Memorandum of Understanding Between the American Statistical Association and the U.S. Department of Health and Human Services, Food and Drug Administration, Oncology Center of Excellence

I. Purpose

The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) and the American Statistical Association (ASA) agree to establish the FDA-OCE-ASA Oncology Educational Fellowship, as well as other collaborative educational efforts, as appropriate. The FDA-OCE and ASA share interests in promoting scientific progress through exchange of scientific knowledge in statistical methods for clinical research, oncology education, collaborative learning, and research. Both organizations foresee benefits from the mutual exchange of educational expertise in translational oncology drug development and regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for this Fellowship program and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning.

II. Background

The FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, the FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, the FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within the ASA will greatly contribute to the FDA’s mission.

The mission of the OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration. The OCE’s vision is to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer. The OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The OCE helps expedite development of medical products for solid tumors and hematologic malignancies and supports an integrated approach to their clinical evaluation. Proactive scientific education and collaboration with the ASA is consistent with the OCE’s vision and mission.

The mission of the ASA is to promote the practice and profession of statistics. Statistics contributes to the advancement of science and medicine across many domains. In support of the profession and the professionals who practice, the ASA is committed to the development and dissemination of knowledge through publications, meetings, and professional development initiatives. These undertakings along with advocacy efforts advance the ASA’s vision of a world that relies on data and statistical thinking to drive discovery and inform decisions.

The FDA and ASA intend to leverage their combined strengths for the joint development of the Fellowship, and other related efforts, to educate and provide career development for the selected
 
Fellows through collaborative learning and other training experiences, thereby fostering a greater understanding of oncology drug development and regulatory policy.

The OCE and ASA have complementary missions and rely on the expertise of statisticians and biostatisticians who are well-trained in the fundamentals of drug and diagnostic development and approval. Such individuals work in every sector, from academia to industry to government to clinical practice. This Fellowship and other joint efforts will help to fill an existing critical gap in statistical training, providing PhD candidates education relating to, among other things, regulatory science and the oncology drug approval process.

III. Substance of Agreement

This MOU is the foundation for the development of the FDA-ASA Oncology Educational Fellowship, as well as other educational initiatives between the OCE and ASA. The objective of these efforts is to educate Fellows about oncology drug development and regulatory policy.
Educational topics may include:

• Oncology drug regulation.
• The Investigational New Drug (IND) process.
• The New Drug Application (NDA) and Biologic License Application (BLA) process.
• Expedited drug development pathways.
• Statistical considerations in clinical trials throughout the drug development life cycle.
• Clinical trial design and efficacy endpoint considerations.
• Companion diagnostics, biomarkers, and precision oncology.
• Oncology disease area subject matters (patient-focused drug-development, real-world data and real-world evidence, targeted therapy, etc.).

The following individuals may apply for this Fellowship: PhD students in biostatistics or statistics programs who have passed their qualifying examinations or post-doctoral fellows in biostatistics or statistics who have specific interest in oncology drug development.

The FDA and ASA will jointly review the applications and select up to 20 Fellows per year, with a 6-month Fellowship duration, unless extended by joint agreement of the OCE and ASA. The majority of the Fellows will be PhD students, with the remainder being postdoctoral fellows.

Roles and Responsibilities of the Parties

• The ASA will be responsible for:
  • Jointly with FDA, determining the timeline for the program, for promoting the program, and for receiving applications and selecting Fellows
  • Advertisement and promotion of the Fellowship
  • Development of Fellowship application materials
  • Coordinating the Fellowship application process
  • Jointly with the OCE, deciding on the acceptance of Fellows
  • Jointly with the OCE, determining the educational agenda for the Fellows, especially the portions involving statistical methodology
  • Notification of accepted and not accepted Fellows
• The FDA will be responsible for:
  • Jointly with ASA, determining the timeline for the program, for promoting the program, and for receiving applications and selecting Fellows
  • Jointly with ASA, deciding on the acceptance of Fellows
  • Jointly with ASA, determining the educational agenda for the Fellows, especially the portions involving statistical methodology
  • Providing educational materials and teaching to selected Fellows on regulatory policy and oncology drug development, using only publicly available documents and materials.

The fellowship program will be conducted online. No in-person meetings are anticipated.

The sharing of non-public information is not permitted under the terms of this MOU, including FDA non-public information, confidential commercial and/or trade secret information in FDA’s possession, and/or ASA non-public information, OCE staff participating in this Fellowship program, or in other joint educational efforts with ASA, including interacting with Fellows, shall not further release, publish, or disclose FDA non-public information, and/or or confidential commercial or trade secret information, and they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of privileged information.

IV. Promotional Activity

The ASA has no commercial products or commercial services and will not use the Fellowship as a vehicle to sell or promote commercial products or commercial services. The use of the FDA and/or ASA logo will be consistent with the FDA and ASA’s logo policies.

V. Fellowship Publicity and Endorsement

The ASA agrees not to use the name of the FDA or any of the FDA components, except in factual publicity for the Fellowship. Such factual publicity shall not imply that the involvement of the FDA serves as an endorsement of the general policies, activities, or products of the ASA. Where confusion could result, publicity should be accompanied by a disclaimer to the effect that no endorsement is intended. The ASA will clear all publicity materials with the FDA to ensure compliance with this paragraph.

VI. Termination

Non-adherence to the terms of this agreement may result in the ASA or FDA terminating the agreement.

VII. Resource Obligations

This MOU represents the broad outline of the FDA and ASA’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against either Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. Separate additional educational activities may be planned (e.g., workshop, lectures, etc.).

VIII. Liaison Officers

For the ASA:
Donna LaLonde
American Statistical Association
732 N. Washington St., Alexandria, VA 22314 Phone: 703-684-1221
Email: donnal@amstat.org

For the FDA/OCE:
Jennifer Gao, M.D.
Oncology Center of Excellence Building 22, Room 2135
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Email: jennifer.gao@fda.hhs.gov

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

IX. Terms, Termination and Modification

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until September 30, 2028 and may be modified or terminated by mutual written consent of the Partners or may be terminated by either Partner(s) upon a 14- day advance written notice to the other.

Approved and Accepted by the American Statistical Association

/s/
Ronald L. Wasserstein, Ph.D.
Executive Director, American Statistical Association
Date: 05/15/2023

Approved and Accepted by the Food and Drug Administration

/s/
Richard Pazdur, M.D.
Director, Oncology Center of Excellence
Food and Drug Administration
Date: 06/06/2023