On May 7th, Mr. Yadvinder Bhuller, Manager - Clinical Group II/, Office of Clinical Trials, sent us the following message which in essence does not answer our questions. It only gives us the general guidelines of procedures before clinical trials are given the green light. We still don’t know if independent research was conducted and if clinical trials were indeed approved. To trust our doctor, is about all we can make out of this e-mail. It does not tell us on who’s information our doctor relies, or if there was conflict of interest involved. We are presently still trying to determine how and to who we can address our questions so that we can get a clear answer.
As per my v-message, your original email was re-directed to my attention
and I do apologize for the delay in providing you with a response. With
respect to your inquiry, please note that Health Canada oversees the
regulation of health products at the federal level, which includes
regulating clinical trials, authorizing the sale of a product for the
Canadian market and emergency treatment via the special access programme
(SAP). In addition, HC also ensures that the product monograph and label
have all the relevant information such that the consumer can make an
informed choice. Using nicotine replacement therapies (NRT) as an example,
the use of all marketed non-prescription NRT that currently hold DINs
(e.g. gum, inhaler and patch) are contraindicated for use in pregnant or
nursing women. Additionally, product monographs for these products advise
women of childbearing age to take adequate precautions to avoid becoming
pregnant while using these products.
Please note that while it is generally recognized that smoking is worse
than nicotine alone, no safe dose of nicotine in pregnant women has been
established. Therefore, pregnant women should be encouraged to use
behavioural approaches before considering taking NRT's. However, if
pregnant women who smoke do use NRTs as an aid to quitting smoking, they
should be apprised of the potential hazard to the fetus, within or outside
a clinical trial setting. For the later, the decision to use NRTs during
pregnancy should be made in consultation with a health care provider and
should consider the relative risks and benefits of using NRTs.
Furthermore, a physician's decision to use a particular product, such as
NRT, in the treatment of an individual who has a specific condition is part
of the "practice of medicine," which is an area regulated by the local,
provincial college of physicians and surgeons.
With respect to clinical trials, under the Canadian clinical trial
regulations, prior to initiating a clinical trial a sponsor must submit a
clinical trial application to Health Canada for review and authorization.
As you probably are aware, clinical trials are conducted to investigate
whether the use of a drug is safe and effective, what dosages are most
effective and what side effects may be associated with the use of the drug
in humans. However, I am not certain if you are aware of the clinical
trial application process and thus, I have briefly described it below for
your convenience:
Under the current regulations governing clinical trials in Canada, a
scientific review of all clinical trial applications is required, by
Health Canada, before a drug can be sold or imported by a sponsor for
use in a trial. Health Canada evaluates the appropriateness of all the
available evidence for the safety, efficacy and quality of the product
and the design of the trial protocol that is provided in a clinical
trial application. The main objective of this review is to ensure that
the sponsor has the appropriate parameters in the application such that
known risks to participants are: identified and minimized; detailed and
communicated via the Informed Consent Form; detailed in the
Investigator’s Brochure; and are acceptable within the context of the
medical condition to be treated, the alternative treatments available,
and study population identified in the protocol;
Health Canada or more specifically the Minister will only authorize the
sponsor to sell or import the product for the purposes of a clinical
trial if the Minister has reasonable grounds to believe, based on the
assessment of the application and all related information, that the use
of the product in the trial will not endanger the health of a clinical
trial subject or other person, that the clinical trial is not contrary
to the best interests of the clinical trial subjects, and that the
objectives of the clinical trial will be achieved;
Health Canada is not responsible for evaluating the ethics of clinical
trials or conducting the trial. However, part of the regulations also
includes the requirement that a sponsor obtains ethics approval for all
trials from a properly constituted Research Ethics Board (REB) prior to
initiating the study; and
It is also the sponsor’s responsibility to conduct the trial in
accordance to the regulations and the principles set forth in the
internationally recognized ICH Good Clinical Practices Guidelines. This
would include, but is not limited to having a qualified investigator
(i.e. a physician) who is responsible for all trial-related medical
decisions including obtaining the informed consent of trial
participants.
Finally, I hope the information provided above identifies the 'steps' that
Health Canada takes in order to review a clinical trial application and
also in relation to your concerns related to NRT. However, should you have
any additional questions, please do not hesitate to contact me directly.
Kind regards,
Yadvinder Bhuller
________________________
Manager - Clinical Group II/
Gestionnaire,
Programme des essais cliniques Groupe II,
Office of Clinical Trials / Bureau des essais cliniques,
5th Floor, Holland Cross,Tower B /
5ième étage,Holland Cross, Tour B,
AL 3105A OTTAWA K1A 0K9
Tel: 613-941-0570
Fax: 613-952-9656
C . A . G . E .
