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Dear all:
I'd like to know if any of you had already gone through this
situation: I have here 2 female volunteers who became pregnant during
two studies (different ones): one between confinements and the other
after the second confinement but before the discharge examination.
I've looked up similar situations at boomer.org, with no success.
According to GCP:
"1.2 Adverse event (AE): An AE is any untoward medical occurrence in a
patient or
clinical investigation subject administered a pharmaceutical product
and that does not
necessarily have a causal relationship with this treatment. An AE can
therefore be any
unfavorable and unintended sign (including an abnormal laboratory
finding), symptom, or
disease temporally associated with the use of a medicinal
(investigational) product,
whether or not related to the medicinal (investigational) product (see
the ICH guidance for
Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting).
and...
4.3.2 During and following a subject's participation in a trial, the
investigator/institution should ensure that adequate medical care is
provided to a
subject for any adverse events, including clinically significant
laboratory values,
related to the trial. The investigator/institution should inform a
subject when
medical care is needed for intercurrent illness(es) of which the
investigator
becomes aware."
First, have anybody consider this pregnancy as an Adverse Event?
Second, apart from GCP does anybody know how to deal officially (in
any country) with the situation?
Thus, we basically have two options: we offer full assistance (costs
included) to those volunteers or with offer a "follow up", meaning
that we ask them to show up at the clinic, but we do not interfere
with any procedure that may arise from the pregnancy (this is, we will
not pay for any procedure and the volunteer is sent to the public
health system).
Finally, what's your personal opinion about this?
Thanks in advance for the help.
Best regards
--
Carlos E. Sverdloff
Project Manager
Synchrophar Clinical Trials
carsver.aaa.synchrophar.com
msn: csverdloff.at.hotmail.com
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The following message was posted to: PharmPK
The short answer is that the pregnancy is treated as an AE and in
general it is expected that you report the outcome of the pregnancy.
Jack McLane
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The following message was posted to: PharmPK
dear car,
oftern situation occurs with female volunteers,
i think you should dropout the subject on the basis and also do follow
up tests according to your drug.
details about medical impact on the basis of your investigational
product you have to taken care of.
secondly you should be carefull while enrollement/screening of the
subject as specially of female volunteers for pregancy test for your
future study i.e. beta hcg test etc,
according to the E2 guideline i dont seems that pregancy consider as
an AER.
ethics point of view you can take the adivise of your EC about the
follow up with cost. according to me for the best ethics you can go
ahead with cost and medico follow up (again according to your IP).
expert can comment !
regards,
paresh
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Dear Carlos
Usually pregnancy during a clinical trial is reported in a pregnancy
form to the sponsor (if the sponsor had provided one) with the
timelines for reporting followed as similar to SAE.
The reporting occurs in two steps to the sponsor:
1. At the time of identifying pregnancy
2. After the child birth.
If the drug is reported to have foetal toxicity effects, then the
child may be followed up to 18 years of age by the investigator
(though it is not written in an guidlines, but to ensure any toxic
effect indued by the drug). If not reported, it should be handled by
the investigator as per the guidance of ethics committee/sponsor/
regulatory authorities and if none of them had insisted, then the
investigator should do it on his discretion as well as based on the
interest of the subject.
If the trial drug is highly teratogenic (eg. isotretinoin), then a
Medical Termination of Pregnancy becomes very much necessary (as
decided by the experts and ethics committee/sponsor/regulatory
authorities). In such cases, usual follow up of the subject after MTP
is required.
Dear members, pls correct me if I am wrong.
Thanks
V.Rajesh
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