Role of the Oncology Research Team

1. Role of the Oncology Research Team

2. Objectives • To get familiar with the different participants of the oncology research team • To identify the role of the participants • To emphasize the absolute need of working together to achieve the final objective. Generate reliable and robust data that help our patients

3. Oncology Research Team • Principle Investigator • Protocol Chair • Co-Investigators • CRA • Biostatistician • Radiologists, Radiation Oncologist, Surgeons • Pathologists, Pharmacist, Clinical Pharmacologist • Support staff • Research Base

5. Principle Clinical Investigators • Any physician who assumes full responsibility for: • Writing the protocol document • Obtaining the necessary approvals (IRB, sponsor, etc) • The treatment and evaluation of patients on research protocols • The integrity of the research data • Seeing that protocol is followed and the data collected • Monitoring the study • Analyzing results • Reporting results to the sponsor and medical community. Positive and/or negatives

6. Principal Investigator as Team Leader • Has MANY roles • Advocates for scientific process • Educates physician scientists, research staff and community • Point person for data managers • Ethical monitor regarding clinical trials offered at site • Leads and manages • Sets tone for the research enterprise • Signer of 1572 and assumes associated obligations

7. FDA Form 572 • The clinical trial will be conducted accordingly to ethically and scientifically sound principles • A properly constituted IRB will be responsible for the initial and continuing review and approval of the study • Proper and secure storage of the investigational agent. Adequate agent accountability records • Promptly reporting adverse events • Investigator provides a statement of the education and experience which qualify him or her to conduct the study

8. Principal Investigator as Team Leader (II) • Role model: if the PI is not committed then neither will staff • Cheerleader • The “Manager” of customer service • Chooses clinical trials for the program • Assures program financial integrity and viability is intact • Builds bridges…. • The Principal Investigator Can NOT work alone; the Team is what makes a research program successful

9. Commitment is what transforms a promise into realityAbraham Lincoln

10. Biostatistician • Method of randomization and stratification • Sample size justified for adequate testing of primary and secondary hypotheses • Error levels • Differences to be detected for comparative studies • Size of the confidence interval • Stopping guidelines, including statistical and administrative procedures for monitoring the progress of the trial to implement early termination

11. Radiology-Imaging • Team member • Educate and communicate regarding protocol specific requirements • Make it simple, develop templates for protocol patients and required reads • New and complex role in developing imaging tools including biomarkers

12. Surgeons • Key member of the team • Communicate and educate protocol specific requirements: timing of surgery in relation to protocol therapy, ie bevacizumab in neoadjuvant therapies • This is a relationship that may improve oncologic surgical care • Need to coordinate biospecimen collection with research nurses/data managers

13. Pathologist • Get them involved and committed to your mission • Discuss pathology requirements of protocols with them-does the study make sense for your community? • Engage them as a team member • Support the pathologist’s activities with education and communication with their administrators • Needed for tissue submission or special requirements for processing biologic specimens

14. Lab Personnel • Needed to get labs done for the trial • Avoid lost data ( EMR should help with this once perfected) • Good communication • Trained personnel

15. Physician Investigator- Community Dr. • Necessary and highly regarded point of contact for the patient • The physician must believe in clinical trials for your program to succeed • Patients will not enroll on clinical trials if the physician advises against it • Need to keep clinical trials in the forebrain of the physician : visibility of CRAs, protocol lists, marketing techniques

16. Physician Investigator-Community Dr. • Have dedicated research staff available to support the physician and minimize as many of the barriers possible for accrual, enrollment, delivery of protocol therapy, follow-up, etc. • Engage the physician as a critical team member empowering them to deliver the highest standard of care to their patients through clinical trials by providing a trial menu that makes sense for your site, providing infrastructure, education and applaud /acknowledge their success

17. Physician Barriers • Physician participation is discouraged by: • Increased time and effort to find a trial • Establish eligibility • Explain the trial to the patient • Obtain informed consent • Perform additional work associated with study • Comis, et al. JCO 21(5) 2003: 830-835

18. Summary • Team work is vital • As a team we have the ability to heal far beyond any singular effort

19. CTEP Visiting Physician ExternshipCoordinator: Igor Espinoza-Delgado, M.D.

20. Activities for Physicians Visiting CTEP • Visiting physicians (VPs) are involved in the day to day operations of CTEP • In close collaboration with Sr. Clinical Investigators, VPs will be asked to: • Be present for internal meetings and for discussion between CTEP and pharmaceutical companies in evaluation of new agents • Participate in discussions between CTEP and FDA regarding the development of new agents

21. Activities for Physicians (II) • Observe concept reviews in which prioritization of cooperative group phase III clinical trials are taken • Former VPs have reported that a CTEP rotation has provided them with crucial insights for preparing successful LOIs and for preparing and conducting clinical trials.

22. Investigational Drug Branch Responsible for: • Implementation and monitoring of a comprehensive cancer therapy clinical program that sponsors clinical trials of novel agents that have demonstrated high activity in relevant pre-clinical models. • Creation of drug development plans (Phase I, II, and III trials) for anti-cancer drugs and coordination of both intramural and extramural investigators and the pharmaceutical industry in the design and the conduction of these trials.

23. The Clinical Investigation Branch • Responsible for: • Scientific and administrative coordination of the Clinical Trials Cooperative Group Program • Development, organization, and scientific review of investigational programs to evaluate the comparative effectiveness of specific types and methods of cancer therapy, including curative and adjuvant therapy • The collection, banking, and use of clinical specimens and the coordination of procedures for utilizing these specimens • International clinical trials organization liason activities and the coordination of international planning for phase III trials • The development of research standards and harmonization of research methodologies (such as outcome criteria and novel clinical trials designs) in collaboration with Clinical Trials Cooperative Groups, consortia, cancer centers, and other entities

24. Current CTEP Workload • Average # of documents received per month over the last 5 months: • Concepts - 6 • LOIs – 16 • Protocols – 21 • Revisions – 55 • Amendments - 193 • As of May 2010, there are approximately 1145 ongoing CTEP sponsored studies

25. GRACIAS!

26. Prepared by: Igor Espinoza-Delgado, M.D. Robin Zon, MD, FACP Marge Good, RN, BSN, MPH, OCN Wichita CCOP

27. Elements of Success • Committed Staff • Financial Resources • Accessible Ancillary Services • Respect for Subjects • Host Institution Support • Emphasis on Safe Patient Care • (C-Change & Coalition of Cancer Cooperative Groups; 2007)