Archive | clinical trial resources RSS for this section

ACRP Announces Unrestricted Public Access to ‘Introduction to Clinical Trials’ Training Program. Suitable for staff (1.0 CBRN, ACCME), students and families.

Free Program to Help Develop Competence in Clinical Research Workforce and Raise Awareness of Clinical Trials

Washington, DC – The Association of Clinical Research Professionals (ACRP) announced immediate availability of a free educational program, “Introduction to Clinical Trials.”

Introduced at DIA 2016 in Philadelphia, PA, last month, Introduction to Clinical Trials provides fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals.

The course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review, and approval of medical products. The one-hour online program also explores how historical studies have laid the path for creation, revision, and enforcement of the ethical principles and guidelines governing today’s clinical trials.

“ACRP is proud to offer this fundamental education in support of our mission to promote excellence in clinical research,” says Jim Kremidas, ACRP Executive Director. “As the leader in clinical research workforce development, providing those new to the profession with a core understanding of clinical research is a critical initiative for ACRP. We are thrilled to be able to freely provide this program to individuals, clinical trial sites, contract research organizations, and trial sponsors and suppliers. Thank you to Labconnect LLC for providing ACRP the educational grant to develop this program.”

Introduction to Clinical Trials is an ideal program for novice clinical researchers, including investigators, coordinators, and trial monitors, to develop the foundational knowledge upon which they can develop their competence as clinical research professionals. The program is also perfect for those interested in the profession or indirectly involved in clinical trials.

Introduction to Clinical Research is immediately available for free individual use through ACRP’s Learning Management System (LMS) here. The SCORM-compliant program can also be hosted on organizational Learning Management Systems. Contact Jenna Rouse, ACRP Director of Business Development, at jrouse@acrpnet.org or +1.703.254.8109 for information.

In addition to supporting clinical research professionals and organizations, this program is an ideal tool for organizations seeking to help educate the public about clinical research and to raise awareness of clinical trials and the clinical research profession.

“We welcome everyone looking to spread the word about clinical research to leverage this resource, including the academic institutions and other associations around the world educating those who will ultimately become the workforce of tomorrow,” says Kremidas.

Introduction to Clinical Trials is accredited by the Accreditation Council for Continuing Medical Education to provide 1 Continuing Medical Education credit for physicians, and by the California Board of Registered Nursing to provide 1 contact hour of continuing nursing education credit.

Continuing Nursing Education

The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. This live activity provides 1.0 contact hours of continuing Nursing education credit (Program Number 11147-2016-ICR-100).

Accreditation Council for Continuing Medical Education

The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide Continuing Medical Education for physicians.

The Association of Clinical Research Professionals designates this live activity for a maximum of 1.0 AMA PRA Category 1 credits™. Each physician should only claim credit commensurate with the extent of their participation in the activity.
CME Program Number: 0007229-2016-ICR-100

ACCME Physician Attributes

  • Work in interdisciplinary teams – cooperate, collaborate, communicate, and integrate care in teams to ensure that care is continuous and reliable
  • Apply quality improvement – identify errors and hazards in care; understand and implement basic safety design principles, such as standardization and simplification; continually understand and measure quality of care in terms of structure, process, and outcomes in relation to patient and community needs; and design and test interventions to change processes and systems of care, with the objective of improving quality
  • Employ evidence-based practice – integrate best research with clinical expertise and patient values for optimum care, and participate in learning and research activities to the extent feasible

Subject Matter Expert Developers

  • Eric Hayashi, President & CEO, Labconnect, LLC
  • James Chrisman, Labconnect, LLC

About ACRP

ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based nonprofit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research. www.acrpnet.org

CONTACT:
Jovan Petty
+ 1.703.258.3520
media@acrpnet.org

New Agents and Innovative Therapy Program (NAIT) at Sick Kids :July newsletter and current list of open studies

The July 2016 NAIT newsletter can be found HERE.

WHAT’S NEW: IND 218 VITORI is now open at Sick Kids, as well as at BC Children’s, CHEO, and CHU Ste-Justine.

