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| PLENARY SESSIONS |
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| Year : 2021 | Volume
: 6
| Issue : 1 | Page : 56-59 |
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Strategies for Greater Engagement of MWAN in Global Clinical Trials
Prof Ifeoma Okoye1, Ashoka Fellow2
1 MBBS, FWACS, FMCR Director, University of Nigeria Centre For Clinical Trials (UNNCECT) Professor of Radiology, College of Medicine, University of Nigeria Nsukka and University of Nigeria Teaching Hospital Enugu(UNTH)
2 Editor of West African Journal of Radiology, Consultant to NAFDAC on Clinical Trials & Co-Chair Nigerian Clinical Trials Technical Working Group, Chairperson, Association for Good Clinical Practice in Nigeria(AGCPN), Chairperson, 'Breast Without Spot' Initiative, Co-Director, Bone Marrow Registry, Nigeria, Past Observer to The Board of Union for International Cancer Control (UICC) CaPTC Pi, Member, National Health Research Committee of the National Health Act Member National Cancer Control Steering/Implementation Committee Board Member, Pink Oak Cancer Trust
| Date of Web Publication | 30-Jun-2021 |
Correspondence Address:
 Source of Support: None, Conflict of Interest: None
How to cite this article:
Okoye PI, Fellow A. Strategies for Greater Engagement of MWAN in Global Clinical Trials. J Med Womens Assoc Niger 2021;6:56-9 |
How to cite this URL:
Okoye PI, Fellow A. Strategies for Greater Engagement of MWAN in Global Clinical Trials. J Med Womens Assoc Niger [serial online] 2021 [cited 2023 Sep 26];6:56-9. Available from: http://www.jmwan.org/text.asp?2021/6/1/56/319869 |
| Introduction | |  |
Clinical Trials is the next frontier for growth and revolution in Africa.
A strategic model for the future of clinical trial sites in Africa: A gateway to developing quality management systems.
The Association for Good Clinical Practice has been driving capacity for clinical trials in Nigeria since 2006.
AGCPN Launched Out a Pan-African Network of Multidisciplinary Network of Clinical Researchers to Accelerate Clinical Trial Capacity in Africa.
In 2017, This Network, transformed to the “African Clinical Trial Consortium”. ACTC recognizes clinical trial opportunity as next frontier for growth and revolution in Africa.
| Globalization in Clinical Trials | | |
”The landscape Globalization is changing and clinical trials starting now are becoming more and more global with increased activities in the new emerging economies.” - Getz, K.A., Applied Clinical Trials, December 1, 2005
”A truly global company will be one that uses the intellect and resources of every corner of the world.” - John F. Welch, General Electric
”Globalization has shrunk the world and enlarged the R&D process to multinational dimensions” - Dr Margaret Hamburg, FDA Commissioner.
| The Concept of the Africa Clinical Trial Concept (ACTC) | | |
The theme of the 2nd All Africa Clinical Trial Summit, which was held August 16-18, 2019, was “A strategic model for the future of clinical trial sites in Africa: A gateway to developing quality management systems”.
The intention of the 2019 conference was to propose a system for the development, training, establishment, sustained mentorship/oversight of 'accredited' Clinical Trial Units (CTUs) in each of the African countries. This will build confidence in industry and funding agents, which is critical to the growth of Clinical trials in Africa. CTUs were established in High Income Countries (HIC), to standardize practice according to GCP. All trials are now required to be supported by a CTU IN HICs. This was not an easy transition but it instilled confidence in industry and funding agents alike.
Thus it is a good Strategy for CTUs to be established in African countries to achieve efficiency, harmonization & International standardization, which will instill confidence quickly, efficiently, with minimal cost and sustainability of clinical trials in Africa, for the future.
Essentially the plans of The AFRICAN CLINICAL TRIAL CONSORTIUM {ACTC}, is *to enhance the integration of Africa into the global Clinical Trial Enterprise and contribute to the transformation of African economies through Clinical Trials, as well as help Africa set its health-Care Priorities, through an intentional effort to abolish the data dearth in Africa (in line with the African Union's Agenda)
ACTC Challenges In Africa (GAPS IN AFRICA)
- The disproportionate nature of Africa's triple 'huge disease burden' in comparison to the rest of the world & disparities in subtypes & presentation characteristics.
- Poor clinical trial volume which is as a result of the inability to set health care priorities.
- Poor representation in genome-Wide Studies & Precision Medicine
All these leaves Africa holding the 'wrong end of stick' in global healthcare equation.
Benefits of Clinical Trials to a Country Using India as a case study:
Clinical Trial Improved India's Economy: The Indian pharmaceutical industry is growing at an annual rate of 11% while the clinical research industry is growing at an annual rate of whooping 84%.
