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International Clinical Trials
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Partnering with Central Labs, ECG and Imaging Labs Outsourcing
Strategies Graham Hughes reports from Partnering with Central Labs, ECG
and Imaging Labs – an Informa Life Sciences Conference held in Brussels.
The ninth annual event in this series of thought-provoking conferences,
organised by Informa Life Sciences in Brussels on the 23rd-24th May
2012, got off to a difficult start. Presenters were forced to cancel at
the last moment or, in the case of one presenter, failed to catch the
right flight in order to make his presentation. Thus, the conference
agenda was rendered a little disjointed.
Day one’s keynote speaker, Chuck Cooper from the FDA, provided an
interesting update on the FDA’s policy regarding the use of electronic
data and standardised data submissions. He noted that the standardised
data format, CDISC, is now being used for some 50 per cent of
submissions, but also pointed out that it is not yet a requirement of
the FDA – and indeed may never be so. I recall an FDA presentation in
the early 1990s, which forecast that, by the year 2000, all submissions
would be in electronic format. However, this prediction has proved
false, and Cooper was unsure when, if ever, the FDA would make this a
requirement.
Simon Harper, a lawyer from Eli Lilly, discussed the recent UK
legislation in anti-bribery as it applied to clinical trials. This law
has widespread implications for pharmaceutical organisations, and will
require companies to assess risks, do due diligence on their clients,
communicate their policies to their staff and monitor and review what is
actually happening within their organisation in respect to bribery.
Interpreted strictly, the law may mean that it would be illegal in the
UK to buy an individual investigator as little as a coffee or a
sandwich, but it is possible to give a presentation to a group of
doctors taking part in the clinical trial.
A panel discussion of the challenges to the central laboratory industries noted the following factors:
- Biomarkers and large molecules
- Emerging countries
- The importance of cost reduction
- A lack of preferred provider relationships with individual laboratories
- Personalised medicine
- Translation of biomarkers into diagnostics
China is changing its legislation in relation to clinical trials and
particularly central laboratories. Details of this, and how to conduct
business in China, were discussed by Labcorp’s Marleen Hereygers and the
godfather of the outsourcing industry, Stephen Porter. Guy Mascaro from
the Metrics Champion Consortium gave a teleconference from the
organisation’s headquarters in the US. This worked surprisingly well,
and he shared a great deal of useful information on how the MCC is
developing.
On day two, there was an interesting panel discussion and group work
session which discussed the relationships between providers and their
clients. The discussion centred around trust, communications and
micromanagement, and urged participants to be honest, proactive,
transparent and to attribute no blame to their suppliers or their
clients. Olivier Simon of Biomedical Systems noted that pathology is now
becoming increasingly digitalised. Professor Elke Smits of the Antwerp
University Clinical Research Centre discussed how academics needed to
bridge the gap between themselves and the industry in order to make the
most of the technology available in universities.
In another session, James Denmark showed a video from Daniel Pink which
discussed motivation performance and success in clinical trials. Richard
Barrett, an independent consultant, noted that the Achilles heel of
clinical research is its handling of logistics. He felt that there may
be a need for more on-site labs in bigger trial sites, and noted that
there were always hidden internal costs in the use of outsourced
laboratories, especially if there were numerous local or national
laboratories involved in the trial. He further noted that the quality of
data is generally not an issue with laboratories, and neither is the
combination of data from various labs.
As usual, the conference was well organised by Informa in spite of their
difficulties with speakers, and it is with regret that we say goodbye
to Siobhan Corry, who is leaving Informa to return to her native
Australia.
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