Abstract
In this paper we were asked to review the draft policy issued recently by the EMA
and entitled Publication and access to clinical-trial data.
The view taken by the EMA in this draft policy, and the view taken in this paper, is
intended to optimise the benefits to public welfare resulting from the creation and
publication of clinical trials data, with a particular focus on strengthening the efficient
and safe use of existing health technologies and encouraging the development of
new ones.1
In the draft policy, the EMA takes the view that expanding publication and access to
detailed clinical trials data will help to resolve scientific logjams or gaps in knowledge
on a given medicine or condition, as well as enhancing cooperation in research areas
that have been lacking attention.
The move towards greater transparency and coordination in the design and
conduct of CTs is a worthy goal. The EMA’s initiative represents part of wider efforts
to optimise the increasingly complex and costly ecosystem in which R&D in the
biopharmaceutical field is carried out. Enhancing the collection and use of clinical
trials data will also benefit other siloes of the R&D process, ultimately to the benefit
of the public’s welfare.
The aspiration to achieve these goals is both merited and valuable. At the same time,
it is important to note that at least two other components of the biopharmaceutical
R&D environment – maintaining the privacy and confidentiality of patient data and
protecting the intellectual property rights and trade secrets generated in the clinical
trial phases – are also part of the puzzle. A balance between all of these pieces must
be achieved.
and entitled Publication and access to clinical-trial data.
The view taken by the EMA in this draft policy, and the view taken in this paper, is
intended to optimise the benefits to public welfare resulting from the creation and
publication of clinical trials data, with a particular focus on strengthening the efficient
and safe use of existing health technologies and encouraging the development of
new ones.1
In the draft policy, the EMA takes the view that expanding publication and access to
detailed clinical trials data will help to resolve scientific logjams or gaps in knowledge
on a given medicine or condition, as well as enhancing cooperation in research areas
that have been lacking attention.
The move towards greater transparency and coordination in the design and
conduct of CTs is a worthy goal. The EMA’s initiative represents part of wider efforts
to optimise the increasingly complex and costly ecosystem in which R&D in the
biopharmaceutical field is carried out. Enhancing the collection and use of clinical
trials data will also benefit other siloes of the R&D process, ultimately to the benefit
of the public’s welfare.
The aspiration to achieve these goals is both merited and valuable. At the same time,
it is important to note that at least two other components of the biopharmaceutical
R&D environment – maintaining the privacy and confidentiality of patient data and
protecting the intellectual property rights and trade secrets generated in the clinical
trial phases – are also part of the puzzle. A balance between all of these pieces must
be achieved.
| Original language | English |
|---|---|
| Publisher | Pugatch Consilium |
| Commissioning body | PhRMA and EFPIA |
| Number of pages | 39 |
| State | Published - Sep 2013 |