Earlier this week a piece was published in the Annals of Neurology reporting how certain authors are on clinical trials and implying that they could be "guest authors"; celebrated “key opinion leaders” who do not contribute to trial design or execution, or manuscript drafting, but whose name lends gravitas to the study.
Today Prof A gives a response to this.
First I must say that Prof A is from Canada and is not the "Guest Author A" in the piece by Prof C.
It has been said that I was too critical in the critique so I'll keep my mouth shut but, here is an alternative view
According to Prof A:
"Stated in the editorial is that of 10 individuals considered to fall into this category “all
are clinical neurologists; none have particularly rare skill sets”. Although not specifically named,
the individuals placed in this category can readily be recognized".
"A review of their overall accomplishments
indicates that indeed they do have distinct skillsets that underlie why they have
been repeatedly selected for the trials cited"
"Most of the selected individuals are widely recognized for contributions to the MS field that extend
far beyond their role in commercial based clinical trials. They have developed large multidiscipline
MS centers that have carried out combinations of clinical, imaging, and basic biology
based studies that have contributed significantly to our understanding of the MS disease process".
"Their “non-commercial” contributions can be found in major academic journals and include
investigator initiated trials with non-commercial agents. They have been recognized within
their own institutions for major leadership roles".
"They have been repeatedly invited to international
congresses and symposia and serve, usually voluntarily, on panels established by governmental and not-for-profit disease agencies that allocate major resources for MS patient care and research".
"Their involvement with multiple studies provides a broad perspective on the
MS therapeutic landscape".
"Further noted is that these individuals are amongst those most frequently
selected by the academic journals to referee studies and provide commentaries and
reviews. Such selectivity would also apply to the academic basic sciences where key opinion"
"Perhaps we under-appreciate what special skillsets these individuals
do have. A review of registered clinical trials that were not successfully completed indicates
the importance of selecting key individuals who can deliver"
"As multiple disease directed
therapies have come available and as the straight forward placebo-controlled trial has
become no longer feasible, it unlikely that that pivotal trials would be successfully executed
without clinical experts contributing to trial design or execution".
" The individuals cited could
readily document the time (even if compensated) that they have devoted to the design and reporting
of these trials, acknowledging that this done in concert with the sponsor"
"The large clinical trials also include authors who have recruited large patient numbers;
the effort and skill involved in running effective MS centers should not be undervalued."
" Subsequent secondary analyses
have been reported for most of the approved agents in a range of peer- reviewed journals.
Opinions and reviews regarding specific agents are also presented in non- reviewed publications
directed at the professional community"
"Concerns in these areas include the involvement of commercial writing companies
in compiling and recording the data to be presented."
"Perhaps writers and presenters should be
limited to those who played an active role in the design and oversight of such ongoing trials. A
similar critique could be raised for the many more local presentations given by industry selected
"Further raised in the [Prof C] editorial is the interests of the clinical trial leaders in promoting MS
professional organizations in which they are involved, specifically ECTRIMS and ACTRIMS".
Prof A is the president of ACTRIMS, an organization that partners
with ECTRIMS to hold a joint meeting every 3 years and also has its own annual conference,
"Although industry influences need to be acknowledged including their on-site
presence, these venues have become major go-to sites for dissemination of MS clinical and research
The ACTRIMS board of directors and scientific committee are wholly responsible for the programme.
"Any symposia presented by industry
are specifically identified"
"ACTRIMS underwrites the attendance at its annual Forum of trainees from all American
and Canadian approved neurology programs, and presents a specific program for them. We aim
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to contribute to development of a new generation of individuals who have expertise to drive
clinical investigations and trials, perhaps addressing the issue that the limited number of leaders
reflects a failure to train those with such expertise."
"One can readily agree with [Prof C] that we can improve the on the current means of designing
and reporting of commercial clinical trials (and the dissemination of subsequent information).... One
commends him for drawing to attention the challenges of clinical trial design and data reporting
and we both look forward to emergence of a new generation of clinical leaders who will take up
Do you agree?
Labels: Team G News