of “clinical value”
.
In other words, pharmaceutical companies deliberately "mask" some limited information that is unfavorable to the data, which may not be effective
.

In other words, pharmaceutical companies deliberately "mask" some limited information that is unfavorable to the data, which may not be effective
.

- perception of the strength of the evidence

- perception of the strength of the evidence

In the three groups of trials, 10.
7%-33.
3% of doctors mistakenly believed that the promotional materials provided strong evidence for the efficacy of the drug
.
Although physicians who read the words "uncertain clinical value" tended to think the evidence was insufficient, there was no difference compared to the control group
.
That is, promotional materials had no significant effect on physicians' perceptions of the strength of the evidence
.

Promotional materials had no significant effect on physicians' perceptions of the strength of the evidence
.

- Awareness of the benefits of the drug

- Awareness of the benefits of the drug

On average, based on limited information in promotional materials, physicians tend to believe that patients will gain some benefit from the drug
.
At the same time, the researchers also found that even disclosing "uncertain clinical value" or "clinical data limitations" to doctors did not affect people's perception of drug benefits , whether positive or negative
.

Does not affect people's perception of the benefits of the drug

- Awareness of progression to clinical endpoints

- Awareness of progression to clinical endpoints

On average, physicians tended to agree that the drug contributed to the progression of clinical endpoints
.
Not surprisingly, fewer physicians who had read the "clinical data limitations" material held this view than the control group
.

- Preference for "non-technical" or "technical" disclosures

- Preference for "non-technical" or "technical" disclosures

Across the three trial groups, most physicians preferred "non-technical" explicit disclosures
.
As in Trial 2, although the results presented by the KM (Kaplan-Meier) curves are from a statistically insignificant interim OS (overall survival) analysis, it is because of the addition of a sentence: "So far it is not possible to draw Conclusion of OS benefit”, the physicians in Trial 2 had relatively weak perception of the benefit of the drug
.
A concise and straightforward statement of conclusion is more effective than just a bunch of data
.

A concise and straightforward statement of conclusion is more effective than just a bunch of data
.

The same conclusion, how does the FDA use it, and how does the pharmaceutical company use it?

The same conclusion, how does the FDA use it, and how does the pharmaceutical company use it?

The FDA concluded from this study that "inadequate recognition of 'clinical data limitations' can lead to misinterpretation of clinical value.
.
.
Disclosure of this information is likely to contribute to greater clarity understand the data
.
”

The FDA is a regulatory agency after all
.
As a result, "FDA can provide best practice recommendations based on this conclusion, (requiring pharmaceutical companies) to include corresponding disclosures in promotional materials to help (doctors and patients) obtain more accurate information .
.
.
Pharmaceutical companies also These conclusions can be used to better conduct compliance efforts, particularly the requirements for promoting disclosure in 21 USC 352[a]; 21 USC 352[c]; 21 USC 321[n]
.
”

But are pharmaceutical companies just thinking about "compliance"?

Numerous social science experiments (though often not considered "exact science") point to the fact that people, regardless of education level or status, are subject to some degree of cognitive bias, Thus influencing its decision-making, which includes politicians, judges, teachers, lawyers, voters, and of course doctors, drug reviewers, GMP inspectors
.

Going back to the big question, how does it influence doctors' prescribing decisions?

How does it affect doctors' prescribing decisions?

China has made great strides towards the era of pharmaceutical innovation, and the answers that "worked well" in the past are increasingly unworkable
.
Responsible pharmaceutical companies may be able to look at this issue from a more scientific point of view, and truly put equal emphasis on "academic" and "promotion", based on accurate, complete and reliable data, and use scientific-based information communication to help Physicians gain unbiased perceptions
.