OSCT Vienna Press Release 11-12 April 2018

April 11, 2018 9:00
African Patients Matter! New African Research Non – Profit to Enhance, Accelerate and Sustain Clinical Trials in Nigeria
 A non -profit organisation will be set up focused on advancing clinical trials in Nigeria following discussions held during the Operation Strategy for Clinical Trials in Nigeria Event 2018

During April 11–12 2018, expert research delegates from Nigeria, South Africa, United Kingdom and United States of America gathered in Vienna, Austria for the inaugural Operational Strategy for Clinical Trials in Nigeria.

The core objectives of the event were to bring key global stakeholders together to engage in knowledge sharing, exchange of ideas and benchmark on how to operationalize clinical trials in Nigeria. Additionally, such learnings focused on the emerging markets’ operational models, innovative methods of maximizing value in the clinical trials industry using digital technology and regulatory obligations.

The core objectives of the event were to bring key global stakeholders together to engage in knowledge sharing, exchange of ideas and benchmark on how to operationalize clinical trials in Nigeria. Additionally, such learnings focused on the emerging markets’ operational models, innovative methods of maximizing value in the clinical trials industry using digital technology and regulatory obligations.
During the summit

During the summit Professor Folakemi Odedina (University of Florida) highlighted the underrepresentation of Blacks in global clinical research, stating that 17% of the world’s population (over one billion) are Black, but less than 3% of the Genome-Wide Association Studies participants were reported as Black. Prof. Odedina further shared that clinical trials in Africa can be very successful. For example, the CaPTC study in prostate cancer successfully recruited a familial cohort of over 500 participants within 3 months in Nigeria, Cameroon and the US.

From the Industry perspective, Shalom Nnadi, Transformational Leader from Roche delivered a riveting presentation sharing the annual Roche leadership experience in the Tanzania to support cervical cancer screening. The handpicked region in Tanzania she visited with other Senior Leaders from Roche was called Njia which had a high rate of cervical cancer. The team worked with local communities and the government to assess challenges and provide tailored sustainable logistical solutions such as creating a screening centre which included a training and awareness campaign (with a train the trainer approach). This resulted in 838 women screened with 21 treated since 2017.

Nancy Meyerson-Hees, Clinical Quality Consultant and Associate Partner at Admedicum highlighted that for global trials time, complexity, costs and endpoints are the key challenges. She shared some of the Tufts University research on enrolment timelines and increasing protocol complexities. Her work as part of European and Developing Countries Clinical Trials Partnership (EDCPT) as an enabled her to review up to 200 requests for funding. The key message from her presentation was to plan early and focus on globalization and for emerging regions like Nigeria to build on their clinical trials standards, support systems, risk assessments and quality processes and be inspection ready (Federal Drug Agency or FDA now requiring inspections for 1.9% domestic sites and 0.7% from foreign sites). For the Nigerian context, Professor Ifeoma Okoye, Consultant Radiologist, Chair of the ‘Nigerian Clinical Trials Technical Working Group’, Inaugurated by the National Agency for Food and Drug Administration and Control (NAFDAC)/ Consultant to NAFDAC on Clinical Trials and Chair of the Non-profit Association for Good Clinical Practice in Nigeria (AGCPN). She emphasized that due to lack of funding and assistance with developing Protocols and SOP for Clinical Trials on these Natural products, the products leave the African shores and return as Medicines developed outside Africa. This constitutes a grave loss of innovation and resources for Africa, denying African patients of opportunities to use drugs developed within the region at affordable costs. Thus, assistance for Investigator Initiated Clinical Trials and sourcing ‘Angel investors’ are needed for natural food products development as Medicinal Products (through Clinical Trials to the Market place.!

The Chair of the Summit, Adama Ibrahim EMBA put forward a new operational strategy for clinical trials in Nigeria and suggested to focus on pragmatic real-world trials to generate valuable data and insights with less infrastructure and costs. This type of trial could offer advantages in a country like Nigeria with high drug naïve populations, modest GDP growth and an emerging interest in improved healthcare in general.

Dr Ado Muhammed, Consultant for Pharmedas Research brought in the local Nigerian CRO perspective and shared the benefits of forming local alliances for the purposes of increasing efficiency and to bring down costs. He also talked about Katsina, a state in Nigeria which has the highest concentration of sickle cell patients in the world but are not participating in any global industry led clinical trials. Dr Muhammed summarized that Nigeria offers an attractive clean canvas where working with a local CRO would enable the successful implementation of trials.

The topics discussed moved onto Patient Recruitments by Rasmus Hogreffe, Director at Patiro who shared that the business model in clinical trials is broken due to high R&D investments that are made for unguaranteed returns. He stated that the solutions lie in starting to share risk and working with the model in Denmark where patient enrolment is not meeting forecasts. His key message is to get to know the patients and tailor the best media to them, to keep the face to face contact where possible and rely on different approaches.

Technology advancements were covered by Mehdi Benchoufi, Chef de Clinique, shared an innovation he created with a consortium in France that provides and an open source app as an ultrasound machine delivered through a mobile phone camera. This invention is low cost at $500 compared to the remote ultrasound on the marker at $10,000. Ultrasound images can be captured for making non-invasive diagnosis and address the issues faced in SSA for lack of imaging or 70% of all imaging machines not used in Africa. The plan is to conduct trials in Morocco and Ghana and use artificial intelligence built into the imaging to deliver automatic diagnosis. This is planned to be production by July 2019.

Abubakar Umar, Co-Founder of Cryotrust provided an overview of the Blockchain technology as a distributed ledger system with some interesting unique properties. He has developed an energy token in the energy sector in Nigeria as a utility using a public Ethereum based protocol. He showed a cartoon on how transactions take place using this technology at the local level and transferred successfully internationally. This company is moving forward with their initial coin offering this year. There are parallels shared on how the clinical trials industry could use Blockchain in Nigeria in areas such as Patient Data such as Biobanks, Digital ID and Healthcare Accreditations.

A breakout session enabled brainstorming how initiatives can be best delivered through a non-profit organization to enable operations in a non-biased way with all core stakeholders including regulators. The emphasis being to increase access to medicines and understand what makes sites fit for purpose and audit ready. The Chair, Adama Ibrahim, EMBA highlighted that the new Non-profit organization will be best placed as the “trusted professional bridge between pharmaceutical industry, regulators, healthcare professionals and patients in Africa.”

Although the new non-profit organization is still in its infancy, the official launch is scheduled for October 2018 and the next Summit in Nigeria has been planned for early 2019. The operating model will include regulator engagement and support with developing quality processes and practises, for the industry partners to support with creating an Africa strategy development to design market opportunities, investment return and clinical trials landscape, tactical operations to include robust disease, sites and patient level feasibility, execution oversight of local CROs and stimulating local research opportunities. For sites there will be capacity building to elevate centers of excellence and finally for patients an educational campaign on research.

For more information about the Operation Strategy for Clinical Trials in Nigeria Event and to watch the video, please contact: info@emqt.org.uk