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There is still time to register for the next CCTG New Investigator Clinical Trials Course (NICTC) being held August 7th to the 9th in Kingston, Ontario.

The NICTC is an important component of the group mandate to provide and facilitate investigator education and training. The major goal of the course is to familiarize new investigators from across the country with the essentials of clinical trial conduct in the Canadian research environment.

The intended audience for this course is junior level faculty, fellows in oncology and translational scientists. This two day intensive provides clinical researchers in oncology with the basic tools for a future career in clinical research and will be accredited for Maintenance of Competence (MOCOMP) credits with the Royal College of Physicians and Surgeons of Canada. The 2019 New Investigator Clinical Trials Course marks the seventh anniversary of the course, originally founded in 2007.

For more information and the course application please visit the New Investigator Clinical Trials Course page on the CCTG website. If you have any questions, please e-mail: meetings@ctg.queensu.ca

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SEMINAR: Statistical Models vs Machine Learning in Health Research [May 2nd; live streaming available]

The Dalla Lana School of Public Health at the University of Toronto will be hosting a public lecture by Prof. Frank E. Harrell Jr. on Thursday May 2, 2019 from 11am to 12 noon, 155 College St. Room HS574. The title of the talk is “Musings on Statistical Models vs Machine Learning in Health Research”.

Registration for the event is required. The talk will also be available to access remotely by live streaming. If you register to participate for the event remotely an access link will be forwarded to you closer to the event.

The link to the registration site is
https://www.eventbrite.ca/e/public-lecture-musings-on-statistical-models-vs-machine-learning-in-health-research-tickets-60574892133

Description

Health researchers and practicing clinicians are with increasing frequency hearing about machine learning (ML) and artificial intelligence applications. They, along with many statisticians, are unsure of when to use traditional statistical models (SM) as opposed to ML to solve analytical problems related to diagnosis, prognosis, treatment selection, and health outcomes. And many advocates of ML do not know enough about SM to be able to appropriately compare performance of SM and ML. ML experts are particularly prone to not grasp the impact of the choice of measures of predictive performance. In this talk I attempt to define what makes ML distinct from SM, and to define the characteristics of applications for which ML is likely to offer advantages over SM, and vice-versa. The talk will also touch on the vast difference between prediction and classification and how this leads to many misunderstandings in the ML world. Other topics to be covered include the minimum sample size needed for ML, and problems ML algorithms have with absolute predictive accuracy (calibration). Presented by Professor Frank E. Harrell, Department of Biostatistics, Vanderbilt University.

About the Instructor:
  • Professor and founding Chair of the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville TN USA
  • PhD in Biostatistics from U. North Carolina
  • Extensive work in biomedical and pharmaceutical research
  • ASA Fellow and winner of the ASA WJ Dixon Award for Excellence in Statistical Consulting in 2014
  • Publications
  • Active on stats.stackexchange.com – see my posts here
  • Written several R packages including Hmisc and rms
  • Used R intensively since 1999 and am a member of the R Foundation
  • Author of Regression Modeling Strategies, 2nd Edition
  • Statistical knowledge outside the areas of regression modeling strategies and Bayes is in BBR
  • Expert Statistical Advisor to the Office of Biostatistics, Center for Drug Evaluation and Research, FDA

CLICK NOW for agenda and registration for the ENACT symposium at Sick Kids | Learn about translating innovative research tests into clinical care (June 12th)

Register now at www.eventbrite.com/e/symposium-next-generation-research-testing-tickets-60057100404

This multidisciplinary meeting will highlight emerging challenges and opportunities in test development through transnational research, and will bring together experts to address current limitations of provincial regulations for novel testing.

Date:
June 12th, 2019
Time:10:00 am – 4:00 pm
Place:SickKids, PGCRL Auditorium, 686 Bay St, Toronto
Agenda:

10:00 – 10:20am Welcome and Introduction
Dr. Ronald Cohn, MD, FACMG, Incoming CEO, SickKids; Dr. Michael Salter, MD, PhD, FRSC, Chief of Research, SickKids; Dr. Meredith Irwin, MD, Co-Chair ENACT Committee, Associate Chair (Research) Paediatrics, SickKids; Dr. Rulan Parekh, MD, MS, FRCP(C), FASN, Co-Chair ENACT Committee, Associate Chief of Clinical Research, SickKids

10:20 – 11:20am Keynote Address
Dr. Jeffrey Botkin, MD, MPH, Chair of National Academies of Sciences, Engineering & Medicine Committee that authored “Returning Individual Research Results to Participants” will discuss the reaction to the report, as well as other issues and challenges that have arisen in this area.

