{"id":37146,"date":"2016-08-03T11:31:58","date_gmt":"2016-08-03T10:31:58","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=37146"},"modified":"2016-08-03T11:33:59","modified_gmt":"2016-08-03T10:33:59","slug":"innovations-work-new-tools-for-patients-participation-in-research","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2016\/08\/03\/innovations-work-new-tools-for-patients-participation-in-research\/","title":{"rendered":"Matthias Wienold: Innovations that work\u2014new tools for patients\u2019 participation in research"},"content":{"rendered":"

\"Matthias_Wienold\"Recently I was asked to identify a patient driven innovation for a workshop at the\u00a07th Global Patients Congress<\/a>. The title was \u201cPatient organisation led innovation\u2014what works?\u201d. The innovation I chose is known as community advisory boards (CABs). Such boards are common tools in local and regional organisations of healthcare, but they also exist on national and international levels. I chose to give an example of a CAB created within a patient driven organisation. On this specific platform the pharmaceutical industry, researchers and their networks, regulatory and academic bodies can meet with representatives of the interests of patients.<\/p>\n

Steven Epstein (1996) first noted<\/a> how the impact of AIDS treatment activism on HIV research resulted in \u201cImpure Science.\u201d Patients were fighting for their own rights to break into drug development. In the US community groups started their own experiments, politicised the exclusion and social neglect of people living with HIV\/Aids, and stopped business on Wall Street and at the Food and Drug Administration (FDA). Epstein observed how changes in trial designs, recruitment strategies, and approval processes started to emerge from activists’ proposals and discussions in board rooms.<\/p>\n

In the mid 1990s in Europe we took a different approach to involving patients with HIV\/Aids. At the time the demand for community input and patients\u2019 voices was high across numerous agencies, companies, and physician networks of clinical research. In my role as executive director at the European AIDS Treatment Group<\/a> (EATG) I was often being called upon to provide this patient voice, yet I did not have the personal resources to follow all the invitations. I found it hard to find the time for providing this communication, while also learning from my fellow activists\u2019 experiences. We were being pulled apart by various interests and a wide variety of needs.<\/p>\n

In 1997 I attended a meeting of community experts and ethicists in Bergen. While essentially we were talking about ethics committees and the role of patients on them, we also discussed the benefits of a centralised structure for patient participation. We had the means to inform our communities and to come together in one European group after founding the EATG in 1992. Now we had to develop the skills, rules, and funding for a more structured and meaningful input to the various health systems\u2019 institutions and their players.<\/p>\n

We needed to adapt and scale up the US based idea of a community advisory board attached to a research centre or an institution (W\u00fcrdemann\/Mauss, 1996). The idea was to offer an entirely self-organised patient dominated forum instead of patient representatives running from\u00a0one community board of one company, one research network, or one trial site to another. The aim was also to benefit from more national experiences and perspectives by increasing the number of representatives present at board meetings.<\/p>\n

In 1998 the\u00a0EATG officially launched the first meeting of the European Community Advisory Board<\/a> (ECAB). Since then, the influence of people living with HIV on clinical research and drug regulation has mostly been mediated through this innovative platform.<\/p>\n

The ECAB is a working group of the EATG, which aims to be transparent and accessible to its members, people living with HIV, and their advocates. In its membership the group reflects the diversity of people living with HIV and their advocates. A culture of respect for the diversity of people regarding considerations such as religion, gender, sexual preference, and lifestyle is upheld.<\/p>\n

In pre-ECAB times, the mechanisms for facilitating community participation in clinical research in Europe were ad hoc and patients were engaged for brief periods and specific trials There were some major achievements for the\u00a0EATG (for example,\u00a0opening doors for patients at the European Medicines Agency (EMA)<\/a>, enabling triple combination of experimental drugs, etc),\u00a0but efforts were often repeated; with each new partner the wheel had to be invented anew and we had to find new terms of engagement.<\/p>\n

Since its formation, the ECAB has been responsible for changing trial designs and protocols, monitoring drug development, and supporting its members to participate in data and safety monitoring as they serve independently of the platform on other boards. The ECAB has opened new avenues for research in supporting the D:A:D study<\/a> (which looked at the long term, unwanted effects of antiretroviral therapies) and research that focuses on HIV-Hepatitis and HIV-TB co-infections. It defines itself as a platform for research and development that addresses the issues of patients in clinical research.<\/p>\n

The ECAB working group now has 150 members from 40 different European countries and these members form a network that extends beyond the group. Individual members represent HIV community perspectives and the ECAB\u2019s experience on the European Patients\u2019 Forum (EPF), the EMA, AIDS Action Europe, and the EU Commission\u2019s Civil Society Forum. In addition, members form links and bridges to international health activists and UN institutions.<\/p>\n

The \u201cimpatient patients\u201d (Bereczky, 2014<\/a>) come together\u00a0five to eight\u00a0times a year and the ECAB\u00a0recruits the participants of the meetings from its 150 members.<\/p>\n

The ECAB has formed the basis for specific task forces (for example, on biomedical prevention) and the formation of other working groups<\/a> in the\u00a0EATG, which aim to develop new models of working with partners and an European research policy (for example on women, affordability, training, etc). The model has been copied at national levels in Portugal, Spain, Russia, the UK, and Ukraine. Current research appears to support the idea of a pan-European, cross-disease \u201cAll European Community Advisory Board\u201d (Way et al. 2016<\/a>). The suggestion to institute a translational agency, which can better engage in dialogue with and inform patient communities, shows that\u00a0there is still more that can be done to reinforce the independence and self-governance of patients\u2019 participation.<\/p>\n

Matthias Wienold<\/strong>\u00a0<\/em>is a founding member of the European AIDS Treatment Group (EATG)<\/em>. He was the editor of the <\/em>European AIDS Treatment News 1992-98. He is an elected governing board member of <\/em>the International Alliance of Patients\u2019 Organizations (IAPO<\/em>).<\/em><\/p>\n

Competing interests:<\/strong> I have read and understood BMJ policy on declaration of interests and declare the\u00a0following interests: I am a member of the European AIDS Treatment Group.<\/p>\n

Further reading<\/strong><\/p>\n

Kawaldip Sehmi (2016) \u201cThe 7th Global Patients Congress: Patient engagement in innovation for health<\/a>\u201d<\/p>\n

W\u00fcrdemann, U., Mauss, S., (1996) The Representation of Community Interests in AIDS Research, European AIDS Treatment News (EATN)<\/em>, February 1996, Special Issue.<\/p>\n","protected":false},"excerpt":{"rendered":"

Recently I was asked to identify a patient driven innovation for a workshop at the\u00a07th Global Patients Congress. The title was \u201cPatient organisation led innovation\u2014what works?\u201d. The innovation I chose […]<\/p>\n

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