The UCRC Executive Committee met for the second time on Friday, August 16, 2019, in the UCRC lab meeting room. This high-level meeting chaired by the UCRC Director, Prof. Seydou Doumbia, gathered about ten participants from the Ministry of Health and Social Affairs, the Minister of Higher Education and Scientific Research, the University of Sciences, Techniques and Technologies of Bamako, the Faculty of Medicine and Dentistry, the Malaria Research and Training Center and the National Institute of Allergy and Infectious Diseases, etc.
The agenda was about: Overview on Goal and Structures, recommendation from previous meeting, update Ongoing Research/projects, capacity building (Training, Infrastructure), collaborations/perspectives, capabilities within UCRC center and laboratory Achievements, and challenges. After his words of welcome, Professor Doumbia recalled the objectives and strategies of the UCRC. These include: Develop and maintain the UCRC as a sustainable entity capable of conducting excellent clinical research, facilitate the training and development of the next generation of clinical research scientists and professionals, and generate knowledge, disseminate research results and promote the utilization of findings.
Concerning the organizational aspect of the structure which has not changed, Prof. Doumbia recalled that the UCRC family “is growing with 176 employees today!” (61 on PREVAC-Warm based, 56 on IVCC); calls for applications are also open for Biostatician and Social Mobilization Officer. In terms of actions, he ensured that “the laboratory is well organized and things are going well”, it is the same for the administration where current positions, such as the position of the HR / Logistic Manager, communication officer…, are now working.
In his presentation, Professor Doumbia mentioned several activities that have been carried out. As part of the PREVAC ( Partnership for Research on Ebola Vaccination) project, whose study objective is : to compare 3 vaccine strategies each with placebo for safety and immunogenicity in adults and children in three countries in West Africa (Guinée, Liberia, Sierra Leone, and Mali), he said “as of the end of July 2019, 40 participants have completed, their Month 12th visit have started till December2019, planning for the PREVAC UP subject follow-up schedule to keep participants engaged, FANG testing at UCRC ready to start when the PREVAC lab working group gives their approval.”.
Concerning the attractive targeted sugar bait phase III tria project, the baseline study 2019-2020 followed by Randomization of 60 clusters into Intervention and Control. In this project, the UCRC assures the Role of Sponsor (Scientific, Regulatory and Proper Monitoring). For the site visit for QC and Financial Audit (April 2019), SOPs, Laboratory capacity, and data management and QC capacity well appreciated. However, the SOPs for SOPs are needed, the appropriate Monitoring System and archiving system have to be set-up; and the USTTB has to develop an appropriate safeguarding policy and adequate supporting monitoring and reporting mechanisms, etc. For NOVARTIS/QuintilesKAE609 study, the outcomes are as followed: Number of monitor’s visits 12, Number of screen failure 12 and number of Randomized participants 4. AS challenges: Recruitment / referral, Lab, staffing; Reimbursement patient cost; Laboratory Cost-sharing.
On the D2EFT (dolutegravir and darunavir evaluation in adults failing therapy) side, a phase IIIB/IV randomized open-label trial to compare dolutegravir + pharmacoenhanced darunavir versus recommended standard of care antiretroviral regimens in patients with HIV infection who have failed recommended first line therapy:(FDC) of nevirapine, stavudine and lamivudine. Let’s remember that, Mali UCRC has been identified as a site to participate in this 3 year trial sponsored by University of New South Wales, The Kirby Institute.
As for laboratory, Prof. Doumbia noted that capacities are developed. « At the LABORATORY-IMMUNOCORE level, New Core Lab Management software has been implemented and includes: Inventory systems with Malians leading effort, dedicated repository section”, he added. UCRC CLINIC FACILITY side, the clinicians have completed around 600 planned visit and around 180 unplanned visits with PREVAC Study, 45 visit with Novartis study, Zero Serious Adverse events, Drug Management (UCRC-CVD) for PREVAC Study, Temperature monitoring, Vaccine and Pills randomization, Direct Involvement in studies (PREVAC, NOVARTIS KAE, DE2FT). In terms of Community engagement, we note 20-member community field team hired to support the PREVAC study and any additional study need, etc. In the field of communication, The UCRC Director recall that the website and the social networks are working for the visibility of the center.
As Outreach activities, the center received this year, Ian Lipkin, Columbia University, and Lisa Hensey, from NIAID ( a working visit); His Excellency Mr. Dennis Hankins, US Ambassador to Mali; the Minister of Higher Education and Scientific Research, Professor Mahamadou Famanta (The visit to the UCRC labs), the Vice Dean at NIH (during AS of Dermatologymeeting). In addition, it organized the scientific writing workshop (researchers and Faculty members), etc.
As Planned activities, the UCRC has a strong ambition. As part of the Sustainable entity for excellent clinical research, it wants to train 2 internal monitors – Ongoing, implement 3 research protocols (EID, IVCC Trials, Ebola Trials), etc. For preparing the next generation of clinical research scientists, the center plans to bring a Continued support to training-Short term and degree training, to organize a West Africa regional consortium-November 2019 and the Clinical trials and Grants writing workshop-Decemberr2019. In terms of disseminate and promote the utilization of research findings, website-maintenance and update, Newsletter and brochure, Symposiumat ASTMH are planned.
Challenges at the center
Nowadays, the center faces huge challenges, including a space problem and a lack of vehicles (For 175 staff member with 130 people working in office; At the laboratory: 5 offices shared by 14 people; At the Clinic: We have 4 offices shared by 15 people The remaining staff are working in conference rooms, labs, and or other offices on the campus). To overcome these difficulties, it is planned to build: the lobby + 1 floor and storage project with estimated budget of 180 millions CFA. Finally, many recommendations have been made, by which we can note the capitalization of the Community engagement position, which remains a boon for the achievement of research objectives