11:20 – 11:30am Coffee Break

11:30 – 12:10pm Test Development and Implementation
Dr. Wendy Ungar PhD, Chair of Ontario Genetic Advisory Committee, Health Quality Ontario; Dr. Susan Richardson, MD, FRCP(C), Senior Associate Scientist Emeritus, Research Institute, SickKids, Adjunct Scientist, Public Health Laboratories, Public Health Ontario

12:10 – 12:30pm The Next Frontier: Whole Genome Testing
Dr. Christian Marshall, PhD, Director, Molecular Genetics, SickKids

12:30 – 1:15pm Lunch

1:15 – 1:45pm Cancer Gene Panel Development
Dr. Adam Shlien, PhD, Associate Director of Translational Genetics, SickKids

1:45 – 3:30pm Testing Innovation Panel Discussions
Moderators: Dr. Gabrielle Boulianne, PhD, Associate Chief, Science Strategy & Innovation, SickKids; Dr. George Yousef, MD, PhD, Chief, Paediatric Laboratory Medicine, SickKids
Panellists: TBD

3:30pm Concluding Remarks and Next Steps
Dr. Meredith Irwin, MD, Associate Chair (Research) Paediatrics, SickKids; Dr. Rulan Parekh, MD, MS, FRCP(C), FASN, Associate Chief of Clinical Research, SickKids

SickKids leadership assembled the ENACT (ENAbling Clinical Translation) committee to examine and address issues related to the development and use of novel tests to guide clinical diagnosis, prevention or treatment. Comprised of clinicians, clinician scientists, basic researchers, legal experts and bioethicists, the ENACT committee is working to create guidelines and policies for tests not currently covered by regulations; make recommendations around the development, use and validation of novel tests and return of results; and develop processes to provide access to innovative research tests and ultimately translate clinically validated tests into care.

Pat McCarthy’s report from the 8th International Meeting on Indigenous Child Health–Jon’s Tricky Journey

Jon’s Tricky Journey was funded by a C17 Council Education Research Grant

I had the good fortune to be able to attend and present a poster abstract at the 8th International Meeting on Indigenous Child Health, held in Calgary, Alberta, March 22-24, 2019. This was an amazing experience with pediatrician’s, nurses and child and youth advocates from many countries attending. The conference was organized by both the Canadian and American Pediatric Societies in collaboration with numerous First Nations, Metis and Inuit associations. This conference is held every two years, and I would encourage anyone to attend.

The plenary, oral, and poster presentations were all very thought provoking and challenged participants to think more about the health disparities and systemic barriers that exist for aboriginal peoples around the world. At the same time conference participants were inspired to think about how they could, as individuals, pick up the challenge and make a commitment to become allies in relationships with aboriginal peoples, to change and improve the health outcomes for indigenous children.

My poster presentation about my book Jon’s Tricky Journey was very well received, and I was especially touched when a young pediatric oncologist from Seattle came to see me and kept thanking me for producing this book. I gave her a big hug and a copy of my book, and she told me she could not wait to give it to a young Inuit patient from Alaska she was working with. Alaska has a large Inuit population called the Yupik.

Jon’s tricky journey is a bilingual publication, written in both English and Inuktitut. Accompanied by a resource guide for parents and caregivers, including hospital and support information, Jon’s Tricky Journey opens a conversation between Inuit children facing a cancer diagnosis and their families to help make a difficult and confusing time more manageable.

My book is available to order through Fitzhenry & Whiteside customer service at 1-800-387-9776, and at bookinfoatfitzhenry.ca

It is also available for order on Amazon in both Canada and the USA, and at Chapters/Indigo stores.
https://www.amazon.ca/Jons-Tricky-Journey-English-Inuktitut/dp/1772271454/ref=sr_1_fkmrnull_1?keywords=jon%27s+tricky+journey&qid=1554213991&s=gateway&sr=8-1-fkmrnull

Attend the ENACT symposium at Sick Kids on June 12th to learn about translating innovative research tests into clinical care

Sign up to be notified when registration opens.

This multidisciplinary meeting will highlight emerging challenges and opportunities in test development through transnational research, and will bring together experts to address current limitations of provincial regulations for novel testing.

