An Address From Dr. Richard Pazdur: How the Changing Landscape of Oncology Drug Development and Approval Will Affect Advanced Practice
A continuing education activity for nurse practitioners, PAs, clinical nurse specialists, advanced degree nurses, oncology and hematology nurses, pharmacists, and physicians.
Release date: January 26, 2018 Estimated time to complete activity: 1.0 hours
Expiration date: January 26, 2019
Richard Pazdur, MD
US Food and Drug Administration
Activity Rationale and Purpose
Approximately 40% of all drugs in development today are in oncology, and approximately 50% of all breakthrough therapies are in oncology. To expedite the drug development and approval process, a number of current and emerging initiatives are in place by FDA. They all take into account the many ways in which the increasing complexity of cancer is different from other therapeutic areas. For example, biomarkers are now selecting patients and driving treatments, and this has implications in both the clinics and in clinical trials. New approval pathways are helping move drugs into the clinic. These new processes enable the FDA to expedite drug development and approval, including early involvement of the FDA, sponsors, investigators, and patients in the discussion of clinical development plans.
The intended audience for this enduring internet activity is nurse practitioners, PAs, clinical nurse specialists, advanced degree nurses, hematology/oncology nurses, pharmacists, and physicians who specialize in the field of oncology.
After completing this educational activity, participants should be able to:
- Understand FDA regulatory principles with respect to trial design, end points, randomization, and accelerated approval programs
- Differentiate among various end points used in clinical trial design and understand their strengths and weaknesses
- Discuss emerging initiatives in the quest to expedite the drug development process
Statement of Credit—Participants who successfully complete this activity (including the submission of the post-test and evaluation form) will receive a statement of credit.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the joint providership of the Annenberg Center for Health Sciences at Eisenhower, the Advanced Practitioner Society for Hematology and Oncology, and the Journal of the Advanced Practitioner in Oncology. The Annenberg Center is accredited by the ACCME to provide continuing medical education for physicians.
The Annenberg Center for Health Sciences at Eisenhower designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Annenberg Center for Health Sciences is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
A maximum of 1.0 contact hours may be earned for successful completion of this activity.
Provider approved by the California Board of Registered Nursing, Provider No. 13664, for 1.0 contact hours.
This knowledge-based accredited education lecture is intended for pharmacists involved in the care of cancer patients. This educational activity is sponsored by the Annenberg Center for Health Sciences at Eisenhower.
The Annenberg Center for Health Sciences at Eisenhower is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program has been assigned ACPE Universal Program # 0797-9999-18-027-H01-P. This program is designated for up to 1.0 contact hours (0.10 CEUs) of continuing pharmacy educational credit.
All individuals in positions to control the content of this activity (eg, planners, faculty, content reviewers) are expected to disclose all financial relationships with commercial interests that may have a direct bearing on the subject matter of this continuing education activity. Participants have the responsibility to assess the impact (if any) of the disclosed information on the educational value of the activity.
Dr. Pazdur has nothing to disclose.
Lead Nurse Planner
Dorothy Caputo, MA, BSN, RN, has nothing to disclose.
Jeannine Coronna has nothing to disclose.
Claudine Kiffer has nothing to disclose.
Pamela Hallquist Viale, RN, MS, CS, ANP, has nothing to disclose.
Patricia McLafferty has nothing to disclose.
Chris Cherry has nothing to disclose.
Lynn Rubin has nothing to disclose.
Annie Yueh has nothing to disclose.
Dorothy Caputo, MA, BSN, RN has nothing to disclose.
Annenberg Center for Health Sciences at Eisenhower
John Bayliss, VP, Business Development, spouse is an employee of Amgen, Inc.; Charles Willis, Director, Continuing Education, consults for Pfizer Inc.; all other staff at the Annenberg Center for Health Sciences at Eisenhower have no relevant commercial relationships to disclose.
This activity has been designed to provide continuing education that is focused on specific objectives. In selecting educational activities, clinicians should pay special attention to the relevance of those objectives and the application to their particular needs. The intent of the Annenberg Center for Health Sciences, Harborside Medical Education, and JADPRO for all educational opportunities is to provide learning that will improve patient care. Clinicians are encouraged to reflect on this activity and its applicability to their own patient population.
The opinions expressed in this activity are those of the faculty and reviewers and do not represent an endorsement by Harborside Medical Education of any specific therapeutics or approaches to diagnosis or patient management.
This educational activity may contain discussion of published as well as investigational uses of agents that are not approved by the U.S. Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product.
How to Earn Credit
Statement of Credit: Participants who successfully complete this activity (including scoring of a minimum of 70% on the learning assessment and complete and submit the evaluation form) will be able to download a statement of credit.
- 1.00 ACPE
- 1.00 AMA PRA Category 1 Credit(s)™
- 1.00 Attendance
- 1.00 ANCC