Magee, Laura

Ross, Sue

Wood, Stephen

English

PubMed

Sue Ross

Laura Magee

Stephen Wood

Springer - Publisher Connector

ORAL PRESENTATION Open Access
Protecting intellectual property associated with
health technology trials – another barrier to
multi-centre trials?
Sue Ross1*, Laura Magee2, Stephen Wood1
From Clinical Trials Methodology Conference 2011
Bristol, UK. 4-5 October 2011
Objective
To examine the approaches to protection of intellectual
property in multi-centre trials currently being conducted
in Canada.
Methods
Two ongoing international multicentre perinatal trials,
both funded by the Canadian Institutes of Health
Research, were selected for study on the basis of their
contrasting approaches to protecting intellectual prop-
erty. These approaches were examined in detail to
understand their motivation, and to estimate the impact
of these approaches on centre recruitment.
Results
CHIPS (Control of Hypertension in Pregnancy Study,
ISRCTN71416914) – is recruiting 1028 pregnant
women in 14 countries. Women with hypertension are
randomised to tight or less tight control of hyperten-
sion. Primary outcome: composite of pregnancy loss/
neonatal intensive care.
Intellectual property is safeguarded by publishing the
protocol online [1]. Positive consequences: possible/
actual sites have easy access to full study design; poten-
tial for open discussion between collaborators; study
investigators will be held to high standards of reporting.
Negative consequences: details are available with poten-
tial for plagiarism.
FACT (Folic Acid Clinical Trial, ISRCTN23781770)
– is recruiting 3656 pregnant women in 4 countries.
Pregnant women are randomised to receive either 4 mg
folic acid or placebo daily. Primary outcome: develop-
ment of pre-eclampsia.
Intellectual property is safeguarded by requiring local
investigators/institutions to sign non-disclosure agree-
ments (NDAs) before the full protocol is provided. Posi-
tive consequences: details of the study not available
unless legal agreement is signed. Negative consequences:
may restrict academic openness; provide additional bar-
riers to site recruitment; investigators may present
selected results.
Conclusions
The two trials illustrate contrasting approaches to pro-
tecting intellectual property associated with study
design. This issue is becoming more important for aca-
demic institutions whose reputations and wealth are
influenced by ownership and management of the intel-
lectual property generated by faculty members. Some
institutions prefer to manage risk using legal measures.
In the case of trials, institutions protect their intellectual
property by introducing NDAs into the sub-site agree-
ment process.
NDAs between the lead institution and sub-sites may
represent a legally responsible approach. Unfortunately
there are potential disadvantages: adding an extra legal
step into sub-site recruitment will make this process
more difficult; this step may reduce academic openness
and collegiality; and restricting the availability of the
protocol could allow investigators to present selected
results.
The use of non-disclosure agreements is an increasing
trend in Canada. This trend will impact on the work of
clinical trialists, perhaps making site recruitment even
more difficult.
* Correspondence: sue.ross@albertahealthservices.ca
1Departments of Obstetrics and Gynaecology and Community Health
Sciences, University of Calgary, Calgary, T2N 2T9, Canada
Full list of author information is available at the end of the article
Ross et al. Trials 2011, 12(Suppl 1):A52
http://www.trialsjournal.com/content/12/S1/A52 TRIALS
© 2011 Ross et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Author details
1Departments of Obstetrics and Gynaecology and Community Health
Sciences, University of Calgary, Calgary, T2N 2T9, Canada. 2Department of
Medicine, University of British Columbia, Vancouver, V6H 3N1, Canada.
Published: 13 December 2011
Reference
1. CHIPS Protocol. [http://sunnybrook.ca/research/content/?
page=sri_proj_cmicr_trial_chips_prot], (accessed 14 June 2011).
doi:10.1186/1745-6215-12-S1-A52
Cite this article as: Ross et al.: Protecting intellectual property
associated with health technology trials – another barrier to multi-
centre trials? Trials 2011 12(Suppl 1):A52.
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Ross et al. Trials 2011, 12(Suppl 1):A52
http://www.trialsjournal.com/content/12/S1/A52
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Protecting intellectual property associated with health technology trials – another barrier to multi-centre trials?

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doi:10.1186/1745-6215-12-S1-A52 Cite this article as: Ross et al.: Protecting intellectual property associated with health technology trials – another barrier to multicentre trials? Trials

Submit your next manuscript to BioMed Central and take full advantage of: • Convenient online submission • Thorough peer review • No space constraints or color ﬁgure charges • Immediate publication on acceptance

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Protecting intellectual property associated with health technology trials – another barrier to multi-centre trials?

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