Category Archives: Uncategorized

Why African researchers prefer European funded medical research

Test_image

Esther Nakkazi
Freelance journalist, SciDev.Net

Throughout the High Level conference on the European & Developing Countries Clinical Trials Partnership-II (EDCTP2), capacity building for African researchers was a recurrent theme

It was more on increasing and elevating research done in Africa, by African researchers; building their leadership capacity to form their own teams and networks in collaboration with EDCTP.

So, I sought to find out the difference, if at all, between capacity building for African researchers from funding clinical trials by the Americans and Europeans.

Most of the African researchers I spoke to at the EDCTP2 conference in Cape Town, who receive funding from both Americans and Europeans confirmed real capacity building and networking from EDCTP funded activities.

It is, in fact, an integrated part of the EDCTP with short and long term training, building African researchers careers as well as infrastructure development. This is guaranteed and reflected in funding rules for grants and in their governance.

But they described the American funded clinical trials in Africa as Federal Express Research- shipping out human samples and not caring to build capacity among African researchers.

“I was one of the pioneers of EDCTP and we formed it to build capacity of African researchers, which is really happening compared to other collaborations. It is a reality in Africa,” said Professor Lynn Sodai Zijenah, the chairman, Department of Immunology, University of Zimbabwe College of Health Sciences.

“I am conducting three clinical trials in the fields of HIV and Tuberculosis. I will be making the preliminary results to the Ministry of Health to change policy,” said Zijenah.

Under EDCTP, I am looked at as a partner not like a third world scientist who does not know anything or pretend they are not on the ground, said another researcher.

Maire Geoghegan-Quinn, the European commissioner for Research, Innovation and Science said EDCTP is a beacon of hope for many people in Africa and a unique powerful partnership. She also described it as and an excellent example of what we can be achieved between Africa and Europe when they work together.

During the first phase of EDCTP (2003-2011) more than 200 African scientists and medical doctors got professional training, research careers were built, many students graduated with Masters and PhD degrees.

At the University of Cape Town (UCT) and Groote Schuur Hospital, Prof. Keertan Dheda a senior research fellow is working on Tuberculosis diagnosis in high burden settings.

Dheda is a typical example of a fellow who got an EDCTP fellowship was trained and is now leading a research team, collaborating with other African countries and winning bigger grants.

The first African Regional Networks of Excellence for clinical trials was also launched and a true partnership between Europe and Africa developed with over 70 per cent of all EDCTP-funded activities led by African researchers.

The vision of EDCTP2 (2014-2024) is to support 50 new clinical trials- focusing on larger and more costly phase III trials, strengthen Africa’s capacities for clinical research and train 250 African researchers and doctors.

African researchers said usually the Americans say they do not have enough funds, thus the shipment of specimens, but it is equally expensive and tedious to transport them.

Americans develop protocols and then identify their partners in Africa, researchers, whose only job is to collect specimens and data and ship them.

But African researchers still continue to partner with Americans in research even without building much capacity. Why?

“The research we do with Americans is usually not our priority but we are beggars and most of us are looking at getting promotions,” said a researcher from Zambia who preferred anonymity.

Advertisements

High expectations from EDCTP-II

Test_image

Esther Nakkazi
Freelance journalist, SciDev.Net

 

Two years from now, the second European & Developing Countries Clinical Trials Partnership (EDCTP-II) programme will kick off and expectations seems high

Nkandu Luo, Minister of Local Government and Housing Authority of Zambia outlined some of the expectations at the High Level conference on the partnership in Cape Town on 5th November

Although the partnership between EDCTP and Africa scientists was described as unique, powerful and progressive with visible results in EDCTP-I, Luo said more defined, strengthened partnership were expected in EDCTP-II.

What then are some of the expectations? Much improved partnership between the private sector, African Governments and EDCTP, with more commitment for funding to the EDCTP, more clinical trials and using the available opportunities for the benefit of the programme in Africa.

However, it was suggested that it would be important for African governments to quantify in monetary terms their contributions to clinical trials heavily funded by Europe and America.

That way, African governments would not be dismissed as contributing nothing to medical research happening in their own countries.

Scientists also suggested that EDCTP required more visibility at country and continental level, because even if it has invested so much in Africa, €400 million in EDCTP-I, it is not well known. The media could be a critical partner to achieve EDCTP visibility.

To avoid backlashes, in view of the sensitivity of the clinical trials, there is need to bring on board social scientists who should participate not only in the trials but research designs and protocols in EDCTP-II.

It was also suggested that since research subjects are human beings, the communities must be brought into the planning, design of the research protocols in EDCTP-II.

EDCTP-I invested heavily in the establishment and strengthening of Research and Ethics Committees in many African countries, but African scientists said EDCTP-II needs further investment in this area locally through Ministries responsible for research. This is key to avoid abuse of research subjects.

EDCTP and African Governments should develop a robust strategy in translating research result from documents gathering dust to on shelves to healthcare delivery in the second programme.

And lastly, the budgetary allocation for EDCTP-II, which is potentially one billion Euros, may need to be target; vaccine development, innovative treatment regimes for HIV and Tuberculosis as well as prevention therapies especially those targeting women and children such Microbicides.

