How clinical trials help improve the quality of patients’ lives, despite many obstacles
Long distances and arduous journeys, impending outbreaks of violence that threaten life and limb, recurring power failures and disrupted telephone connections – anyone who has conducted research into new drugs and treatment methods in emerging and developing countries will often have had to face adverse conditions. However, it is in these countries in particular that carrying out clinical studies is of utmost importance in order to improve public health.
Launched with the support of the Federal Ministry of Education and Research (BMBF), the aim of the TAKeOFF research network is clearly described in its name – tackling the obstacles to fight filariasis and podoconiosis. Infection researchers from Ghana, Tanzania, Cameroon and Germany have come together under the umbrella of this network. They are all looking for ways to comprehensively combat lymphatic filariasis and other forms of lymphoedema which threaten more than 850 million people worldwide.
A single mosquito bite or walking barefoot across volcanic soil – unlike at our latitudes, in the humid, tropical regions of the world, it takes very little to contract a serious inflammatory disease. The shocking images of lymphatic filariasis – also known as elephantiasis – have made this disease very well known. Patients display grotesque swellings, particularly in the feet and legs, which often make it impossible for them to continue working. They suffer from fever attacks and intense pain and are often excluded and isolated from their villages and even from their families. Supported by German cooperation partners, Samuel Wanji, an internationally experienced infectious diseases specialist and professor at the University of Buea in Cameroon, is working on a clinical trial that will provide help for these people.
Making things run smoothly – staff on the ground perform invaluable services
Even in Germany, it is not always easy to find people who are willing to take part in a clinical trial and in Cameroon, in central Africa, the researchers also faced a critical hurdle right from the start. They needed to find enthusiastic team members who would have to travel to hard-to-reach rural communities in the Bafut region to educate the inhabitants about the disease and familiarize them with special sanitary measures to help them avoid contracting the disease or alleviate its symptoms. These community health workers are also tasked with breaking down prejudices and examining patients on-site to determine who might fulfil the criteria for participating in the trial.
The project supervisors in Samuel Wanji’s team not only struggled to overcome prejudices in their daily work, but many other obstacles as well. Independent since the early 1960s, Cameroon has long been considered an anchor of stability in the region, but even here there is a growing risk of violent confrontations erupting between government authorities and opposition groups.
“We only had two options,” explains the 59-year-old infectious diseases researcher, “we could either give up the trial due to the prevailing conditions or be all the more committed to helping our patients.”
Combating neglected diseases is a matter very close to the heart of the native Cameroonian who was trained as a researcher at the University of Montpellier and the Natural History Museum in Paris. He is a committed researcher and teacher on the topic and works to implement relevant health programmes.
Research – and aid – despite difficult circumstances
It is often a difficult undertaking to reach out to patients in the rural regions of Cameroon and get them on board. Due to the uncertain political situation, the TAKeOFF investigation teams were unable to travel to the respective village communities as originally planned, but instead asked study participants to come to premises that had been rented specially for the purpose. This calls for a high level of personal commitment, particularly from those suffering from lymphoedema, which produces massive swellings in the arms or legs. Patients have to travel far from their homes in tropical weather, sometimes with open wounds and often at great risk, to come to the study centres where a medical team carries out further examinations and interviews and takes blood and urine samples, which are filed in the patient’s records.
On top of this, researchers repeatedly report having to deal with recurrent power failures, defective refrigerators that are needed for storing patient samples and insufficient supplies of nitrogen, which is used to freeze patient samples. Another problem is the poor quality of the telephone and internet connections, which makes communication with the German TAKeOFF cooperation partners more difficult. However, the project partners in Cameroon, as well as in Ghana and Tanzania where similar studies have also been launched, are reliant on receiving quick answers from their German colleagues, particularly with regard to accepting new participants for the trial and the digital transfer of their samples and patient data, which are all double-checked in Germany.
“The basic conditions are often so difficult that we need to communicate using private mobile phones to help our patients on-site as quickly as possible,” says Wanji, describing the conditions his staff face every day.
Close contact with German cooperation partners
“I have the utmost respect for the work done by our partners in Cameroon, who are conducting a clinical trial in accordance with international quality standards for good clinical practice in spite of major external difficulties. But this is the only way for us to obtain robust scientific answers as to whether our new treatment will benefit these patients,” explains Bonn-based microbiologist Professor Achim Hörauf.
He is the German co-coordinator of TAKeOFF and Director of the Institute of Medical Microbiology, Immunology and Parasitology at the University Hospital Bonn. In cooperation with the working group headed by Dr Ute Klarmann-Schulz, his responsibilities in this project include setting up a biobank and database for storing the patient data, blood, urine and saliva samples from the clinical trials. The data is gathered and entered on-site in Africa before being processed and analysed together with the team in Bonn. Half of the samples are kept on-site, while the other half are sent to Bonn. The research team in Bonn is in contact with their African colleagues nearly every day to assess data and photos which have been sent from the regional health centres – telemedicine in practice. But only communicating by phone or computer is not enough – the German scientists regularly travel to Africa to discuss the next steps of the project. The German partners are clearly impressed:
“The dedication shown by the local assistants for their patients is truly admirable. To even get a clinical trial up and running under these difficult circumstances is a tremendous achievement.”
Research Networks for Health Innovations in Sub-Saharan Africa
The BMBF has been funding five German-African Research Networks for Health Innovations in Sub-Saharan Africa since autumn 2017. The research consortia are led by African scientists and researchers. The main aims of the networks are:
- to strengthen scientific and scholarly cooperation between German institutions and research institutions in Sub-Saharan Africa
- to establish research capacities and research infrastructures in Sub-Saharan Africa
- to speed up the process of transferring research findings into research and health agendas within the African partners countries
By supporting research, the initiative also contributes towards the development of local health systems, which in turn will ultimately help to break the vicious cycle of poverty and illness.
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