Bringing Brussels and Africa Closer on Trials

Last September, this column looked at the prospects for support to clinical trials, in Europe and in Africa.

Peter O’Donnell

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 (EDCTP).

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.

Not just Africa

The EDCTP initiative is not the only victim of the failure to agree the European Union's future funding plans. A series of plans to give financial support to clinical trials in Europe, agreed in principle as a good thing a year or more ago, is also on hold, because these plans too are held hostage by the paralysis over strategic spending. The EU ambition to put some $100 billion behind a new European research program—in which health is one of the priority areas identified, with some very specific provision for clinical trials—is stuck in the same logjam as the EDCTP second program.

So all the fine talk last year about funding for "the development of better methodologies to allow trials to focus on relevant population groups, including those suffering from other concomitant diseases and/or already undergoing treatment," have so far come to naught. The same is true for plans for "the determination of comparative effectiveness of interventions and solutions," for "enhancing the use of databases and electronic health records as data sources for trials and knowledge transfer," for "improvement of cross-cutting support technologies for drugs, vaccines, and other therapeutic approaches, including transplantation, gene, and cell therapy."

Embattled new rules for the EU

Meanwhile, things are still moving only slowly on the European Union's bid to update its clinical trials rules. As already (indeed repeatedly) remarked in this column, the European Commission's proposal of last July has yet to command universal support. Ireland, the incoming presidency in the European Union's rotating chair for the first half of this year, pledged in its program to "make progress on the proposal for a regulation concerning clinical trials on medicinal products for human use." It remarked that "this proposal is designed to address the fall in clinical trial applications in Europe, which are essential to providing new innovative medicines for patients and maintain a strong pharmaceutical industry, by reducing the administrative burden and costs on sponsors, while at the same time ensuring that subjects are fully protected." But it has found that the discussions it chairs in the EU Council are tough work.

Many member states feel that the commission proposal is just too glib, requiring, as it does, that they should do all the hard work at national level—in reaching a single opinion on every application for a clinical authorization—while the European Union will then take the credit for a smoother system to which it will, in effect, make only a minimal contribution on each application. The risk is that the entire legislative process may be held up by demands for a fairer share-out of the workload, with national authorities seeking that the commission should, for instance, take a more overt role in defining procedures for authorization, and the commission sticking to its view that member states should sort out their own national procedures.

The problem now springs from the fact that EU legislation has to fit the rhythm of broader EU governance processes, and fresh elections to the European Parliament are due in mid-2014. For new rules to go through, the parliament will have to give its approval to whatever deal might emerge to resolve these divergences, and that could take months. Given that parliament's interest in current business falls off as the pressure for electoral campaigning rises, a real race to the finish is in prospect, even if member states and the commission find a compromise. And if the proposal does not get passed by parliament before parliament dissolves for elections, it is likely to be declared dead—and the whole process will have to start again in late 2014 or beyond.

By their nature, clinical trials are geared to demonstrating future benefits. Any benefits from EU moves in support of clinical trials seem, at present, to be well into the future—so far in the future as to be very hard to see.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.