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CHU Sainte-Justine
Friday, October 5 2018
Press release

CHU Sainte-Justine reacts to report on "Enquête"

Montreal, October 5, 2018 – Last night, “Enquête” aired a report concerning a Phase 1 study on pediatric oncology conducted at CHU Sainte-Justine (CHUSJ) in 2015-2016. The report included a number of inaccuracies and innuendo. Out of respect for patients and their families, its professionals and employees, the CHUSJ had no choice but to set the record straight.

Overcoming pediatric cancers is an ambitious goal that drives our healthcare teams and researchers on a daily basis. We are dedicated to providing the best care for children with cancer in a way that is adapted to their needs. In light of this, we cannot ignore the allegations made in this “Enquête” report, which casts unfair doubts regarding our ability to ensure the safety of children,” said CHU Sainte-Justine Interim President and Director General, Ms. Isabelle Demers.

Health Canada Inspection

Following the suspension of the DEC-GEN study in November 2016, the CHUSJ acted quickly and reviewed its processes to follow Health Canada's recommendations, including:

  • The Research Centre commissioned an external firm to conduct a complete audit of its research processes;
  • The improvements recommended by this firm are in the process of being implemented;
  • External monitoring will be implemented as part of all subsequent Phase I studies;
  • A Research Quality Director has been recruited.

Health Canada confirmed that the patient deaths resulted from the progression of the disease, and that the observed adverse events were consistent with what was expected and described in the consent form.

Safe dosage

No children were endangered by participating in the DEC-GEN research project. The determination of the initial dosage was evaluated by Health Canada, as well as a US Scientific Committee and an internal scientific committee. All of these experts approved the administered dosage, which was strongly supported by available scientific data.

Consent

The consent process for a Phase 1 research project comes at a critical time in the patient's life and in an emotional and difficult context. In addition to the delicate exchanges which took place over a series of meetings with our professionals, a detailed consent form approved by the CHUSJ Research Ethics Committee was presented to families in support of their decision-making process.

Quality of the installations and overall quality standards

The environmental quality controls implemented at the CHUSJ go above and beyond both Quebec and Canadian standards. Throughout the DEC-GEN study, appropriate measures were put in place to ensure patient safety.

Hematology-Oncology Research

Clinical research is driving remarkable progress in the treatment of children’s cancers. After a quarter of a century of efforts made, the chances of recovery now exceed 80% for all pediatric cancers. The fight must continue, however, because even today, 20% of children with cancer do not respond to current therapy options and eventually succumb to their disease.

Dedicated teams

Our teams accompany patients and their loved ones in moments of great sadness, that is to say the moments when we see that medicine has reached its limits, and that the disease seems to be winning the fight. In these emotionally charged moments, each of us seeks to do our utmost in providing support. And to overcome the disease, one of the answers that the CHU Sainte-Justine can and must offer is to relentlessly seek new solutions,” concluded Ms. Demers.

A phone line for families

The CHUSJ is available to answer questions from families whose children are being treated in hematology-oncology. The number of the telephone line is 514 345-4961, extension 3856.

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About CHU Sainte-Justine

Sainte-Justine University Hospital Centre is the largest mother-child hospital in Canada and the 2nd largest pediatric center in North America. It is a member of the University of Montreal's large network of excellence in health (RUIS). It has 5,457 employees, including 1,532 nurses and nursing assistants and 1,000healthcare professionals, 520 physicians, dentists and pharmacists, 822 residents and more than 204 researchers, 411 volunteers, 4,416 students and students across all disciplines. The CHUSJ has 484 beds including 67 at the Marie Enfant Rehabilitation Centre (CRME), the only centre in Quebec dedicated exclusively to pediatric rehabilitation. WHO has recognized CHU Sainte-Justine "Hospital Promoter of Health."

For information

Jean-Philippe Lepage
jplepage@syrusreputation.com
Media line: 514 345-4931 x 7707
Cell: 514 260-1819

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Updated on 10/5/2018
Created on 10/5/2018
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