Last September, this column looked at the prospects for support to clinical trials, in Europe and in Africa.
Things don't move very fast in the European Union, and many of those prospects remain just that—prospects. But at least one
element slotted into place at the end of January to give shape to a promise to help clinical trials in Africa. Researchers
from the continent's sub-Saharan countries are going to have better chances of upgrading their clinical research skills after
the European drug industry signed a memorandum of understanding with the European & Developing Countries Clinical Trials Partnership
What the deal will offer, as from later this year, is a series of research fellowships in pharmaceutical companies in Europe
for clinical and non-clinical staff from the region. Each company will design a customized program that reflects its own activities
and expertise, and the field of interest of each trainee, and will include short- and long-term goals as well as clearly defined
ethics and compliance rules.
The fellowships will be awarded through open calls for proposals. Candidates will be selected by EDCTP, and those who are
selected will be able to spend up to two years in a company, very largely a company of their choice.
The memorandum spells out the rationale for the initiative. It says that the research-based pharmaceutical industry "has developed
skills related to clinical trials that cannot be acquired through academic training or medical/scientific practice." It makes
the point that within European-based pharmaceutical companies, crucial activities "are performed to a very high standard,"
citing study design, biostatistics, data management, project management, study monitoring, report writing, regulatory submissions,
and audits. The intention, therefore, is to offer sub-Saharan African scientists who are actively involved in clinical research
projects the opportunity to gain hands-on experience in a pharmaceutical research setting.
The full details of the scheme will be released in February, but the outline conditions are that candidates should have a
guaranteed position at their home institution, adequate skills, and experience—which will be assessed on a case-by-case basis—and
will be expected to return to their home institution for a minimum of two years after completion of their training. EDCTP
will cover travel and subsistence costs. The companies that take part in the scheme will donate time spent by tutors, materials,
and access to internal training opportunities, and up to €5,000 for a fellow's business travel, such as to attend conferences.
Richard Bergström, the Director General of the European Federation of Pharmaceutical Industries and Associations, said at
the signing ceremony that the arrangement was an opportunity for companies as well as for researchers from Africa. "EFPIA's
members will benefit from interaction with African scientists from diverse backgrounds beneficial to the development of new
or improved treatments in poverty-related diseases." At the same time, "We hope to help them acquire skills relevant to achieving
their research and professional goals."
Professor Charles Mgone, EDCTP Executive Director, said it was "critical that more African researchers are sufficiently trained
and equipped with skills and expertise in clinical trials research in the fight against diseases that severely impact the
social and economic development of sub-Saharan Africa." He declared himself "delighted" with the deal.
He might well do so. Because it is at least one concrete result from so much talk about the merits of, and need for, support
to medicines research in and for developing countries. Some of the other initiatives are taking a long time to bear fruit.
As Mgone himself commented at the signing ceremony, the deal with EFPIA companies will reinforce collaboration in the recently
agreed EDCTP program—the second phase of this 10-year old initiative. That is, as and when the second phase can really start.
Because this was one of the promising prospects that brightened the future of EDCTP during 2012—as Applied Clinical Trials commented in September. Unfortunately, the broader context for turning that promise into reality (which is, in crude terms,
largely a question of money) remains inchoate. The overall EU spending plan for the next seven years should have been agreed
last year, and any meaningful action in the EDCTP's second phase depends on precisely that agreement for most of its funding.
But dissension about how much to put into the general purse persists among austerity-hit EU member countries—over issues more
related to payments for farmers or allocations for regional development, rather than the relatively obscure area of clinical
trials in poorer countries. And this is delaying the necessary strategic consensus on how much the European Union will spend
on anything that happens between the end of this year and the end of the decade.
The new fellowship scheme has been created in cooperation with the European Commission, which has repeatedly declared its
interest in promoting international standards for conducting clinical trials, and in boosting research capacity in Africa.
And at present, that is about all the European Commission is able to do until it is given a clearer view of future spending
plans by the leaders of the national governments that ultimately call the shots in the European Union. So for all the noble
aspirations to see the second EDCTP program make new progress in the development of treatments, vaccines, and diagnostics
for HIV/AIDS, tuberculosis, malaria, and neglected infectious diseases, right now the best bet is to get a few researchers
a few months in the clinical development divisions of a few drug firms in Europe.