Project Description

Clinical trials are designed to answer questions such as:

  • Does a treatment work?
  • Does one treatment regimen work better than another?
  • Are there any side effects?
  • They are also aimed to improve health and quality of life for patients.

Until well-designed trials have been carried out, there is simply not enough evidence to know if a treatment is both safe and effective. 

Why do we (Skincare Studio) conduct Clinical Trial Research?

Under the stewardship of Dr. Tracey Brown-Maher, the Skincare Studio Clinical Trials research team is an active research facility assisting and collaborating on several development tiers of Dermatological Research.  We elected to participate in research activities simply because we wanted to be on the frontier of new medicines and new treatments for our Province.  Newfoundland and Labrador has the honor of being a much sought after research base in the global world population.

Ultimately we are involved in research because we have a profound calling in Skincare.  We make every attempt to be all-inclusive in what we consider Skincare:  Medical, Cosmetic, and Aesthetic.  Research affords us a front row seat to what is happening in all 3. We feel duty bound to represent our Province ethically and with human interests outweighing corporate profits.

Clinical Trials

PRINCIPAL INVESTIGATOR 1
NURSES 2
Research Coordinator 1
Research Analyst 1
Active Trials 6

  OPENING HOURS

Mon-Tue 8:30-5:00
Wednesday 8:30-5:00
Thursday 8:30 -5:00
Friday 8:30-5:00

   1.709.738.8420 Opt 1

But Why do Research in Newfoundland Labrador?

We elected to participate in Research activities simply because we wanted to be on the frontier of new medicines and new treatments for our Province.  Newfoundland and Labrador have the honor of being a much sought after Research base in the global world population.  This popularity is ours for several reasons:

  •  Almost 90% of the current inhabitants of Newfoundland and Labrador are descended from immigrants, mostly English and Irish, who settled here before the mid-19th century (Mannion, 1977, 5; Taubes, 2001; Industry Canada, 2002a, 103).
  • Many of the province’s present inhabitants belong to large, close knit families about whom good genealogical and medical records now exist, or can be readily assembled.
  •  A number of disorders occur or are suspected to occur among the current provincial population at unusually high frequencies, with cases often localized to particular regions. Examples include cardiovascular disease, diabetes, obesity and psoriasis (Atkinson, 2000; Taubes, 2001).
  • Residents of the province are generally willing to take part in scientific research. (Atkinson, 2000; Greenwood, 2000; Industry Canada, 2002a, 104)

Ultimately we are involved in research because we have a profound calling in Skincare.  We make every attempt to be all inclusive in what we consider Skin care:  Medical, Cosmetic, and Aesthetic.  Research affords us a front row seat to what is happening in all 3 aspects of skin care..

We feel duty bound to represent our Province ethically and with human interests outweighing corporate profits. 

Health Research Ethics Authority
Health Research Ethics Board

Regulatory agencies (like Health Canada and the U.S. Food & Drug Administration (FDA)) require that Clinical Trials be conducted in order to develop new treatments, prevention’s and devices for diseases or conditions. Clinical Trials are also referred to as Clinical Studies, Clinical Trials, Clinical Research Trials, or Research Trials.

There are strict regulations that the clinical trial doctors and their staff/research team members must follow when conducting Clinical Trials.

Health Research Ethics Authority

Here in the province of Newfoundland and Labrador we are mandated by the Health Research Ethics Authority Act. The ‘Act’ mandates that all health research conducted in Newfoundland and Labrador be reviewed by the provincial Health Research Ethics Board (HREB), overseen by the Health Research Ethics Authority (HREA).  

The Act defines ‘health research involving human subjects’ as “activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings and human biological material.” You can locate a complete copy of the Act here. You may also access the website of the HREA/HREB here.

Tri-Council Policy Statement (TCPS)
Good Clinical Practice (ICH-GCP)

Tri-Council Policy Statement (TCPS):

The TCPS expresses the continuing commitment to the people of Canada to promote the ethical conduct of research involving humans. It has been informed, in part, by leading international ethics norms, all of which may help, in some measure, to guide Canadian researchers, in Canada and abroad, in the conduct of research involving humans. More information about the TCPS can be located here.

Good Clinical Practice (ICH-GCP):

Good clinical practice (GCP) is an international quality standard for conducting clinical trials that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial; provides assurance of the safety and efficacy of the newly developed compounds; and include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. Information about the ICH-GCP can be found here.

Dr. Brown-Maher M.D. FRCPC
Dr. Brown-Maher M.D. FRCPCPrincipal Investigator
Medical Director

Conflict of interest declaration

Dr. Brown-Maher M.D. FRCSC, is one of our Research founding members and Principle Investigators.  She has conducted professional teachings for medical students.  Conducted ‘on call’ services for several hospitals and homes under the health authorities of Newfoundland and Labrador. Conducted professional teachings for pharmacy students.  Has received speaker’s honorarium from several drug companies. Has sat in on and was remunerated for several Ad Boards. Has previously received research grants from several pharmaceutical companies.

Dr. Brown-Maher holds no equity position or commercial interest with any company related to pharmaceuticals or medical equipment. Every pharmaceutical company and health authority have been treated exactly the same as the next. Dr. Brown-Maher is not affected or influenced by any industry corporate or personal commercial interests.

Dr. Brown-Maher supports any and all Dermatological ventures where she herself sees value in the offering.  She will not, nor has she ever been in a position where she has compromised any patient’s care for anyone!

Robyn O'Keefe
Robyn O'KeefeVice President
Research Coordinator
Enrollment
Sponsor Liaison
Kayla Bennett
Kayla BennettResearch Analyst
Ethics Officer
Enrollment
Records Management
Jodi Skinner
Jodi SkinnerResearch Nurse
Anne Marie Pitcher
Anne Marie PitcherResearch Nurse

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