Cancer Research in Switzerland - Krebsliga Schweiz

tory requirements would also be desirable for therapies
that in addition to chemotherapy also include
surgery and/or radiation therapy, or for projects such
as quality of life research and studies on health economics
(for example, requirements in the areas of
bookkeeping, safety reporting, reporting of insignificant
protocol changes) [3].
To make the best possible use of the existing leeway
in the regulations, all parties involved (study leader,
organization conducting the trial, ethics committee,
Swissmedic) need more training, experience, mutual
trust, and a good eye for realistic risk assessment.
Through this, for instance, unnecessary duplication
such as the review of one and the same study by
multiple ethics committees could be avoided. In addition,
clear designation of responsibilities is important:
For instance, Swissmedic could recognize the
decisions by ethics committees or by the Federal
Data Protection and Information Commissioner
(FDPIC), without having to evaluate these aspects of
the study proposals all over again. These are certainly
ways to increase the efficiency of research and
improve utilization of the available resources without
any loss of quality [3]. Some studies even showed
that duplicative reviews and in part contradictory
decisions worsen the quality of research rather than
improve it [4].
Issues concerning the new Swiss law on research
involving humans
Elaboration of the law on research involving humans
(Humanforschungsgesetz, HFG) is very important
for the future of clinical research. Fortunately, some
of the suggestions mentioned above were already
discussed in the first parliamentary deliberations on
the HFG. Many research institutions agree that the
law should not strictly adhere to the GCP guideline
word-for-word in all areas of clinical research but
should rather lay down the fundamental principles of
the GCP. It would also seem appropriate to exempt
clinical trials using already approved medicines from
the requirement to obtain approval by Swissmedic as
well as to provide a simplified approval process for
international studies that have already been approved
by responsible foreign authorities. In countries having
comparable regulatory and legal standards (such as
EU countries, the United States, and Canada), the research
topic and the ethical context are reviewed in
an analogous manner as they are in Switzerland before
a clinical trial is approved. For that reason, yet
another scientific review by the Swiss authorities is
unnecessary. What should be reviewed in Switzerland
would then be only the national and local conditions,
such as the qualifications of the study leader and the
competency of the centre.
Unquestionably, all clinical trials should be recorded
in study registries that are accessible to the public.
This improves the coordination of research efforts
and also makes it difficult for those conducting the
study to conceal unwanted findings. This should include
recording the studies in international study
registry databases that are already being run successfully,
as the SAKK and its cooperation partners in
national and international patient-centred cancer research
have done for years.
Cost coverage for standard medical procedures
in studies
One problem in clinical research that should be better
regulated by law is cost coverage by the health insurer
for the study patients’ routine diagnostics and
routine treatments. The medical treatment and care
costs in patient-centred clinical studies should be –
as in other industrialized countries – covered by
the health insurance companies [5, 6]. Without this
prerequisite, clinical research in Switzerland would
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