Mckinsey estimated that clinical research in the coutry would be a $1bn ($100m) industry by 2010 whereas Ernest and Young indicates around $1.5- $2billion by 2010.
Market value for clinical trials outsourced to India is estimated around $300million having increased by 65% in 2006. It is expected to touch $1.5-2billion by 2010. By 2010, the industry will spend USD 300M+ in India on clinical trials. India's clinical trial industry, leap-frogged and continues to do.
With India's story, we believe that clinical trial portends economic empowerment for Africa. And also, ACTC effots across Africa, will leap-frog the clinical trial industry in Africa as well.
China Pharma Market leap-frogged to number 2 in the world from the 11th position in 21 years.
ACTC's Vision
For me, this *Panafrican ACTC effort* reminds me and can be likened as synonymous with the effort that has been put together as : *Pan-African Private Sector Trade and Investment Committee* (PAFTRAC), set up, last year, to serve as an advocacy platform to support; *the implementation of the African Continental Free Trade Area* (AfCFTA). PAFTRAC was put together by by some of Africa's leading private sector institutions and corporates organisations, including; Africa's Export-Import Bank (Afreximbank) and the African Union Commission (AUC)
PAFTRAC is essentially set up to enhance African private sector participation and galvanise the views of the African private sector, mainstreaming them into trade and investment policy making.
PAFTRAC is also to serve to enhance African private sector participation in trade and investment policy formulation, including trade negotiations.
Other similar platforms, include; AORTIC, H3 AFRICA, ICE-NCD MODEL, ETC (fostering Ruwandan President'.
ACTC, is a Model like Pan-African Private Sector Trade and Investment Committee* (PAFTRAC), and has informed the introduction to this August Gathering of Distinguished Medical Women under the umbrella of MWAN, to Co-create with ACTC, to form part of the strong Hubs, that will comprise the Spokes, in this wheel of progress.
For MWAN, to be partakers of the ACTC opportunity & brainstorm to come up with strategic frameworks to disrupt prevailing negative paradigms and revolutionize the CT sector in Africa with a MWAN-Centric strategic plan & Business Model that can take us to the peaks of performance in the Enterprise, Our Incoming President, Dr Minnie Oseji has dreamt of for many years.
ACTC: AGCPN: CRC-UCT:CaPTC
Support promised to African Sites.
- Capacity/Skills Building Trainings on:
- Clinical Trial Processes
- GCP
- HREC Training & Creation of HRECs
- HSP - Human Subject Protection
- Systematic Review
- Creating Disease Protocols & Registries
- Data Management )Storage in Retrievable formats)
- Grant Writing
- Regular On-Line Webinars
- Mentorship to Create CTUs that are GCP compliant
- Oversight of CTUs & Quality Assurance
- Mentorship to have GLP Laboratories
- Recommendation to Partners t& Industry o site Trials
For clinical trials in Africa to be successful, there has to be a E-Health registration. With the eRegistration software;
- Healthcare data are the wheels of healthcare delivery around the world.
- ACTC will offer the deployment of an eRegistry Software.
- This will empower CT sites & Your Clinics, with accurate data on their activities
- Leveraging ACTC eRegistry's messaging center, can be used by CT sites & Your Clinics, improve on Participant/Patient Recrutment, Retention, Compliance, follow-up and Monitoring
- This includes reminders on tests, appointments, awareness of possible adverse events, renewal on investigations, public health education etc.
| ACTC Clinical Trial African Thrust Set to: | | |
- Ensure stringently regulated ethical Conduct Of human research in Africa.
- Increase Africa's Clinical Trial Attractiveness Index FROM CURRENT
- 4.56/10 & Boost Vol of CT in Africa
- Power Africa's Healthcare Infrastructure
- Drive 'Improved Standard of Care'
- Innovate Local Vaccine/Medical devices/Indigenous drug
- Development
- Build Local Capacity/Expertise for Natural Product Development
- Diversify/Energize African Economy
Benefits
- Investigator Initiated Trials: this is best with PharmaPhase IV research to compare a company product with a competitor.
- Suggest to Pharmaceutical that their product is coming into new populations or that there are unique disparities in seizure types, peculiar to your patient population, you have noted in your practice that were not tested in the initial trials.
- Scaling up participation in Global Trials through collaborations/partnerships.
- ACTC: Will provide support to find Partners, Connect you and work with you to leverage the collaboration/partnerships, Build your Capacity through our over 13 year old trainings.
- ACTC Grant Office: to assist you with information on grant Calls Put Partners Together To Write & Submit The Grant. Work with Partners 'BLUE CIRCLE LITE' to offer Researchers solutions that will easily have their data in retrievable forms.