SickKids is one of only two centres in Canada offering MIBG therapy.
For more information, please visit: http://www.sickkids.ca/gfcc/mibg/index.htm

BOOKMARK NAIT:  The current list of all open trials can be found on the NAIT Website at https://www.sickkids.ca/HaematologyOncology/nait/index.html

HELPING FAMILIES NAVIGATE:  To assist patients and families with their transition, our Patient Navigator Program will collaborate with your team and the family to provide assistance with issues related to travel, accommodation, and navigating their way around the hospital and in the city. Furthermore, for patients living outside of Ontario, our Patient Navigator will assist physicians in completing an Out-of-Province Prior Approval Application to the Provincial Ministry of Health.

The vision of the New Agents and Innovative Therapy Program (NAIT) supports The Garron Cancer Centre and SickKids’ commitment to innovation and providing Canadian children and their families living with cancer with greater access to the best and newest treatment that will assist to improve clinical care.

See the active and upcoming studies available though the NAIT program at Sick Kids–April 2016 Newsletter


Find attached NAIT Newsletter April 2016, listing the clinical trials available through the Clinical Trials and New Agent and Innovative Therapy (NAIT) Program at SickKids.

A list of all active and upcoming studies available through NAIT can be found HERE.

The vision of the NAIT supports The Garron Cancer Centre and SickKids’ commitment to innovation and providing Canadian children and their families living with cancer with greater access to the best and newest treatment that will assist to improve clinical care and quality of life.

Information on the referral to Sick Kids and the Patient Navigator Program can be found HERE. The Patient Navigator Program provides assistance to you and collaborates with your primary team in locating appropriate resources both in your own community and in the Toronto area to assist in your travel and stay in Toronto.

CAR T study now open: see the attached NAIT Sick Kids March newsletter for new activations and ongoing studies of interest

Find attached (here) the NAIT March Newsletter, listing the clinical trials available through the Clinical Trials and New Agent and Innovative Therapy (NAIT) Program at SickKids.

New Studies Activated

  1. CCTL019B2202: A Phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
  2. 1200.120:  Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of afatinib monotherapy in children with recurrent/refractory neuroectodermal tumours, rhabdomyosarcoma and/or other solid tumours with known ErbB pathway deregulation regardless of tumour histology.
  3. ADVL1412:  A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory

A list of all active NAIT studies can be found HERE.

The vision of the NAIT supports The Garron Cancer Centre and SickKids’ commitment to innovation and providing Canadian children and their families living with cancer with greater access to the best and newest treatment that will assist to improve clinical care and quality of life.

Information on the referral to Sick Kids and the Patient Navigator Program can be found HERE. The Patient Navigator Program provides assistance to you and collaborates with your primary team in locating appropriate resources both in your own community and in the Toronto area to assist in your travel and stay in Toronto.

3CTN Supporting Development of a ALL trial in the AYA Population

Adolescents and Young Adults (AYA) diagnosed with cancer have a unique set of challenges throughout their cancer journey and historically there have been limited formal clinical trials available to this population. To help support research in this important yet underserved segment of the Canadian cancer population, 3CTN is facilitating the development of a new clinical trial for the AYA population. The process began in the spring of 2015 with the release of a request for applications, which asked AYA researchers to submit clinical trial proposals.

Over the past few months, through a formal review and selection process, one project proposal for a trial in Acute Lymphoblastic Leukemia (ALL) was ultimately selected. On November 30 2015, 3CTN and our collaborators* held a workshop in Montreal, Quebec focused on developing this proposed pan-Canadian clinical trial. The workshop brought together principal investigators and site research staff from many Canadian pediatric and adult cancer centres with the common goal of launching a trial to address current knowledge gaps in AYA ALL therapy. Topics covered at the workshop included prioritizing the clinical needs of AYA ALL patients, identification of potential new agents and the status of the relevant diagnostic tests that will be required for a trial. A smaller working group will now focus on designing a draft protocol for a study to open within the next year. Clinical trials targeted to AYA with ALL will ultimately improve the standard of care and health outcomes for this population.

