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1. Multinational Clinical Trials And Investigator Initiated Studies Diego Glancszpigel, Corporate Vice President, PAREXEL International
October 22nd, 2009
2. 2 Agenda
Growth of clinical trials World Wide and in Latin America.
What is expected from a reliable investigational site ?.
Investigator initiated studies.
3. 3 Outsourced Clinical Research is Accelerating Globally
5. 5 Clinical Trials Distribution in Latin America
6. 6 Notes_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Notes_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
7. 7 Growth of participation in Clinical Trials from 2005 to 2008 (*Year clinical trial first submitted to ClinicalTrials.gov)
10. 10 Latin America Quality Progress
11. 11 What is expected from a reliable investigational site ? Make decision with the patient in mind !!!
Not hide any mistakes made during the execution of the clinical trial.
Rapid ethics committee review.
Adequate site facilities (supplies storage, equipment validation, secure place to store study documentation, etc).
Dedicated staff trained on GCP.
Appropriate patient consent process.
Detailed patient records.
On time safety reporting.
High patient recruitment rates.
12. Investigator Initiated Studies
13. 13 A unique opportunity to do research Studies sponsored by the Pharmaceutical Industry to develop new research ideas.
This is an opportunity to generate more research opportunities within an Institution.
The main challenge of this initiative is to present well founded ideas that can generate add value to Patients and Pharma Industry.
14. 14 To find a link between your interest and the Sponsor one.
The Sponsor is interested in documenting something about the product that nobody said before.
Identify additional product benefits
Identify product additional benefits compare against other products in the same indication
Identifying sub-populations that can be benefited by the product
New product indications
Introduce a well written protocol including all relevant infomation required for EC and Ministry of Health approval (A well founded plan is critical for success).
Some tips to submit an Investigator initiated study