- UNNCECT: A Template Project brought into existence by AGCPN-ACTC Advocacy. ACTC Already Mobilized/leveraged their Partners To Mentor UNNCECT into Excellence.
- ACTC Assisting with the strategic frameworks, Creating A Business Model, Sourcing Faculty for the Proposed Masters/PGD programmes that will foster CT Infrastructure , and Sourcing Equipment.
Recommendations Emanating From The Summit On Way Forward For Setting Up 'A Clinical Trial Unit'
Clinical Trial Units are specialized Biomedical Research Units which; design; centrally coordinate and analyse; clinical trials and other studies:
Key Personnel Needed For A Clinical Trial Site:
- Physician
- Director
- (The Principal Investigator… Head of the Team)
- Co-Pi/Co-Investigators
- (Any HealthCare Provider or Biomedical Scientists)
- Other special field, such as; Pathologist, Radiologist, Radiation Oncologist … Multidisciplinary Team
- CTU manager
- A Trained Research Nurse in the CT process
- Pharmacist
- CT coordinator
- Other Research Nurse
- Lab technician
- Data capturers
- Consenters
- Phlebotomist
- Field workers
- ERB (Ethical Review Board)… IHREC
Infrastructure
- Building/ Shared model
- Waiting Area
- Consenting Rooms
- Consulting Rooms
- Diagnostic
- Phlebotomy
- Admin office
- Pharmacy office
- Admission wards (Paeds/adults male/female)
- IP storage (Investigational Product, IND, Medical Device)
- Site CTCP Lab
- Wash rooms, showers
- Archive room
- Gated fenced
- Courier international/local
- Lab equipment to GCLP.
Barriers to Setting Up A CT;
- Funding
- Burden of expectation (PI)
- Paucity of Disease Registries and Data in Retrievable Forms (Lacking data on
- therapeutic areas
- Unclear regulatory ethics requirement (Lack of harmonized requirements, Unclear Regulatory Timelines)
- PI Team
- Inadequately trained research site / staff in 'Scientific Conduct…. Time (training, conduct etc)
- Poor leadership structure
- Unclear job descriptions
- Poor Patient Retention Strategies
- Corruption (absent ethical leadership + Lack of transparency in financial management)
- Unrealistic expectations of financial Rewards that can be gained (unless Industry Sponsored)
- Poor appreciation, of need for; Continuous learning, staff development (Each Specific Protocol, requires, its own training to avoid protocol deviation
- Lack of structure & expertise, to obtain & absorb Clinical Research (CR) funding through grants.
- Lack of Mentorship
- Poor Value for science, genuine dedication of the researcher to all the tedious processes required to ensure compliance to GCP.
- Poor Data management-Documentation (Adherence to Good Documentary Practice
- Poor Infrastructure-internet, roads, electricity, water supply archives (long term), IMP storage, transport, labs
- Poor Political Will & Institutional support
- Volatile finances - exchange rates … Trust & Comprehensive Budgeting Issues
- Inadequate Data security, Archiving
- Community resistance (guinea pig mentality)
- Patience needed to Build Trustworthiness
| Clinical Trial is Next Frontier for Growth for Africa … Why? | | |
The conduct of clinical trials is 'high on the list' of enterprises which can leapfrog Africa into the recommendation of ranking bodies like Bloomberg; “adopt New Technologies & develop capacity to nurture innovation as the only strategy to move Africa up the development ladder”
We are convinced time has come for Africa to take ownership of her health economy. The days of Foreign-led and foreign executed solutions that fails to build and retain capacity in Africa is over. Thus the continued low volume of clinical trials in Africa is counterproductive to the vision for a healthy Africa.
A PARTNERSHIP WITH ACTC CAN BE THE VEHICLE TO SET THE STAGE TO INCREASE THE ATTRACTIVENESS OF THE CONTINENT TO GLOBAL CT SPONSORS
| Conclusion | | |
Africa apart from trying to contend with several financial constraints is also an unfortunate beneficiary of a 'Triple Burden of Disease'… THIS HUGE DISEASE BURDEN COULD BECOME AN ASSEST TO AFRICA AS IT ADDS TO AFRICA'S ATTRACTIVENESS, DUE TO POTENTIAL FOR FAST RECRUITMENT OF SUBJECTS.
Clinical Trial, 1.5 Trillion Dollar Industry, could become the Gold of The African continent if properly nurtured & regulated/stringently monitored, & power the healthcare infrastructure, impact capacity building/skills acquisition, create jobs, & improve the economy. INDIA, China, Latin America, are test cases.
ACTC intends its Clinical Trial Pan-African Thrust to Be: A vehicle for Africa to effect a 'paradigm shift' from being consumers to being producers-a chance for Africa's Indigenous Drug Development to gain Global relevance.
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