Barriers and Solutions for the Expansion of Clinical Research in Latin America

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1 Barriers and Solutions for the Expansion of Clinical Research in Latin America A Pharmaceutical Company s Perspective E. Isola DIA S. Paulo Sep 06

2 Outline Regulatory Culture Ethical issues Sponsors Patients Investigators Institutions 2 Presentation Title / Name / Date

3 Regulatory Today (I) There are adequate regulations established in most countries. However, real life approval times are extended. Established timelines are frequently not respected Different evaluators make different interpretations Long trial start times, in an environment of competitive enrollment, usually result in most important trials being allocated in countries outside Latin America. 3 Presentation Title / Name / Date

4 Trial Start Times (Protocol to FPFV) Chile Republica Checa Brazil Argentina Dinamarca Malasia España Canada Suiza Guatemala Alemania Grecia Hong Kong Eslovaquia Taiwan 4 Presentation Title / Name / Date

5 Trial Start Times (Protocol to FPFV) 6 CVS trials in in Trial A Trial B Trial C Brazil Suiza Holanda Malasia Canada España Finlandia Austria Alemania Hong Kong Argentina Rusia Brazil Francia Turquia Uruguay Canada Eslovaquia Guatemala Argentina Chile Republica Checa Brazil Argentina Dinamarca Malasia España Canada Suiza Guatemala Alemania Grecia Hong Kong Eslovaquia Taiwan Trial D Trial E Trial F Venezuela Argentina Polonia Africa del Sur Rusia Guatemala Colombia Irlanda Dinamarca Italia Portugal Alemania España Turquia Inglaterra Australia Brazil Rusia Argentina Eslovaquia Guatemala Peru Taiwan Finlandia Colombia Francia Suecia Polonia Canada Alemania Italia Holanda USA Grecia Peru Brazil Ecuador Africa del Sur Rusia Francia Canada Egipto Argentina Hungria Finlandia Australia España Alemania Polonia Suecia 5 Presentation Title / Name / Date

6 Regulatory Today (I) There are adequate regulations established in most countries. However, real life approval times are extended. Established timelines are frequently not respected Different evaluators make different interpretations Long trial start times, in an environment of competitive enrollment, usually result in most important trials being allocated in countries outside Latin America. It is critical to find a solution to this growing problem through joint efforts among sponsors, health authorities, ethical review boards, institutions, investigators and scientific societies. 6 Presentation Title / Name / Date

7 Regulatory Today (II) Other barriers Collection of samples for genetic databanks will spread even more. Not enough inspections by qualified inspectors to sponsors and clinical investigator sites. 7 Presentation Title / Name / Date

8 Regulatory Moving Forward Future growth of clinical research will be fostered by: Harmonization of regulatory requirements (and its implementation) across Latin American countries. Health authorities and ERB s ability to meet the challenge of new clinical trials models (adaptive design). 8 Presentation Title / Name / Date

9 Culture There is a need to build an integrated clinical research culture among all stakeholders Regulatory authorities Patients, Sponsors, Investigators, Institutions, 9 Presentation Title / Name / Date

10 Culture There is a need to build an integrated clinical research culture among all stakeholders Regulatory authorities Patients, Sponsors, Investigators, Institutions, The key leading principle could be GCP compliance is necessary but not enough 10 Presentation Title / Name / Date

11 Ethical Review Boards Over the last few years there has been a rapidly growing number of ethical review boards. Most of them complying with GCP. It is critical that all ERBs impose a high standard of quality in their protection of trial subjects before, but also during and after the trial. Demanding progress reports and expedited notification of SAEs. Performing investigation sites audits Reviewing findings and acting upon them. This requires resources which can be obtained through adequate fees for protocol reviews and study follow up. 11 Presentation Title / Name / Date

12 Sponsors Need to respond to increasing demand for qualified and certified professionals through internal training. Could benefit from university-certified training programs on clinical research for MDs and monitors. 12 Presentation Title / Name / Date

13 Patients There are risks of high vulnerability Patients in Latin America usually place high trust on the investigator. Recruiting pressures might push investigators to marginal patient populations. There is a critical role of ERBs to protect patients. 13 Presentation Title / Name / Date

14 Investigators There is a need to understand Investigators needs and respond to them. 14 Presentation Title / Name / Date

15 Composite Sponsor Rating of Overall Relationship Quality, 2004 & 2005 Poor/Fair Neutral Good Excellent 100% 32% 39% 47% 41% 36% 36% 0% 20% 18% 13% 7% 7% 4% Europe United States Latin America Source: CenterWatch surveys of European (2004, n=340), U.S. (2005, n=612), and Latin American (2005, n=317) Investigative Sites 15 Presentation Title / Name / Date

16 The Top Five Essential Attributes to Study Success in in Latin America, 2005 Percent of Sites Rating Very Important 100% 85% 84% 83% 81% 79% 50% 0% Is organized and prepared Has professional, well-trained monitors/cras Provides good overall protocol design Has timely drug availability Maintains open communication Source: 2005 CenterWatch survey of 317 Latin American Investigative Sites 16 Presentation Title / Name / Date

17 The Top Five Problem Areas of Sponsors in in Latin America, 2005 Percent of Sites Rating 100% Essential Excellent 75% 60% 67% 66% 66% 67% 50% 37% 36% 37% 39% 25% 26% 0% Is flexible willing to modify protocols and budgets Provides fair overall grant payment amounts Offers realistic grant payment schedules Provides prompt payment of grants Has an efficient query handling process Source: 2005 CenterWatch survey of 317 Latin American Investigative Sites 17 Presentation Title / Name / Date

18 Investigators There is a need to understand Investigators needs and respond to them. There are many good MDs providing high quality clinical practice but with low clinical trial culture. Strong need for training Critical role of the trial coordinator High difference in price between HMO visit (USD 20) vs. Clinical Research visit (USD 200) is strong motivator to become trialist. High growth of SMOs with regulatory compliance but low clinical quality, e.g. Clinical charts shadowing CRFs. 18 Presentation Title / Name / Date

19 Institutions Institutions where clinical research is performed could help by assuming a more active role: Establish good quality IRBs which take care of trial progress overview. Generate more patient databases which facilitate screening of potential trial candidates and allow in silico trials. Ensure records retention. Establish clear guidelines for financial aspects and relationships with investigators. 19 Presentation Title / Name / Date

20 Conclusions Over the last 10 years clinical research activity has grown exponentially in Latin America. Future growth rates will probably be much lower. Efforts to increase quality in all aspects of clinical trials are key to future growth, not only in numbers of patients but also in complexity and scientific value. 20 Presentation Title / Name / Date

21 Obrigado Gracias Thank you

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