Katie Margules, BS, MSc, Senior Director, Project Management, Latin America, Clinical Development Services, COVANCE INC
Jacqueline Mardell, Formerly Senior Director of Clinical Operations, METABOLEX INC.
Nagaraja Srivatsan, VP & Head of Life Sciences, North America, COGNIZANT TECHNOLOGY SOLUTIONS
Presentations were given by four panel members that covered all aspects of conducting clinical trials in emerging countries/regions. The specific regions discussed were Russia, Latin America and India. These detailed discussions included regulatory and ethical considerations when conducting studies in these parts of the world. The key points for each region is as discussed below.
The approval process in Russia includes both the ethical as well as the regulatory component that is sent to the Ministry of Health, State Pharmacological Committee.
Russia is attractive as a region to conduct clinical studies as there are 11 cities with from 1 to 10 million people with a significant number of patients for treatment purposes.
There have been Federal Laws that have been enacted in 7/93, 6/98, 12/98 and 6/03 that specifically discuss the Rules for Clinical Research.
Sponsors are going to Russia due to lower costs and readily available patients.
FDA results are good in Russia with respect to compliance issues.
Study start up times are comparable to US and other countries where the quality is good. Georgia is an emerging market for clinical trials and interested parties are encouraged to initiate these studies in this region sooner rather than later. A caveat to consider is that the approval process can be slow in Russia.
Latin America (LA)
The major markets in LA are Brazil, Mexico, Colombia, Argentina, Peru, Chile (17-190 million) Guatemala, Dom Republic, Nicaragua, Costa Rica, Panama Puerto Rico (4 – 13 Million).
There are numerous special populations for specific diseases in Central America as well as experienced key opinion leaders (KOL).
Advantages I -Conducting clinical trials in LA
Populations are concentrated in fewer and larger cities than US or Europe.
There are primarily two languages in LA and they are, Portuguese and Spanish.
There is a shorter development process of drugs treating seasonal diseases in LA. There can be a higher incidence of some diseases in some countries and one can have better access to naïve patient populations.
There are fewer competitive trials within a given country in LA.
Monitor’s academic credentials equal or better than in US or Europe.
Advantages II – Patients willing to participate in clinical trials
Critical Success Factors – Sponsors are encouraged to speak with regulators frequently, to get a commitment from each country to work with sponsors and to implement what is needed to meet guidelines and changing environments.
- Free medication
- No difficulties in getting appointments
- No waiting room delay
- Excellent patient/doctor relationship (improves retention rate)
- Frequent and easier communication between sites and monitors
- Investigators eager to participate in clinical trials
- Provides alternatives for financial support
Each country has unique cultures, doctor patient relationship, healthcare systems, standard of care, increased monitoring frequency and communication.
Critical Success Factors II – Numerous activities need to occur in order to be successful in LA. Among them are to have a clear development strategy (study designs), address issues associated with the importation of clinical supplies early in the process, obtaining the appropriate licenses, translations of key documents in the local language and addressing required safety reporting standards.
Some countries in the LA region may suffer from social, economical political unrest during clinical study. One needs to be diligent in knowing the cultural, social and political issues in the countries of interest.
LA has done about 5000 clinical trials BAM countries (Brazil, Argentina and Mexico) comprise the majority of activity (about 2600 trials combined).
Therapeutic areas (major) in LA include CNS, ID, Oncology, CV .
The LA regulatory process averages between 4 to 8 months.
FDA inspections are on par with other parts of the world with respect to compliance issues.
Sponsor Considerations – 2015, India is expecting a significant increase in patient population across most therapeutic areas. India has lower drop put rates and failures in screening of study subjects.
There is huge growth in good health care infrastructure Tier 1 cities with lesser growth in Tier II and III cities.
Cost Competitiveness – Only one of many factors to consider when placing a clinical trial. To date, India is the least expensive country to conduct clinical trials.
Clinical trial experience in India is very good. Relatively inexperienced as a country with the conduct of clinical studies but quality is very good. The share of global trials is expected to double in the coming years.
Sponsor Considerations –
Companies are establishing an Indian presence where it makes financial sense. Many companies are moving towards partnering in country. Leverage for global companies by having local presence.
Key factors – cost effective, rich genetic diversity, quick patient recruitment, English speaking Inv./Doctors, inherent advantage in IT skills & study set up, data management statistical programming.
Challenges – Only parts of clinical devlopment are outsourced, regulatory approvals takes about 90 days, The Drug Controller General of India (DCGI) is reluctant to approve FTIM studies to be done in India, there is a shortage of GCP trained investigators.
Supplier and Market Considerations- Breaking up a clinical trial into input/process/output would allow a sponsor to define a global strategy by utilizing different delivery locations for each activity which allows for flexibility in conducting. This approach also allows for flexibility in the distribution of work across different vendors.
Key points for setting up trials on a global basis – Multi-Sourcing strategy (clear strategy, cost benefits thru vendor competition, multiple vendors, scalability), get the right multi-sourcing tools (vendors performance management, service agreements, performance indicators, benchmarks, governance models, mutual beneficial agreements), promote innovation (push vendors to improve efficiency and satisfaction while driving costs down, create culture to generate new ideas.
- Lack of appropriate knowledge transfer
- Incomplete documentation
- Inaccurate volumes projections
- Infrastructure & Technology Issues
- Staffing Gaps
- Suggested Metrics for Clinical Operations Know what needs to be done when, best practice, benchmarks
Governance – Need monthly meetings to keep on top of all issues, daily/weekly status reviews and quarterly reviews are appropriate.
Project Management and Tracking tools are needed.