Thursday, September 11

Transcription

1 WORKING AGENDA INTERNATIONAL CLINICAL TRIAL WORKSHOP September Hotel Sheraton L Sierr Saloon, Córdoba, Argentina Chairs: Lucia Delgado, Guadalupe Pallota, Eduardo Richardet Thursday, September 11 7:30 a.m. Registration Lobby Registration Desk 08:00 am 30 minutes 8:30 am Welcome and Introduction :Eduardo.Richardet ASCO: Suanna Bruinooge : Larry Rubinstein & Sherry Ansher : Barb Ljubeko AOCC: Florencia Perazzo 8:30 am 60 minutes 9:30 am Overview of Cancer Issues in Latin America : () Jorge Madrid Jorge Gallardo 1. Epidemiological patterns of cancer and cancer registries in Latin America (LA) (). 2. The importance of epidemiological studies () 3. Clinical research in latinamerica () 1-Eduardo Richardet(15 min) 2-Guadalupe Palotta(15 min) 3- Lucia Delgado(15 min) 4-All 15min 9:30 am 30 minutes 10:00 am Academic clinical trials in Latin America. Importance and main challenges Coordinator: Lucia Delgado Eduardo Richardet 1. Academic perspective (). 2. Government view () ANMAT. 1-Jorge Madrid (15 min) 2-Miravet Marcela(15 min) 10:00 am 15 minutes 10:15 am Break of 8/27/ :54 a.m.

2 10:15 am 60 minutes 11:25 am Funding sources & Perspective of sponsors : Florencia Perazzo Eduardo Richardet 1. Overview of Funding Sources. 2. Academic perspective 3. Government perspective a. LA- INC Argentina (Argentina). b. USA (5 min) 4. Cooperative group perspective a. (5 min) b. (5 min). 5. Industry perspective. 6. Discussion Panel - All (30 min) 11:25 am 60 minutes 12:25 pm Role of the oncology research team : Jose Zarba (Argentina)- Guadalupe Pallota. 1-Role and Responsibilities of the PI on the Team. 2. Biostatistician and Bioinformatics (). 3. Clinical Research; Associate/Research; nurse/nurse/resident;pharmacist/supportive staff (administrative)/data Manager/Data Entry/Trial participant according to GCP (). 1-Adriana Foltan(10 min) 2-Jorge Gallardo(5 min) 3-a) LA-INC Eduardo Cuest (5 min) b) Sherry Ansher (5 min) 4- a) Sherry Ansher (5 min ) b)betina muller (5 min) 5- Mariana Fernandez (5 min) 6- Discussion (20min) agregados a panel Marcela Paz Videla Roberto Gomez Leandro Linarello Mariano Carrizo 1-Gail Eckhardt (10 min) 2-() Rubistein (10 min). 3-Carmen Jacobs (20 min) 4- All (20min) Question & Answer (20 min) 12:25 pm 95 minutes 2:00 pm Lunch 2:00 pm 75 minutes 3:15 pm Ethical Considerations Coordinator: Hugo Vilarodona (Serfis) - Bettina Muller (Gochi) 1. Tenets of Good Clinical Practice. 2. International standards for informed consent 3. Availability of drugs before and after the trial () 4. Conflict of interests relevant to clinical research () 5. Discussion Panel 3:15 pm 30 minutes 3:45 pm Reading the literature on clinical trials with a critical eye: recognizing and learning from the mistakes of others 3:45 pm 15 minutes 4:00 pm Break 1-(10 min) 2-(10 min) 3-Sherry Ansher (15 min) 4-Eduardo Cuest (15 min) 5-All (20min) Ian Tannock (30min) of 8/27/ :54 a.m.

3 4:00 pm 90 minutes 5:30 pm Clinical trial Design and Methodology (I) 1. Developing a hypothesis from a clinical observation 2. Developing a protocol design. a) Phe I trials b) Phe II trials c) Phe III trials 3. Defining the population and eligibility criteria. Primary and secondary endpoints. RECIST criteria. Evaluation and recording of toxicity. 4. Patient reported outcomes and quality of life. 5. Role and responsibility of Ethics Committee/IRB and ethical considerations about biologic samples in clinical studies. 6. Question & Answer 5:30 pm 90 minutes 7:00 pm Interactive session Group discussions of protocols phe I, II, III Main facilitators: Gail, Ian, Lucia, Alvarez Co-facilitators: Guillermo Lerzo, Gadalupe Pallota (Argentina). 1- Ian Tannock(10min) 2-a) Gail Eckhardt (15min) b) Dr. Alvarez (15min) c)ian Tannock (15min) 3- Ian Tannock(10min) 4- Ian Tannock (10min) 5- Ricardo Alvarez (10min) 6-Question &Answer (5min) All faculty and students (90min) 7:00 pm Opening Ceremony & Welcome Reception Friday, September 12 8:00 a.m. 120 minutes 10:00 a.m. Clinical Research Design and Methodology (II) : Claudio Martin, Jorge Madrid 1. Sample size. Type I and type II errors. Survival analysis. 2. Generating a hypothesis, systematic review and meta-analysis, prognostic and observational studies. 3. Defining roles and responsibilities of each party in co-sponsored or collaborative studies. 4. Quality of life, patient-reported outcomes and cost effectiveness 5. Question & Answer 1 -Larry Rubinstein (20 min) 2-Ian Tannock (20 min) 3-Gail Eckhardt (20 min) 4-Ian Tannock (20 min) 5-All (40min) of 8/27/ :54 a.m.

