International Clinical Trials

1. International Clinical Trials Dr. Luis A. Salicrup Senior International Cancer Research Specialist Center for Global Health National Cancer Institute National Institutes of Health

2. Importance of Clinical Trials • Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. • People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future

3. Clinical Research • Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following: • Who is eligible to participate in the trial • Details about tests, procedures, medications, and dosages • The length of the study and what information will be gathered • A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

4. Clinical Trials Protocol • Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

5. Types of Clinical Trials • Natural history studies provide valuable information about how disease and health progress. • Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things. • Screening trials test the best way to detect certain diseases or health conditions. • Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition. • Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. • Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.

6. Phases of Clinical Trials • Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects. • Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety. • Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely. • Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

7. Clinical Trials at NCI • The Cancer Therapy Evaluation Program (CTEP) supports organizations conducting cancer treatment trials through the Clinical Trials Cooperative Group Program. Emphasis is placed on the development and conduct of large, multicenter, randomized phase 3 studies. The program’s mission encompasses a wide variety of investigational efforts.

8. NCI’s Clinical Trials Cooperative Group Program • Is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life issues and rehabilitation during and after treatment. • Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe. • Efforts to include more LMICs • They work with NCI to identify important questions in cancer research and to design clinical trials to answer these questions

9. Clinical Trials Working Groups at NCI/NIH • COG - Children's Oncology Group • ECOG-ACRIN Cancer Research Group • NRG Oncology Group • NCI-CCTG - National Cancer Institute of Canada, Clinical Trials Group • SWOG - Southwest Oncology Group

10. Interactions with Industry • The goal of the Cancer Therapy Evaluation Program (CTEP) is to facilitate the process of bringing promising, novel, investigational anticancer and anti-HIV agents to the public as quickly and as safely as possible. • CTEP offers a unique combination of resources and expertise to assist an Industry Collaborator in clinical development of new therapeutic agents and the ability to evaluate investigational agents in a wide variety of tumor types and disease settings.

11. Important information about NIH Clinical Trials • www.clinicaltrials.gov

12. Useful Information about Clinical Trials • For those of you who want to learn about the policies and procedures involved in clinical drug development, CTEP has developed the Investigator's Handbook (now available online!). • If you want to find information on research and funding by NCI for AIDS-related malignancies, we have developed the Office of HIV AIDS Malignancy (OHAM) site for basic and clinical research.

13. For more information: • DCTD Links • Division of Cancer Treatment and Diagnosis (DCTD) Homepage • Biometric Research Branch (BRB) • Cancer Diagnosis Program (CDP) • Cancer Imaging Program (CIP) • Developmental Therapeutics Program (DTP) • Radiation Research Program (RRP) • Office of Cancer Complimentary and Alternative Medicine (OCCAM) • Clinical Trials Working Group (CTWG)

14. ASCO Clinical Trials Workshops • International Clinical Trials Workshop Application ICTW • To be held outside of the United States • Description: ICTW supports clinical cancer research by developing the research skills of • clinicians in emerging economy countries. The two-day intensive workshops are • organized and taught in conjunction with a national or regional oncology society. • Target audience includes young clinicians who have prior research experience but • limited research training and their supportive research staff (nurses, data • managers, CRAs, etc.). • The program focuses on best practices in the implementation of a clinical study • and includes an overview of clinical trial design, roles and responsibilities of the • research team, patient accrual strategies, ethical considerations, promoting clinical • trials, and regulatory issues. Content is delivered through a combination of • presentations and break-out sessions. The size of the workshop is small and • interactive.

15. ASCO-ICTW • Goal: Deliver education in globally accepted standards of conducting clinical cancer • research while remaining grounded in and relevant to the needs and interests of • the local audience and their setting. • ICTW Objectives: •  Further best practices in the implementation of research programs (patient • safety, global standards of GCP, promoting research, etc.) •  Increase understanding of local regulatory practices •  Increase understanding of roles and responsibilities of research team members •  Increase ability to communicate with patients the values of clinical research •  Enhance networking opportunities among researchers •  Increase participation in clinical trials long term (researchers/patients) •  Increase published research (long term)

16. ASCO ICTW • 1. Develop and list clear educational objectives for the workshop. Changes to the agenda after • approval is granted must be forwarded to ASCO International Affairs for review. • 2. Clearly define the target audience, sponsors, purpose and objective, program description, • agenda, and faculty. The local workshop director and members of the planning committee • must be identified. • 3. Submit a letter of support by an active ASCO member from the host country of the • conference. The letter must clearly state the goals of the workshop and reasons for which • the applicant organization is seeking collaboration with ASCO. • 4. Signatures of the local Workshop Director and Workshop Coordinator are required to apply • for ASCO ICTWs. These can be sent to ASCO by post, email, or fax for consideration. • 5. Following approval of the application by the International Affairs Steering Committee, an • ASCO member will be appointed to serve as ASCO Workshop Director and will be actively • involved in the content selection for the workshop. Applicant is encouraged to make • suggestions for ASCO members to serve in this capacity. ASCO may provide financial support • for the workshop, which will be determined on a case‐by‐case basis. • 6. If applying for financial support, a “Funding Request Form” must accompany this application.

17. ASCO Clinical Trial Workshops ICTW • Please detail speaker airfare and honoraria requests for funding. Also specify on this • application if funds are being requested from additional organizations other than ASCO. • 7. Applicant must comply with all the Legal Terms and Conditions Governing ASCO Advanced • Cancer Workshops attached to this application. Conference organizers will convey all criteria • to organizing committee members and faculty to insure full compliance. • 8. Submit original evaluation forms and a summary of the workshop within 45 days after the • conclusion of the program. These should include statistics on participants, feedback, and a • list of participant names and email addresses. • 9. Applicant may be granted permission to use the ASCO logo on promotional materials upon • request. All materials must be in accordance with the ASCO guidelines for logo use and • include the standard disclaimer found in the Legal Terms and Conditions Governing ASCO • International Clinical Trials Workshops. All materials must be pre‐approved by ASCO in • writing prior to their release. • 10.Organizers agree to comply with ASCO policies governing reproduction of ASCO content. • 11.ASCO adheres to the Council of Medical Specialty Societies (CMSS) • Please send the completed application and all required attachments listed in the application form to acc@asco.org.   • ASCO staff are available at international@asco.org to explain the application process and to answer any questions.  

18. Dr. Luis A. Salicrup • International Cancer Research Specialist • Center for Global Health • National Cancer Institute (NCI) • National Institutes of Health • salicrul@mail.nih.gov