The Clinical Trials Course 31st August-4th September 2009
Introduction
The clinical trial, the process by which a drug or medical device is tested for safety and effectiveness in human subjects, is the last stage in the development of new pharmaceutical products. Clinical trials require careful planning at every stage of the testing process to ensure safety human subjected to the new drug as well as accurate results. Success of clinical trials depends upon the interaction of highly trained professionals working for pharmaceutical companies that have manufactured the product, contract research organizations, and clinical study sites across the globe.
The demand for skilled professionals with specialized training in clinical trials has substantially grown over the years. Hence this short course in clinical trials is well placed and will help to meet this demand by providing comprehensive training to professionals already in the field or those intending to join the clinical trial field.
Who can participate?
Clinical research associates, study coordinators, or monitors working in the field who are looking for additional training.
Bench scientists in pharmaceutical companies who want to change careers within the industry.
Registered nurses who want to develop the skills to enter a new field.
Study coordinators who want more training in order to enter the wider clinical research associate employment market.
Other professionals who want to enter the field of clinical research, or who have been hired recently by academic study sites and need comprehensive training in clinical research.
Learning outcomes
* Learn current principles and practices in clinical research and research study design.
* Learn regulations, protocols and ethical standards governing clinical trials and testing on human subjects.
* Learn to plan and manage a clinical trial.
* Learn to apply statistical concepts to study design and evaluation of results.
* Achieve clarity and precision in reporting study outcomes.
* Understand the key elements of clinical trial design
* Able to determine appropriate sample sizes and power of the trial
* Fully understand ethical issues surrounding a clinical trial design
* Apply good clinical practice principles in the conduct of clinical trials
* Understand important data processing and data management issues
Course Structure
1. Basic epidemiologic concepts
The aim of this introductory session is to provide tools necessary to interpret and understand common concepts used in the field of epidemiology. Different measures of disease frequency and measures of association will be discussed and participants will gain insight in the calculation and interpretation of these measures. Also a broad overview of clinical trial conduct in Sub Saharan Africa will be highlighted.
2. Study designs and methods
The aim of this session is to give an overview of study designs used in epidemiologic studies and introducing the concept of randomized controlled trial design. In-depth learning will include the following areas:
i) Types of trial: Open trial & blind Trial
ii) Trial Phases: Phase 1-IV
iii) Blind Trials: Single, double-blind and triple€“blind trial
iv) Randomization procedures: Complete randomization, permuted block randomization, Urn randomization, Covariate-adaptive randomization and Outcome-adaptive randomization.
v) Allocation concealment
vi) Challenges: Statistical error, Blinding, outside pressure
3. Statistical concepts for clinical research
This session introduces basic statistical concepts and explains their particular relevance to clinical research design and monitoring. Topics include hypothesis testing, the meaning of p-value, power determination, randomization, stratification, crossover designs, non-randomized concurrent control studies and historical controls.
3. Clinical Trial Management
This session focuses on advanced strategic, operational, and project management topics in clinical research, with an emphasis on increasing efficiency and quality at all levels of the clinical trial process.
In this session topics include: managing timelines; assessing financial and regulatory implications; effective human resources allocation; developing and managing comprehensive clinical trials budgets; developing performance measures for tracking site and study performance; identifying and analyzing site performance problems; reporting and managing of adverse events; identifying various solutions and evaluating their feasibility; using new monitoring techniques; implementing site performance incentives, and the ethics of such incentives.
4. Clinical Data management
This session introduces participants to a clinical data management system which is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the clinical data management system. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method being double data entry.
Participants will also learn how to screen data for typographical errors and also how data can be validated to check for logical errors and how such errors can be corrected (e.g. checking the subject's age to ensure that they are within the inclusion criteria for the study). If errors are identified then they are raised for review to determine if there is an error in the data or clarification from the investigator is required.
Participants will also learn other functions that the clinical data management system can perform i.e. coding of data. For example, currently the coding is generally centered on two areas; adverse event terms and medication names. With the variance on the number of references that can be made for adverse event terms or medication names, standard dictionary of the terms can be loaded into the clinical data management system. The data items containing the adverse event terms or medication names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare it to the data dictionary. Items that do not match can be flagged for further checking.
5. Clinical Trial Monitoring
This session introduces participants to the process and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization, from the site initiation visit to the close out of a clinical study, focusing on regulatory issues and procedures.
Participants will learn the responsibilities of the IRB, sponsors, and investigators and also how will learn how to initiate a clinical research study.. Participants will learn how to apply routine monitoring methods throughout the process to verify data, monitor clinical supply and accountability on the study site, detect fraudulent patient information and data, identify and report adverse events, and monitor data collection methods (e.g., ordinary fax of CRF or data faxing CRF or remote data entry and to resolve data queries accurately and promptly.
Throughout the session, participants will learn the basics of communicating and negotiating with site coordinators and investigators, identifying and managing safety issues and addressing difficult study drug issues. Participants will also learn how to prepare site visit reports and assemble regulatory documentation and to conduct study close-out visits.
The course will run Monday to Friday from 31st August - 4th September 2009 from 8:00 a.m.-5:00 p.m.
The course fee is R5000 for external participants and R2500 for Wits staff and postgraduate students. Space is limited to 30 participants only on first come, first serve basis.
To register for this course, request for the registration from clinical trials course coordinator by email, fax or postage. Closing date for applications is 10th August, 2009. A limited number of scholarships are available for those seeking scholarships in part or in whole, closing date for scholarship applications is 15th July, 2009
For the registration form, please write to:
Course Coordinator,
School of Public Health, Faculty of Health Sciences,
University of the Witwatersrand,
7 York Road, Park Town,
Johannesburg, South Africa.
Tel: 27-11-717 2596, Fax: +27 11 717-2084 mailto:dinah.mataboge@wits.ac.za;