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Correspondence: Nirmala Bhoo-Pathy, Jean-Philippe Pignol, Helena M Verkooijen
Correspondence: Nirmala Bhoo-Pathy, Jean-Philippe Pignol, Helena M Verkooijen
Correspondence: Nirmala Bhoo-Pathy, Jean-Philippe Pignol, Helena M Verkooijen
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*Nirmala Bhoo-Pathy,
Jean-Philippe Pignol,
Helena M Verkooijen
ovenjjay@gmail.com
Julius Centre University of Malaya, Faculty of Medicine,
50603 Kuala Lumpur, Malaysia (NB-P); Department of
Radiation Oncology, Erasmus MC Cancer Institute,
Netherlands (J-PP); and Imaging Division, University
Medical Center Utrecht, Utrecht, Netherlands (HMV)
1
Authors reply
Our meta-analysis 1 of individual
patient data from trials in women
given mastectomy and axillary
clearance to at least level ll showed
that radiotherapy reduced mortality
from breast cancer by 20% in women
with one to three positive lymph
nodes (rate ratio [RR], irradiated
vs not, 080, 95% CI 067095;
2p=001) and by 13% in women with
at least four positive lymph nodes
(RR 087, 95% CI 077099; 2p=004).
Little reason of how radiotherapy
works exists to think that this
treatment for breast cancer has any
appreciable abscopal effect and so,
as Ismail Jatoi suggests, these results1
showed that a proportion of the
deaths avoided by radiotherapy would
have arisen from cells localised within
the areas targeted by radiotherapy
(ie, the chest wall and, for most trials,
the regional lymph nodes).
We agree with Rajni Sethi and
colleagues that doctors who use these
results1 in clinical practice need to take
Correspondence
EMAs transparency
seems to be opaque
The European Medicines Agency (EMA)
has now adopted its policy about
access to clinical trial data,1 more than
a year after the release of the rst draft
for public consultation.2 Although
intended to boost accountability
and trust in medical research, the
policy does not seem to meet such
expectations. 3 The main concern
is with respect to which data and
documents can be accessed. The policy
applies only to dossiers submitted
through the centralised procedures
from 2015. Pharmacovigilance
data are not deemed in the policy.
Before publication, the holder of
marketing authorisation could edit
clinical overviews, study summaries,
and reports to delete commercially
confidential informationdisclosure
of such information might undermine
a companys economic interest.
This redaction process could be
assumed to only apply to trade
secrets (eg, formulae, processes,
and molecules), but might include
advice offered by non-European
regulatory authorities, plans for clinical
development, or protocols agreed
with non-European authorities and
marketers. The proprietary nature
of any assay developed for analysis
of a given product is a pretext not
to release pharmacodynamic and
pharmacokinetic data, as such
information might give competitors
a substantial advantage. Even
information that helps to make
the calculation for sample size
(eg, estimates of endpoint variability,
screening, and retention rates) might
be condential.
Misinterpretation of what is meant
by commercially confidential could
make it possible to conceal key
information, for instance, negative
results from a clinical trial or safety
alerts that could, if published,
possibly tarnish the image of a
product, and therefore the owners
economic interests.
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