After the workshop, 3CTN provided a satisfaction survey and invited participants to provide feedback on the workshop. Nearly 70 per cent of attendees responded to the survey and indicated that overall, they were pleased with the workshop and that it met its stated goals and objectives.

The final goal of this AYA ALL trial development process will be a clinical trial in which Network centres can participate via the 3CTN Portfolio. Collectively our Network’s involvement may help decrease the knowledge gap in therapy for AYA Canadians diagnosed with ALL.

Would you like to understand why families decline participation in clinical trials? Read this press release to learn more about the BCCRIN anonymous survey for patients/families who have declined or participated in clinical trials.

 

Clinical researchers would like to learn about Canadian’s experience with clinical trials.

The Canadian Clinical Trials Coordinating Centre (CCTCC) is pleased to partner with the BC Clinical Research Infrastructure Network (BCCRIN) on the national expansion of the BC Clinical Trials Participation Survey. This survey recognizes the importance of engaging and learning from patients and the public about the clinical trial process. From the BC only data, researcher have found that patients/families that decline participation in clinical trials have a very different understanding of the clinical trial process than those that participated in a clinical trial.

Access the full press release here.

If you have participated in a clinical trial, were asked to participate and declined, or if you are the parent of a child who has been asked or has participated, your feedback is important to the future of research in Canada.

The anonymous survey can be accessed at: www.bccrin.ca/survey

C17 addendum: please note this survey does not appear to work in older browsers.

N2 November Newsletter Available

The N2 November newsletter is available and can be found here.

 

IT STARTS WITH ME! Clinical trial information website for patients launched by N2

Are you looking for a trustworthy website about clinical trials? Are you interested in learning about participating in a clinical trial? A new website (www.itstartswithme.ca/  www.cacommenceavecmoi.ca) about clinical trials was developed by patients and caregivers who have participated in a clinical trial or have had a loved one participate in a clinical trial and by people who work in clinical trials and research. The website tells you everything you need to know about clinical trials, things to think about or ask before you decide to participate, your rights as a person who is volunteering in a clinical trial, and has a glossary of terms for you. The site was created by the Network of Networks (N2– an organization that represents organizations that do clinical research and trials in Canada.

It Starts with Me has arrived! N2 is excited to announce the launch of its website created for the public to learn about clinical research and trials – www.itstartswithme.ca/  www.cacommenceavecmoi.ca! The site was developed with leadership from our Clinical Trials Education and Awareness Committee and also supported by a CIHR SPOR Patient Engagement Collaboration Grant that facilitated a valuable partnership with patients and caregivers to inform the site.

N2 hopes you will use this site in your work and we encourage you to link to the site, and/or place the link on your organization’s website. To help you spread the word about the site, N2 developed a template communication for you (first paragraph above) to share either internally with your own colleagues, or to post on your website and share in your own external communications.

It is important to N2 how the website is received and to ensure information is accurate and up to date. If you have any comments, questions or concerns, please provide us with feedback here. N2 is planning to develop and growth the website, for example with a video that is underway about clinical research, and some downloadable resources that are in production.

Online List of Clinical Trials Currently Available Through the Clinical Trials and New Agent and Innovative Therapy Program (NAIT) at SickKids’

Find below a list of of clinical trials available through the Clinical Trials and New Agent and Innovative Therapy Program (NAIT) at SickKids’.  The vision of the NAIT supports The Garron Cancer Centre and SickKids’ commitment to innovation and providing Canadian children and their families living with cancer with greater access to the best and newest treatment that will assist to improve clinical care and quality of life.

http://www.sickkids.ca/HaematologyOncology/nait/trials/index.html

Information on the the referral process to NAIT and the Patient Navigator Program can found on the left menu on the NAIT site.  The Patient Navigator Program provides assistance to you and collaborates with your primary team in locating appropriate resources both in your own community and in the Toronto area to assist in your travel and stay in Toronto.