Dengue: A disease burden in Sri Lanka A Complex Phase III Vaccine Trial

Transcription

1 Dengue: A disease burden in Sri Lanka A Complex Phase III Vaccine Trial

2 Country Overview Size: 65,610 sq km Population: 21,324,791 Population growth rate: 0.904% Population: Not genetically homogeneous and stable in terms of internal migration Life Expectancy: Male 75 Female 77 Literacy rate: 92.38% (M: 94.5%, F: 90.6%) Business Language: English Per Capita Income: USD 2053 Per Capita GDP (PPP): USD 4,500 Growth Rate: 6.4% Inflation Rate: 2.4% Form of government: Executive Presidency / Parliament Administrative Units: Nine provinces

3 Dengue burden in Sri Lanka First dengue patient was reported in Since year 2000, dengue has become endemic in the country In 2015, 4828 cases of DF/DHF were reported from all districts (Table 10) while 6 deaths were reported (CFR 0.2%). From , a drastic increase in dengue cases, with an average of 35,000 cases per year and an incidence of 175/100,000 population reported nationally. In 2017, 7742 suspected dengue cases have been reported to the Epidemiology Unit. Approximately 43.47% of dengue cases were reported from the Western province. According to the clinical findings majority of the reported cases were: Dengue fever (92.9%) Dengue fever without shock (6.9 %) Dengue fever with shock (0.2%) Range < Percentage of reported cases Age distribution of reported cases

4 Disease burden Globally The actual numbers of dengue cases are underreported and many cases are misclassified It is estimated globally, 390 million dengue infections per year of which 96 million manifest clinically (with any severity of disease). The number of dengue cases reported annually to WHO has increased from 0.4 to 1.3 million in the decade , reaching 2.2 million in 2010 and 3.2 million in 2015

5 Disease burden Globally Dengue is mainly found in tropical and sub-tropical climate world wide

6 Disease burden Globally

7 Dengue: Epidemic crisis in Sri Lanka? In the year 2017, the Epidemiology Unit of the Ministry of Health (MoH) Sri Lanka reported dengue fever cases, including 215 deaths Approximately 43% of the dengue fever cases were reported from the Western Province Preliminary laboratory results have identified Dengue virus serotype 2 (DENV- 2) as the circulating strain in this outbreak. DENV-2 has been infrequently detected since Statistical analysis of dengue in Sri Lankan districts for 2017 Kalutara Ratnapura Kandy Gampaha Colombo district

8 Dengue: Epidemic crisis in Sri Lanka? Number of dengue cases in Sri Lanka for Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Statistical analysis of dengue in Sri Lanka

9 Dengue: Epidemic crisis in Sri Lanka?

10 Statistics Incidence, Year 2013

11 Statistics High and low risk areas, Year 2013

12 Statistics Distribution of DF/DHF cases in Sri Lanka from Epidemiology Unit, Ministry of Healthcare and Nutrition

13 National Guidelines on Management of Dengue Fever & Dengue Haemorrhagic Fever Adults Children and Adolescents

14

15 RemediumOne Successful managing a multicenter study in Sri Lanka Experienced investigators Efficient and clearly defined regulatory review process Experienced coordinators Experienced allied health staff High rate of protocol compliance Robust project delivery system and quality assurance Compliance and Quality Assurance

16 RemediumOne: Delivery System Project Management Recruitment & Retention Performance Management Data Management Administration Safety & Compliance

17 Our Hands-On Clinical trial experience different therapeutic area RemediumOne: Growth underpinned by robust quality and safety focus Clinical trials hands-on experience Completed and On Going Trials Vaccine trial Respiratory trial Nephrology trial Pediatric trial Opthalmology trial Autoimmune trial Cardiovascular trial Oncology trial Diabetes trial Rheumatology trial Gastroenterology trial Years

18 Dengue Vaccine Trial

19 RemediumOne: Avenue to dengue vaccine in Sri Lanka Information Number of trails 01 Status Supported by Recruitment target 2000 Outcomes Completed Recruitment completion Apr 2017 Experienced staff Epidemiology Unit, Ministry of Health Investigator sites: 04 tertiary centers under 04 PIs Co-Investigator (Specialist Pediatrician): 10 Sub-Investigator (medical officers): 27 Study nurses: 15 Site Coordinators: 40

20 Study Status Information Outcomes Number of studies 01 Screened 2400 Randomised 2100 Recruitment target 100% Retention rate 100% * Sri Lanka ranked second, globally, in completing the country target in this multinational study.

21 RemediumOne: Avenue to dengue vaccine in Sri Lanka International, multicenter phase III dengue vaccine trial - Sri Lanka only South Asian country to participate Investigational medicinal product for US-FDA submission Healthy children between 4-16 years of age to be recruited Work with multiple stakeholders including government agencies including schools Short recruitment period and five-year follow-up Protocol administration of two doses at 0 and 3 months Liaison with local & overseas vendors Execution of multiple agreements

22 RemediumOne: Avenue to dengue vaccine in Sri Lanka 2100 healthy children to be recruited from 04 investigator sites in 06 months Completion of administration of second dose 0 Year 1 Year 2 Year 3 Year 4 Year 5 ERC and RA approvals Active surveillance weekly contacts with every subject s parent for five years follow up 2100 surveillance contacts/ week/ five years. A home visit should be arranged if a subject s parent is not contactable for more than two consecutive weeks

23 RemediumOne: Avenue to UC trial in Sri Lanka P R O J E C T S T A K E H O L D E R M A N A G E M E N T P R O J E C T P R O C U R E M E N T M A N A G E M E N T Vaccination centers Execution of project specific agreements between The sponsor The Sponsor Local project coordinator ( CTU & RemediumOne ) CRO CRO Local Project Coordinator (CTU and RemediumOne) State institutes Regulator Local and internation al vendors State tertiary care hospitals Ministry of Health, Epidemiology unit Tertiary care hospitals (Sites) Investigators Local vendors

24 RemediumOne: Project specific quality management CTU - RemediumOne ISO 9001:2015 certified clinical trial services Support investigator sites Preparation of institutional IOPs Preparation for regulatory audits Preparation for GCP audits Conduct internal quality audits Regular staff training on quality management

25 RemediumOne: Achievments 100% recruitment Excellent retention to date Administration of 2nd dose to more than 98% at three months within the stipulated timeline 100% weekly contact for febrile surveillance - highest number of reports of febrile episodes Liaising with multiple State institutions from study inception including primary health care network One participating site recognized as best among all participating sites Many successful sponsor & CRO audits

26 Study Status VISION (Our aspiration) To become the most valued partner to our Clinical Development and Life Sciences clients and a role model to our industry. VALUES (what we believe) CLIENT FOCUS ACCOUNTABLE RESPECT ENDURE Responsible, responsive attitude to our clients Ownership, honesty and integrity Honest, transparent, fair in our actions and communication Perseverance and belief in enduring partnerships inquiries@remediumone.com

27 PARTNER FOR LIFE THANK YOU