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Individuals who take part in a Roche clinical trial on the safety or efficacy
of a new
medicine are generally asked to consider giving an extra blood sample for the explicit
purpose of supporting research aimed at understanding the role of genetic differences
among patients and their response to medicines.
Current disease definitions and diagnoses rely, mostly, on clinical parameters, but rarely
take the actual underlying causative or contributory factors on the level of molecular
cell (dys-)function, into account. Commonly, a disease entity defined by single clinical
diagnosis is actually comprised of several distinct entities on the level of molecular
disease causation; conversely, sub-segments of several clinically distinct diagnoses may
share a common pathologic principle on the molecular level. Because it is at the molecular
level where drugs exert their effects, it stands to reason hat treatment according to a
molecular understanding of disease will provide the greatest probability for success.
Greater likelihood of treatment success is thus related to more accurate differential
diagnosis and the resultant opportunity to choose the most appropriate drug.
In addition, even individuals with the same molecular disease mechanism may differ from
each other in their response to the medicine of choice based on small differences in the
makeup of their proteins that affect the absorption, distribution, local efficacy at the
drug target, metabolism, and excretion of the medicine. A better understanding of these
differences based on studying the correlations among treatment outcome and a number of
medical parameters, including genetic, genomic, and proteomic studies, will eventually
allow us to tailor treatments towards higher efficacy and fewer side effects.
Collecting samples for research
To arrive at this understanding, study participants in many of Roche's clinical trials
will be asked to contribute to the required research. If they agree, a blood sample will
be taken and stored frozen in a central facility, the Roche Sample Repository (RSR). To
carry out medical research, scientists will extract DNA, proteins, or other chemical
components from the blood sample. While we refer here primarily to the work foreseen to be
carried out on DNA level, analogous procedures can be carried out using proteomics or
other methods to characterise the composition of the sample.
The samples will be anonymised by a sophisticated encryption process to guarantee
confidentiality and may be stored for a number of years, as scientific advances may make
it feasible to addressed additional important questions. If a person decides to donate a
blood sample, he or she is free to change his/her mind and request withdrawal of the
sample until the point at which the anonymisation has taken place. DNA extracted from
these samples will be examined for correlations between certain genetic variants and
patients' response to the drug tested. Only gene variants considered relevant to the
disease area under investigation will be examined. Important results from the collective
analysis of a large, representative number of samples will be published in medical
journals so that everyone can benefit from the new knowledge.
Safeguarding privacy
To safeguard patient privacy, Roche ensures that the blood samples are separated from all
information that may disclose the identity of a participant. Although patients' names are
never transmitted to the company, the RSR samples undergo an additional encryption step
that will provide additional strong safeguards against any possible breach of
confidentiality. While this policy precludes Roche from disclosing any genetic information
to individual study participants, the publication of aggregate results will provide
physicians with the information they need to advise their patients about whether or not
they should undergo particular tests. |
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