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Rare Disease Clinical Trials: Researching Clinical Trial Opportunities for Patients

Rare Disease Clinical Trials
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This is the first module in the “Rare Disease Clinical Trials” program.

Provided by

Support for the activities in this curriculum has been made possible through educational grants from Sanofi Genzyme, Grifols, Novocure, and Ultragenyx Pharmaceutical.

Course Description

When caring for an individual with a rare disease who has exhausted standard treatments or for whom there are no treatments available, exploration of clinical trials, and possibly expanded access programs, may be warranted. However, many care team members and their patients may not know where to begin with these options. In addition, a number of barriers to participation may exist for both the patient and the care team. Clinicians caring for people with rare diseases, therefore, would benefit from education about how to find appropriate trials for their patients with rare diseases, and how to overcome patient and team barriers to participation.

Learning Objective

After participating in the activity, learners should be better able to:

  • Identify potential clinical trials and/or expanded access programs for your patients with rare diseases

Release date: 11/30/19
Expiration date: 11/30/20
Estimated time to complete: 0.25 hours

Activity Faculty

Heather Lau, MD, MS
Director, Lysosomal Storage Disorders Program
Associate Director, Division of Neurogenetics
Department of Neurology
NYU School of Medicine
New York, NY

Target Audience

The target audience for this initiative is physicians, nursing professionals and other members of the team caring for persons with rare diseases.

Accreditation and Credit Designation

In support of improving patient care, American Academy of CME, Inc. is Jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

American Academy of CME, Inc., designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Academy of CME, Inc., designates this educational activity for 0.25 ANCC contact hours.

Method of Participation

There are no fees to participate in the activity. Participants must review the activity information including the learning objectives and disclosure statements, as well as the content of the activity. To receive CME/CE credit for your participation, please complete the brief post assessment and evaluation. Your certificate can be available immediately.

Disclosure Statement

According to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation. All educational materials are reviewed for fair balance, scientific objectivity and levels of evidence. Disclosures are as follows:

Dr. Lau discloses the following relationships:
Advisory Board: Amicus Therapeutics, Adult Polyglucosan Body Research Foundation, Biomarin, Chiesi, Enzyvant, National Tay-Sachs & Allied Diseases Association, Sanofi Genzyme, Takeda
Honoraria: Actelion, Amicus Therapeutics, Biomarin, Chiesi, Enzyvant, Fabry Support and Information Group, Muscular Dystrophy Association, National Gaucher Foundation, Sanofi Genzyme, Takeda, Ultragenyx Pharmaceutical
Consulting: Actelion, Amicus Therapeutics, ASPA Therapeutics, BioMarin, Chiesi, Pfizer, Prevail Therapeutics, Sanofi Genzyme, Takeda, Ultragenyx Pharmaceutical
Grant/Research Support: National Tay Sachs & Allied Diseases Association, Sanofi Genzyme, Amicus Therapeutics, BioMarin, Mallinckrodt, Pfizer, Protalix, Sangamo, Sanofi Genzyme, Ovid Therapeutics, Takeda, Ultagenyx Pharmaceutical

Planners have no relevant relationships to disclose.

Disclaimer

This activity may contain discussion of off-label or investigational information.

The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.

Hardware/Software Requirements

Windows Requirements: • Operating system: Windows XP Service Pack 2 or later • Browser: Internet Explorer 7 or later, Mozilla Firefox 2.5 or later • Internet connection: DSL, cable modem, or other high-speed connection

Macintosh Requirements: • Operating system: Mac OS X v10.3 or later • Browser: Mozilla Firefox 2.5 or later • Internet connection: DSL, cable modem, or other high-speed connection

Privacy

For more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm

For more information about CheckRare’s privacy policy, please access https://checkrare.com/privacy/

Contact

For any questions, please contact: CEServices@academycme.org

Copyright

© 2019. This CME/CE-certified activity is held as copyrighted © by American Academy of CME, Inc. Through this notice, the Academy grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

Rare Disease Clinical Trials: Researching Clinical Trial Opportunities for Patients

Program: Rare Disease Clinical Trials

Slides

Rare Disease Clinical Trials Module 1 slides

Resources

ClinicalTrials.gov. National Library of Medicine www.Clinicaltrials.gov

Talking to Your Patient About a Clinical Trial. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/talking-your-patient-about-clinical-trial