Keynote:Dr. Jeffrey Botkin
Chair of National Academies of Sciences,
Engineering & Medicine Committee that
Authored Returning Individual Research Results to Patients
Date:
June 12th, 2019
Time:10:00 am – 4:00 pm
Place:SickKids, PGCRL Auditorium
686 Bay St, Toronto

SickKids leadership assembled the ENACT (ENAbling Clinical Translation) committee to examine and address issues related to the development and use of novel tests to guide clinical diagnosis, prevention or treatment. Comprised of clinicians, clinician scientists, basic researchers, legal experts and bioethicists, the ENACT committee is working to create guidelines and policies for tests not currently covered by regulations; make recommendations around the development, use and validation of novel tests and return of results; and develop processes to provide access to innovative research tests and ultimately translate clinically validated tests into care.

WEBINAR: Synoptic Pathology Reporting for Pediatric Patients with Hepatoblastoma

Please confirm your participation in this free webinar by April 1st, and register online, by visiting http://www.pogo.ca/education/synoptic-reporting/

On April 3, 2019, POGO is pleased to present an important professional development educational event in partnership with the Canadian Association of Pathologists (CAP-ACP) and the Canadian Partnership Against Cancer (CPAC).

The webinar “Synoptic Pathology Reporting for Pediatric Patients with Hepatoblastoma” will provide expert advice for advancing pediatric oncology through optimal pathology investigation, moving toward standardized reporting, and incremental clarity of clinical implications.

Date: Wednesday, April 3, 2019
Time: 1:00 – 2:30 p.m. (60 minutes presentation; 30 minutes Q & A)

Speaker: Dr. Dina El Demellawy, MD, PhD, FRCPC
Pediatric and Perinatal Pathologist, Children’s Hospital of Eastern Ontario (CHEO) Associate Professor, Department of Pathology and Laboratory Medicine Faculty of Medicine, University of Ottawa

Audience: Pathologists, Pathology Fellows and Residents;
Pediatric Oncologists, Surgeons, Radiation Oncologists; Clinical Research Associates (CRAs).

Learning Objectives:

  1. To review the CAP protocols related to Hepatoblastoma and its use by pathologists specializing in pediatric oncology.
  2. To understand changes in the latest revision of the CAP cancer protocols and electronic cancer checklists.

Participation details: Please confirm your participation in this free webinar by April 1st, by visiting http://www.pogo.ca/education/synoptic-reporting/ to register online.

For questions about registration, please contact Clara Jordan at cjordan@pogo.cacjordan@pogo.ca or 416-592-1232 ext. 237. Webinar login details will be provided in advance of the event.

Recording of LLSC WEBCAST now available – Children & Teens with Cancer: Challenges at School after Treatment


Speaker: Ann Klinck, M.A.Sc., C. Psych. Assoc., School Liaison, Pediatric Cancer School Support Program, Children’s Hospital, London Health Sciences Centre, Ontario

This training is useful for those who support children and teens during and after the cancer experience including parents, relatives, teachers, school support staff and nurses. The recording of this webcast can found on our Website at: www.llscanada.org/events/children-teens-with-cancer-challenges-at-school-after-treatment?src1=22346&src2=

Questions? Contact Fred Ho at The Leukemia & Lymphoma Society of Canada | fred.ho@lls.org | http://www.llscanada.org

Register for the N2 AGM by Jan 22.

REMINDER: Please register online no later than Tuesday January 22, 2019.

One of the benefits of membership in N2, either through C17 or your local institutional or provincial membership, is that you can attend the annual meeting of members. This meeting has an educational and information focus, providing updates and presentations on current issues impacting clinical trials in Canada, as well as updates from the various N2 committees.

You are cordially invited to attend the 12th Annual N2 Meeting to be held at Vantage Venues (previously the St. Andrew’s Club and Conference Centre) http://www.vantagevenues.com in downtown Toronto on February 5-6, 2019. (Please note this is a Tuesday and Wednesday).

The full agenda can be found HERE.

As a member of N2, you are encouraged to attend this important meeting and network with your colleagues. The N2 Annual Meeting is also open to additional members of your clinical research organization. If they wish to accompany you to the meeting, they are welcome to attend.

