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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
Cancer still a primary focus of EMA in light of COVID and vaccine development.
While Europe and its citizens, like much of the rest of the world, continue to reel under the assault of COVID-19, the focus of many health authorities is understandably on vaccines, and the related research, development and–particularly as 2021 gets underway–production issues. But work is nonetheless continuing on planning for the health challenges that will still be there even when COVID-19 is under control. Late January saw Emer Cooke, the new executive director of the European Medicines Agency, fresh from a tough debate on vaccines in the European Parliament’s health committee, switch her attention to cancer, with an appearance at another of the parliament’s specialized committees.
Cooke was speaking at the parliament’s temporary committee on cancer, which has been set up specially in response to Europe’s Beating Cancer Plan–one of a number of health initiatives now emerging from the EU. Establishing her credential with the committee, she pointed out that EMA had approved 116 new cancer medicines over the 26 years of its existence, and in 2020 alone this included 11 products with new active substances–about a quarter of the 39 cancer medicines approved during the year.
The many challenges she identified in cancer medicine development are matched, she said, by “many solutions that we can see from our perspective.” And at the top of her list was improving clinical trials collaboration with downstream decision makers, as well as providing support to innovation. And she had some clear ideas on how this should be done, with a powerful emphasis on patient benefit as a priority.
In her view, “when talking about supporting innovation, we need to make sure that clinical trials are designed to answer the right questions.” For her, this means appropriately designed trials that not only promote innovation, but that also address the needs of cancer patients. “It’s only in this way that will be able to meet the evidence needs of regulatory authorities and downstream decision makers such as health technology assessment bodies, insurers, healthcare professionals and patients.” Cooperation is needed with those decision makers, and to ensure transparency of processes, and that requires better communication of information.
The focus must be on “trials fit for purpose from a patient perspective, and that ensure that patient views are systematically considered through the development process.” This is all the more true when research is confronting the particular challenges of rare and pediatric medicines, she underlined. But she saw this could be an opportunity, a chance for the EU to optimize the research effort by ensuring access to clinical trials and facilitating participation in them.
While remaining diplomatic, Cooke left no ambiguity in her estimation of the current degree of coordination at European level. “To do this we need to leverage the resources for conducting high quality research in Europe.” There is insufficient access to clinical trials—“and if we don’t facilitate access these trials just take too long to conduct.” At present, she pointed out, the majority of trials are conducted in only a handful of EU countries, and often only in a few centers. “There really are opportunities to bring trials closer to EU patients by promoting and enlarging the development of competences and trial readiness across Europe,” she said.
She also favors encouraging collaborative clinical trials by leveraging interaction between academia and scientists linked to regulatory bodies. This, she said, is necessary to address rapidly emerging regulatory science research questions, and to make a reality out of the concept of treatment optimization. “The EU needs to support clinical research into cancer treatment optimization with respect to all important clinical outcomes, real world effectiveness and safety. This will help to identify the population that is most likely to benefit. The continuation of data generation is necessary to inform the optimal use of medicines and the choices of patients and doctors,” she argued.
As she emphasized, clinical trials and drug development do not stop when a product is approved or reimbursed. “Evidence generation is a continuum which helps us to refine the understanding of what is the optimal use of new cancer medicines in clinical practice.” This she sees as a major opportunity for the EU to develop a learning healthcare system, which can maximize data generation in the real world by federating data from different sources–such as electronic health records and cancer registries. Regulators have a particular role in this, by identifying the open issues and helping to design the research questions that are needed.
But, she acknowledged, this needs the right infrastructure for systematically collecting, federating and sharing key data from different sources–and at present that is something lacking in Europe. That is why EMA is collaborating with the European Commission in the creation of the European health data space–another of the EU’s new initiatives.
It is also time to “refocus on designing quality into clinical trials.” For her, this includes applying risk proportionate approaches that systematically involve patients and a wide range of stakeholders in trial design. She said that EMA, along with other international regulators in the International Council of Harmonization, are making progress on this through updating of the fundamental good clinical practice guidelines for clinical trials.
Better communication could also decrease time lags and differences of view between approval decisions by regulators and access decisions by health technology assessment bodies. That in turn will benefit from progress on the EU’s now long-delayed HTA regulation, which should widen the scope for EMA to engage with HTA bodies. The right changes to pharmaceutical legislation–also up for EU review in 2022–and smarter regulatory practices can provide tools to help incentivize innovation. It should be possible to shorten review times, to make more use of priority schemes for innovative medicines, and targeted support through orphan designation.
“We are fully committed to delivering on the ambition of creating an enabling environment for the development, evaluation and access to new and re-purposed cancer medicines in the EU, and we stand ready to support the implementation of the European Beating Cancer Plan,” she concluded.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium