The European Union needs to play a stronger role in coordinating research into new drugs and should help produce a code of ethics for trials, health officials said last week.
Without a European approach to ethics and testing, patients may have a weaker voice in deciding which diseases are targeted, they argued.
Fragmentation and poor communication among patient groups are major problems for sufferers of rare diseases. Such groups often rely on EU-funded projects to coordinate their work and try to develop common standards for clinical trials.
"Funding for patient groups is needed in order for them to be less dependent on pharmaceutical companies, avoiding conflicts of interest," said Cor Oosterwijk, director of the Dutch Genetic Alliance (VSOP).
Greater patient involvement would increase accountability in the production of new drugs and improve the likelihood of rare, "forgotten" diseases such as multiple sclerosis being treated, he said.
Oosterwijk was speaking at a conference in Brussels last Tuesday/Wednesday (7/8 December) organised by the Patient Partner group, an alliance of 150 patient organisations across the EU.
Patient Partner is drafting a Europe-wide code of ethics for partnership between patient organisations and other stakeholders in clinical research, but health officials warned they will run out of money before the job is done.
Sufferers simply don't have the tools to influence the drug-development process, said Ingrid Klingmann of the European Forum for Good Clinical Practice, who is in charge of drafting the code.
Research in Ireland showed that patients were more likely to participate in clinical trials when they were well informed about the country's ethics code for testing and other information.
No Europe-wide standard currently exists for clinical trials or research, wasting resources and slowing down the development of medicines. This is a particular concern in Eastern Europe, where the number of trials is increasing more than elsewhere.
However, some argue that creating an EU standard to receive funding could create a dual-track system of testing where trials that fail to meet the standard could be labelled "illegal". This could lead to greater risks for patients, who would still be willing to take part in poorly-funded tests, participants admitted.
Regardless, awareness-raising is seen as key to giving sufferers the chance to take part in trials to potentially develop the right drugs to save lives.
"The demand is there," Klingmann said.
Following publication of this article, EURACTIV received the following letter:
The article entitled 'Sufferers want EU ethics code for drug testing' (EURACTIV.com; 14 December 2010) has completely misunderstood the objectives of the FP7-funded project PatientPartner (www.patientpartner-europe.eu) as well as the outcomes of its final workshop entitled 'Patients partnering in clinical trials', held in Brussels on 7 and 8 December 2010, from which the article was generated.
Above all, the PatientPartner project is not working on a Europe-wide code of ethics or a new standard for the conduct of clinical trials as suggested in this article. The declaration of Helsinki provides ethical principles for medical research involving human subjects, including clinical trials. A number of additional guidelines exist and at EU level the standards for the conduct of clinical trials with medicinal products have been set by the clinical trials directive.
The PatientPartner project is working on a document called the Ethical principles of partnership between patient organisations and other stakeholders in clinical research. But this is something quite different. Our approach – as a project seeking to stimulate dialogue between the stakeholders in clinical research – is one of partnership.
Cor Oosterwijk, the PatientPartner coordinator, explicitly told the workshop participants that the ethical principles as presented and debated at the workshop are not meant to be enforced via any EU legislation: 'The document should be persuasive in itself.'
This document will be made part of the guidelines that the PatientPartner project is developing for both patient organisations and the other stakeholders in clinical research on how to engage in meaningful partnerships on a range of levels in clinical research.
Readers might also infer from your article that the outcome of the workshop was a recommendation to seek EU funding for patient organisations. In fact we are looking at ways to separate the partnership relationship from the financial relationship. In this way patient organisations would avoid any unnecessary public criticism concerning a financial relationship with industry, while still being able to work in partnership with this stakeholder to improve clinical research for the benefit of patients.
The joint stakeholders that participated in the final workshop suggested we should look into mechanisms to do so, including setting up a joint funding pot, to which industry, research organisations and governmental organisations could contribute but which would be administered by an independent third party.
You are right in saying that greater involvement of patients would increase accountability in the production of new drugs and improve the likelihood of rare and often ignored diseases being treated. But this does not apply solely to rare diseases: active patient involvement can help set the agenda for clinical research in common disease areas as well. Nor is active involvement in clinical research restricted to influencing the drug development process – it applies to other forms of clinical research such as clinical trials of new treatment methods as well.
As to the use of the term sufferers in this article to describe patients, this term has never been used in the course of the PatientPartner project nor does it rightfully describe patients. Most patients live full lives while dealing with a medical condition, and would not describe themselves as sufferers. In addition, it is not common practice to use this term in the European health policy arena to describe either patients or patient organisations.
You are only partly right in mentioning in the article that 'sufferers' (= patients) simply do not have the tools to influence the drug development process.The PatientPartner project aims to develop the tools needed for all the stakeholders in clinical research to help facilitate the active involvement of patient organisations and their representatives in clinical research.
The dialogues held in the course of the project have pointed to a need - that was agreed on by all stakeholders - to provide training for patient organisations on clinical research methodology. This will provide patient representatives with the opportunity to broaden their knowledge base to help them be actively involved in clinical research in a meaningful way.
As a result we will look into ways to disseminate this recommendation to those parties who are in the position of exploring ways to fulfil this need. But it does not follow that in the meantime patient organisations cannot get actively involved in clinical research. The project has encountered a great number of examples of good practice in which representatives from patient organisations have contributed to the course of clinical research, e.g. by reviewing the protocol for a clinical trial. Patient representatives bring their own expertise to the table – the knowledge they acquire by being a patient, carer or patient advocate on a day-to-day basis. By sharing this patient perspective with stakeholders in clinical research , they can help form the development, conduct and implementation of clinical research, resulting in treatments that will be more representative of patients' real needs.
A final note. With this letter to the editor I hope to have clarified the objectives of the PatientPartner project as well as the outcomes of the final workshop. For any additional information on the project, may I invite readers to visit the project website, www.patientpartner-europe.eu.
On behalf of the PatientPartner consortium, VSOP, EGAN , GA-UK and EFGCP.
The EU's Clinical Trials Directive was implemented in 2004 with a view to improving research standards and protecting patients.
Enhancing the competitiveness of clinical research was a primary concern amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The directive also revamped how researchers get ethical approval for medical trials and sought to improve standards in how new medicines are tested and manufactured.
But the rules were criticised by researchers, who say costs and red tape has increased without bringing any major benefit to patients, researchers or industry (EURACTIV 25/08/09).
The European Commission's current call for proposals to receive EU funding, known as 'FP7', includes opportunities for health research.