4 10:00 a.m. 120minutes 12:00 p.m. Interactive breakout groups need local cofacilitators Group 1: Developing a viable early phe research proposal. Deciding the project, objectives, draft writing, systematic review. Gail Eckhardt, Guillermo Lerzo Group 2: Implementation of the project: Site selection, the multidisciplinary team, Training. Ricardo Alvarez Eduardo Cuest. Group 3: Project management: How to enhance enrollment, source data collection, data management, SOPs, and follow-up. Carmen Jacobs; Guadalupe Palotta Group 4: Developing a viable late phe research proposal. Deciding the project, objectives, draft writing, systematic review. Ian Tannock, Lucia Delgado All faculty and students 20min for group. (Coffee Break indoors during this session). 12:00 p.m. 1:00 p.m. Lunch 1:00 p.m. 2:15 p.m. 2:15 p.m. 70 minutes 3:25 p.m. Regulatory Issues: Coordinadores: ANMAT- COEIS Carina Olmos - Eduardo Richardet 1. International perspective (20 min) - International considerations for multi-site trials - Generally accepted standards for clinical trial approval - Safety and surveillance reporting for adverse events, coding, etc. - International insurance requirements for patients. Intellectual Property & Technology Transfer Issues 2. Regional perspective (20 min) - Legal pects of clinical trials (patients, investigators, sponsor) and reporting requirements of local regulatory bodies - New regulatory laws in Latin America - Approval process for use/importation of drugs and approval process for sending human samples abroad 3. Regulatory process in argentina 4. Discussion Panel 1- Sherry Ansher (15 min) 2-Mauricio Cuello (15 min) 3-Carina Olmos (15min) 4-All (25 min) of 8/27/ :54 a.m.

5 3:25 p.m. 15 minutes 3:40 p.m. Break 3:40 p.m. 60 minutes 4:40 p.m. Planning and Surviving an Audit. Sponsors expectations vs academic expectations : Santiago Bella- Norma Pilnic 1. Minimum Standards and Exemplary Attributes of Clinical Trial Sites - 2. How to plan and survive a formal audit, monitoring visits. a. Clarification of sponsor role b. Adherence to protocol and SOPs c. Regulatory compliance 3. Question & Answer 4:40 p.m. 55 minutes 5:35 p.m. Selecting a multi-site Clinical Trial to Activate : Martinez Felipe Batagel Emilio 1. Financial & Logistical feibility a. Elements of a budget required human/physical resources b. Sources of funding (government, charity, academic/institutional) c. Planning for costs not covered by study sponsors d. Contract negotiation skills e. Responsibility of patient care costs 2. Discussion Panel. 5:35 p.m. 25 minutes 6:00 p.m. Biomarker Translation (or something similar about translating research) Coordinator: Jorge Gallardo 1-Gail Eckhardt (20 min) 2-Carmen Jacobs (20min) 3-All (20min) 1-a)Ricardo Alvarez (20min) 2-All (15min) Gail Eckhardt Saturday, September 13 8:30 a.m. 30 minutes 9:00 a.m. Public Policies to encourage scientific research () 9:00 a.m. 40 minutes 9:40 a.m. Impact of Clinical Trials on Cancer Care in Low- and Middle-Income countries Coordinator:Eduardo Richardet () Ingrid Strusberg 1-Current situation of clinical cancer research 9:40a.m. 20 minutes 10:00 a.m. Break Eduardo Cuest (30min) Lucia Delgado (20min) 1-Ricardo Alvarez (20 min) of 8/27/ :54 a.m.

6 10:00 a.m. 60 minutes 11:00 a.m. Publishing Research Findings Coordinator: Eduardo Richardet Jorge Gallardo. 1. Publishing and presenting your data a. Developing principles for authorship and data sharing in a multi-site trial b. How to write a clear and concise scientific abstract and paper 1-Ian Tannock (20min) 2-Eduardo Cuest (20min) All (20min) 2. How to be successful in publishing your work. a. How to select a relevant journal for publishing b. How to respond to editorial critiques 11:00 a.m. 55 minutes 11:55 a.m. Opportunities and main challenges faced by clinical researchers in LA. Young oncologist investigator s vision Coordinator: Martin Richardet- Diego Kaen Mauricio Cuello (Uruguay 15min). Rachel Riechelmann (20min). All (20min) 11:55 a.m. 15 minutes 12:10 p.m. Closing Remarks 12:10 p.m. of the Workshop - Certification of 8/27/ :54 a.m.