Educational Resources on Clinical Trials. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/educational-resources

  • Information About Children and Clinical Research Trials
  • Information for Seniors
  • Information en Español
  • Precision Medicine in Research
  • Sex and Gender in Research
  • Diversity in Research
  • Types of Clinical Studies

Glossary of Common Terms Associated with Clinical Trials. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-terms

Information about Expanded Access Programs. Food and Drug Administration. https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians

Rare Disease Clinical Trials: Researching Clinical Trial Opportunities for Patients

Program: Rare Disease Clinical Trials

Provided by

Support for the activities in this curriculum has been made possible through educational grants from Sanofi Genzyme, Grifols, Novocure, and Ultragenyx Pharmaceutical.

Course Description

When caring for an individual with a rare disease who has exhausted standard treatments or for whom there are no treatments available, exploration of clinical trials, and possibly expanded access programs, may be warranted. However, many care team members and their patients may not know where to begin with these options. In addition, a number of barriers to participation may exist for both the patient and the care team. Clinicians caring for people with rare diseases, therefore, would benefit from education about how to find appropriate trials for their patients with rare diseases, and how to overcome patient and team barriers to participation.

Learning Objective

After participating in the activity, learners should be better able to:

  • Identify potential clinical trials and/or expanded access programs for your patients with rare diseases

Release date: 11/30/19
Expiration date: 11/30/20
Estimated time to complete: 0.25 hours

Activity Faculty

Heather Lau, MD, MS
Director, Lysosomal Storage Disorders Program
Associate Director, Division of Neurogenetics
Department of Neurology
NYU School of Medicine
New York, NY

Target Audience

The target audience for this initiative is physicians, nursing professionals and other members of the team caring for persons with rare diseases.

Accreditation and Credit Designation

In support of improving patient care, American Academy of CME, Inc. is Jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

American Academy of CME, Inc., designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits&trade. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Academy of CME, Inc., designates this educational activity for 0.25 ANCC contact hours.

Method of Participation

There are no fees to participate in the activity. Participants must review the activity information including the learning objectives and disclosure statements, as well as the content of the activity. To receive CME/CE credit for your participation, please complete the brief post assessment and evaluation. Your certificate can be available immediately.

Disclosure Statement

According to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation. All educational materials are reviewed for fair balance, scientific objectivity and levels of evidence. Disclosures are as follows:

Dr. Lau discloses the following relationships:
Advisory Board: Amicus Therapeutics, Adult Polyglucosan Body Research Foundation, Biomarin, Chiesi, Enzyvant, National Tay-Sachs & Allied Diseases Association, Sanofi Genzyme, Takeda
Honoraria: Actelion, Amicus Therapeutics, Biomarin, Chiesi, Enzyvant, Fabry Support and Information Group, Muscular Dystrophy Association, National Gaucher Foundation, Sanofi Genzyme, Takeda, Ultragenyx Pharmaceutical
Consulting: Actelion, Amicus Therapeutics, ASPA Therapeutics, BioMarin, Chiesi, Pfizer, Prevail Therapeutics, Sanofi Genzyme, Takeda, Ultragenyx Pharmaceutical
Grant/Research Support: National Tay Sachs & Allied Diseases Association, Sanofi Genzyme, Amicus Therapeutics, BioMarin, Mallinckrodt, Pfizer, Protalix, Sangamo, Sanofi Genzyme, Ovid Therapeutics, Takeda, Ultagenyx Pharmaceutical

Planners have no relevant relationships to disclose.

Disclaimer

This activity may contain discussion of off-label or investigational information.

The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.

Hardware/Software Requirements

Windows Requirements: • Operating system: Windows XP Service Pack 2 or later • Browser: Internet Explorer 7 or later, Mozilla Firefox 2.5 or later • Internet connection: DSL, cable modem, or other high-speed connection

Macintosh Requirements: • Operating system: Mac OS X v10.3 or later • Browser: Mozilla Firefox 2.5 or later • Internet connection: DSL, cable modem, or other high-speed connection

Privacy

For more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm

For more information about CheckRare’s privacy policy, please access https://checkrare.com/privacy/

Contact

For any questions, please contact: CEServices@academycme.org

Copyright

© 2019. This CME/CE-certified activity is held as copyrighted © by American Academy of CME, Inc. Through this notice, the Academy grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

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