It should also target investment in research of infectious diseases and other conditions interacting with HIV such as cancers.

EDCTP-II: No easy walk ahead

MunyaradziMakoni

Munyaradzi Makoni
Freelance journalist


There is no easy way nor single bullet answer to coming out with efficacious world celebrated results in clinical trials

Journey, there are many roads that will lead to the same destination. These are views and comments that came out of the EDCTP meeting.

Understanding the achievements of EDCTP’s first phase will be instrumental in guiding the second phase of the programme, according to Hannah Akuffo, Chair of the EDCTP General Assembly in Sweden

“When we started we are trying to understand the bureaucracy in Europe, there were different views. We had difficulty in planning and the challenge was how to pull off this ambitious programme, but we manage it,” Akuffo reflected ont the early days.

The radical increase in funding to a target of  Euro 200million, half of which has to be a contribution of African countries that will be matched by European partners shows our desire for the project to achieve even greater things,” she went on.

“Having a lot of money to manage is a huge challenge. We will be working with new partners building up partnerships. These are new relationships that need to be built,” Akuffo added.

She told SciDev.Net that they were keen, among other things, in a focus that develops drugs and makes EDCTP phases feed into each other.

Akuffo feels greater engagement with private sector, philanthropy; the industry both small and large has to be employed to bolster the second phase of the programme.

Marja Esveld, vice-chair of the EDCTP General Assembly in the Netherlands weighed in saying renewed emphasis on public private emphasis was good for the programme.

Kenya’s Minister for Higher Education, Science and Technology, Margaret Kamar lauded EDCPT for success in building capacity and creating networks of excellence, but called for evaluation of the centers to ensure maximum returns from centres of excellence established by EDCTP.

“We may need to evaluate what centres can do best,” she said.

An official in the same ministry, Eric Mwangi, wondered if enough was being done to ensure that areas of research were effectively covered; for instance where there is high TB prevalence.

“Among pastoralists in the same quarters in Africa, TB is spread through milk. Are they being covered in trials,” he posed

According to Salim Abdool Karim, President of the South Africa’s Medical Research Council, said such centres across Africa must be used to mobilise some of the continent’s best scientists to be part of the research programmes.

Creation of drugs and new diagnostics, he said, would benefit a lot more from sharing expertise.

“We should help EDCTP to make a genuine partnership, no one way partnership could be successful in addressing the challenges we face,” Karim said.

“Further simplfy greater partnership among stakeholders,” said Elly Katabira AIDS chair for 2012 and the president of International Aids Society who hoped for improved synergies in the EDCTP2.

But Adeyinka Falusi a bioethics professor from the University of Ibadan in Nigeria felt that a large number of women were not being brought to participate in the actual research science. She wanted the EDCTP program to promote more of them.

Finland to join EDCTP

Test_image

Esther Nakkazi
Freelance journalist, SciDev.Net


Finland will be the latest the European Union (EU) State to join the European & Developing Countries Clinical Trials Partnership (EDCTP) programme that brings together participating EU Member States with sub-Saharan countries and interested third parties to fight poverty-related diseases

Jarmo Wahlfors from the Academy of Finland who attended the second EDCTP conference held in Cape Town this week said Finland would soon join the project to strengthen Global health research

Through EDCTP, European countries have a coherent and coordinated voice internationally and a common strategy in the fight against poverty-related diseases; HIV/AIDS, tuberculosis, malaria and Neglected Infectious Diseases

“We hope to sign an agreement in Helsinki to join EDCTP and although this is not our top priority we can make it fit nicely in our plans to strengthen global health, said Wahlors.

Finland, which has strong ties with the NORDIC countries, has not been participating in EDCTP because of ‘legal’ and regulatory problems, said Wahlors. But it will be part of EDCTP II.

Seventeen other countries also expressed willingness to proceed with EDCTP-II: They are Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Slovakia has also expressed strong interest in joining the EDCTP II Programme.

The second phase of EDCTP, which will run from 2014-2024, will be bigger, supporting 50 new clinical trials-larger and more costly phase III trials, strengthen Africa’s capacities for clinical research; and train 250 African researchers and doctors.

EDCTP-II will also accelerate the development of new or improved drugs, microbicides, diagnostics and vaccines, by provision of a critical mass of resources, over 1 billion, to support clinical trials.

Meanwhile, Namibia could also join EDCTP II to become active participants and not just be recipients of research according to Alfred Adriaan Van Kent, the Minister of Education in Namibia.

It is through such knowledge networks that we hope to share information and solve our problems, said Kent who was trying to understand the EDCPT project and sell it to his nation to join.

I am trying to understand how we can become partners, to get more medical practitioners on board and play an active role, said Kent at the EDCTP II conference.

How about insurance in research for clinical trials participants?

Test_image

Esther Nakkazi
Freelance journalist, SciDev.Net


How about some of the funds raised for clinical trials being used for insurance, were the thoughts of some delegates at the high-level European & Developing Countries Clinical Trials Partnership (EDCTP) II conference in Cape Town on 5 November.