To view information about the event and register, please follow this link: https://n2canada.ca/n2-annual-meeting/

Attendees requiring travel assistance must contact Karen Arts karen.arts@n2canada.ca for pre-approval. Assistance of a maximum of $750 is available for one member per organization, outside the greater Toronto area for the cost of travel to and from Toronto. The funds may be used for flight and/or rail costs only.

For anyone in your clinical research organization wishing to attend, please ensure they register by completing the on-line registration here: https://secure.e-RegisterNow.com/cgi-bin/mkpayment.cgi?state=2772

Due to increasing economic pressures, the N2 Board of Directors has approved a registration fee of $50.00 (+HST) per person. This fee of $50 plus HST is payable by credit card only. This fee is to offset some charges incurred on catering, venue rental and AV equipment required to hold the two-day annual meeting. To ensure accurate catering estimates it is imperative we know the total number of attendees ahead of time by having everyone register. Please register online no later than Tuesday January 22, 2019.

We hope to see you at the meeting.

Shelley

New Investigator Cancer Trials Practicum 2019 – 2020 [applications due 11-Feb-2019]

The Canadian Cancer Trials Group (CCTG) is very excited to announce that the the 2019-2020 New Investigator Cancer Trials Practicum applications are open. This is a unique opportunity for new investigators to access hands on training and practical work in the field of cancer clinical trials. The purpose of the CCTG New-Investigator Cancer Trials Practicum is to deliver a training program that includes practical trial experience at cancer sites across the country over a one-year period. This opportunity is the first of its kind in Canada enabling the best and brightest new oncology researchers to acquire training and experience.
New Investigator Cancer Trials Practicum 2019 - 2020

Application deadline is February 11, 2019

To find out more: New Investigator Cancer Trials Practicum

N2 fall newsletter includes updates to French CITI courses, info on the N2 SOP tool, and how to access ACRP Ethics and Human Subjects Protection course free of charge

Excerpts from the newsletter are below–read the whole newsletter at https://mailchi.mp/6669b546f52d/read-the-fall-n2-newsletter

Updates to CITI Courses!

The French GCP Refresher course is now available to N2 members. It has been translated into French from the current CITI Canada E6 (R2) compliant GCP Refresher course. Shelley is working with institutional administrators to add the course to N2 member sites. Please allow 5-10 business days for the requests to be processed.

ACRP Ethics and Human Subjects Protection courses available at no charge!

After registering select Pricing Without Contacts Hours at the following link:

www.acrpnet.org/courses/ethics-human-subject-protection/

  • Note: there is currently not the ability to generate a completion certificate, instead participants are instructed to take a screenshot of the transcripts area that indicates they have taken the course
  • Sometime in November, ACRP will launch the Refresher course (about 45 minutes in length) to this topic.
  • If there are any questions, David Burnham can be reached at david.burnham@acrpnet.org

Standard Operating Procedure (SOP)

  • The SOP committee is reviewing V7 N2 SOPs to prepare for V8, scheduled to be distributed in April 2019.
  • This committee is encouraging new members to join. Please contact N2 if you are interested.
  • N2 CAREB/ACCER REB SOP committee will reconvene this Fall, working on V.3 to be released in 2019.

N2’s Featured Tool: Standard Operating Procedures (SOPs)

  • Maintenance of one set of investigative site SOPs (version 7) for all Canadian trial sites (community & academic), accepted by Health Canada
  • All “regular” clinical trials, Natural Health products, Medical Devices, Equipment Calibration, Investigator Initiated Research
  • BiospecimenManagement related SOPs via OICR
  • REB SOPs created with CAREB
How to Use This Tool?  Please log onto your N2 Box account from the login page from n2canada.ca. If you have any trouble accessing your account please contact Shelley King at shelley.king@n2canada.ca. Please contact N2 if you need any further help with using SOPs.

Quality Committee Update

There are three tools the committee are working to complete:

  • Quality Management System policy and procedure
  • Study Risk Assessment Tool is a two-level resource
  • Risk-Based Monitoring Plan

The committee has collaborated with Health Canada to collate and analyze feedback received regarding the final draft of the Part C, Division 5 regulations guidance document GUI-0100.

Education & Training Committee Update

There are two courses that are in the process of being reviewed and finalized:

  • RCR Mega Course which is a combination of Life Sciences, Physical Sciences and Social Humanities- Expected release date: end of 2018)
  • Clinical Research Coordinator Course (CRC) – Expected release: early 2019

French GCP Refresher released early this month. The French GCP Basic course is currently being translated and is expected to be released next year.