Pragmatische Lösung eines komplexen Problems Schweizer ...

SCHWERPUNKTTHEMA
Challenges in Launching
Multinational Clinical Trials
in Switzerland:
the EORTC perspective
Anastassia Negrouk 1 and Roger Stupp 2
1
Regulatory Affairs, Headquarters, European
Organisation for Research and Treatment of Cancer,
Brussels, Belgium, 2 VicePresident, EORTC
The EORTC (European Organization for Research and
Treatment of Cancer) is a multinational cooperative group
aiming at improving cancer care. Legally, the EORTC is
a non-profit foundation under Belgium law. The EORTC
remains the only academic organism conducting transnational
clinical trials in most European countries. Switzerland
and Swiss investigators have been active contributors
since the birth of the organization, with many
Swiss researchers holding leadership functions within the
EORTC. In terms of patient accrual, Switzerland is the
7th leading contributor (1108 patients recruited by Swiss
investigators to EORTC trials for the period of 2000-
2009). Approximately 50% of currently active EORTC
trials are open to patient accrual in Switzerland.
Clinical research is an important and indispensable
means to progress and better medical for patients, and
EORTC Headquarters,
Brussels, Belgium
in particular for cancer patients.
Large, international
and collaborative trials are
often the only way to demonstrate or reject the efficacy
of a novel or modified treatment. Research in human
beings is a very sensitive matter that needs to be performed
under a strict ethical and legal framework. Over
the years European legislation has created a framework
to guarantee patient protection while aiming at harmonizing
the process. The current European Clinical
Trials Directive was finalized in 2001 and is applicable
in the EU member states since May 2004. Similarly,
Switzerland produced in 2001 the ordinance on clinical
trials with therapeutic products (referred to as OClin
or VKlin) applicable since 2002, and updated in 2004,
2007 and most recently in April 2010).
Discussion points and proposals for future collaboration:
• Trial conduct and requirements should be risk adapted, e.g. a different level of surveillance and monitoring may
be required for a first-in-man phase I study or early phase II study with a entirely novel agent, compared to a
treatment optimisation protocol with approved and marketed agents, or research aiming at identifying novel
molecular or radiological biomarkers.
• Guidelines to clarify the scope of the legislation with clear examples should be established.
• A centralized or leading ethical committee review system should limit the number of contradictory requirements.
• A parallel submission process to Ethic Committees and Competent Authorities should be allowed and facilitated.
Clear definition of mutual responsibilities of each regulatory body is required, overlaps should be avoided. A
direct communication between Competent Authorities and Ethical Committees should allow for streamlining
processes and rapid unbureaucratic elimination of discrepancies.
• Verification of contractual agreements should be limited, and focus on patient protection and definition of responsibilities.
Request of potentially confidential and sensitive information needs to be restricted and clearly defined.
A list of mandatory requirements would help sponsors to negotiate adequate agreements with third parties and
grant providers. Harmonization of Swiss requirements and EU would greatly simplify the processes.
• Transfer of pseudo-anonymized (key-coded) data should be allowed provided that the third country partner would
never be in procession of the key.
• The value of future research should be recognised, and a clear set of easy rules should be in place to make it possible
with respect to ethics and patient rights and willingness to participate to future research.
218 Schweizer Krebsbulletin • Nr. 3/2010