Modest Mulenga, the Director, Disease Research Centre, Zambia said the ethics committees in Africa have been strengthened to conduct fairly ethical clinical trials but participants were not insured.

So far, under EDCTP-I, the first African Regional Networks of Excellence for clinical trials was launched while National Regulatory Authorities was also established and ethics review capacities in many African countries were strengthened.

The Pan-African Clinical Trials Registry (PACTR) as an African initiative funded by EDCTP, which is now officially recognised as a WHO Primary Clinical Trials Registry was also established in EDCTP I.

“We can not go on pretending, participants in clinical trials should not only be protected ethically but even against any harm because this is research-it may or may not work,” said Mulenga.

The feeling by some scientists at the EDCPT II conference was that Insurance companies should come on board to look out for and protect clinical trials participants.

However, they stressed that insurance of participants in trials should especially be done by drug companies since they do product testing.

Partners like EDCTP would never agree to use their resources for insurance assured Thomas Nyirenda of EDCTP.

If funding partners were to insure participants it would mean that most of the money raised would be probably go to compensation. For instance, with a grant of 200 million Euros, if a clinical trial caused any harm, all these funds would be spent on compensation.

“Pharmaceutical companies should insure the participants and I think in most cases it is provided for but Africans researchers overlook it,” said Nyirenda.

When nobody seemed to care much about time!

MunyaradziMakoni

Munyaradzi Makoni
Freelance journalist

 

When Peter Henlein invented the first watch in 1504 in Nuremberg, Germany, he must have known the essence of keeping time, something that went wrong during the visit to clinical trial sites in Cape Town by the delegates.

On the morning of 6 November, two buses headed for the University of Cape Town (UCT) from the Cape Town Convention Centre. Going to Groote Schuur Hospital-a hub for research-was to give delegates grounding on work being done at the central point where figures and statistics are analysed

The Groote Schuur Hospital is a large, government-funded, teaching hospital situated in suburb of Observatory. At the hospital, in one of the medium-sized lecture halls, around 30 people sat to hear about some of the projects they had heard a day before hailed as a success

The delegates were divided into two groups: the first was to visit the university’s pharmacology laboratory while the second group was to call on South Africa’s Tuberculosis Vaccine Initiative, a lung infection and immunity laboratory in Worcester

The idea was to give a picture of what exactly the EDCTP money was paying for since 2003 before going to research sites. Most researchers gave an overview of their work and why it was necessary to fund them without regard to time. They talked, talked and talked

The other visit took place in the afternoon with another group of delegates visit to the University of Stellenbosch for TB research presentation by Paul van Helden and Gerhard Walz.

Those who were supposed to tour the laboratory pharmacy at UCT lost the opportunity. There was no time left for their visit. An opportunity had been lost. They then joined others who visited impoverished community of Langa where there are other TB research projects. Nobody seemed to care much about keeping time

New external assistance approach for more research needed urgently

Test_image

Esther Nakkazi
Freelance journalist, SciDev.Net


If Africa is to adequately address some of the disease burdens that have been choking the continent for years on end, a new external assistance approach for more research is not just needed but urgently. These were the humbling thoughts from the Spokesman for the European Parliament at the second High Level Conference on the EDCTP (the European Developing Countries Clinical Trials Partnership)

Nirj Deva, the Conservative MEP for the South East of England and Vice Chair of the European Parliament’s International Development Committee warned that a fresh approach is needed towards international aid

“Every 40 Seconds a child living in Sub-Saharan Africa dies from a mosquito bite. There are 35 million people living today with HIV and this number will only continue to grow. Today, right now, people all over the world live and struggle with abject poverty, hunger and ill health.”
And he rhetorically asked, “How could we have allowed this to happen?” “How did we manage to overlook the fact that one billion people are living their lives lacking the most basic access to fundamental healthcare that we take for granted everyday?” “If we do not help who will?

To him, thinking that this challenge can be overcome by the sheer donation of more aid, more money is nothing but a delusion.  Instead adoption of a more intelligent strategy that takes into account all the factors at issue: “economic development, improved housing, better education and basic healthcare” is imperative

“Quite rightly my taxpayers will demand why we should increase research funding to eliminate diseases that don’t affect them, especially at a time when money is already tight.”
“The answer is simple and not entirely altruistic: Jobs; jobs created in Europe. 13,000 new jobs have already been created in Europe between 2002 and 2010 through exactly such investments in research into poverty related diseases.

This staggering fact means that every Euro we spend to wipe out meningitis, aids, malaria or TB in third world countries, results in increased employment here at home. It is a win – win that could help us out of the recession.”

Nirj Deva concluded his key-note address on Monday stating: “We live in a rapidly developing world defined by unprecedented innovations and opportunities. Yet, unless we act now, today, we will consign not only those already left behind, but their children as well to a continuing struggle for survival. They will never catch up, occupied instead by the need to find water, food, shelter, basic sanitation and medicine. We will have failed them.”

The high level conference that was widely attended by ministers from Europe and Africa as well as notable public and private stakeholders such as the Bill and Melinda Gates Foundation, called for a rise in funds towards the EDCTP, an increase from 400 million to 1 billion Euros