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Too Focused on Patients?


Graham Hughes reviews the DIA Clinical Forum, which took place in The Hague from 8th to 10th October

The conference was entitled ‘The Empowered Patient’. The theme was clearly chosen since the evolution of technology and electronic communication tools has given patients the ability to find health information, which may have a significant impact on their choice of treatment. Patients are now able to communicate and connect easily with each other, especially through websites such as Facebook and patientslikeme.com, and are empowered to become more engaged in their care and participate in their care decisions.

A number of sessions addressed patient involvement in clinical research and the emergence of the so-called ‘ePatient’. Presenters also discussed the human rights of patients in the context of clinical research and healthcare in general. While it was contended that patients have the right to expect to be treated with effective medicines and to be protected from harm, a question asked was: “Do they also have the right to expect access to information and to modern innovative medicines?”

I first attended the DIA Clinical Forum in Nice in 2009; the programme of the 2012 conference was barely recognisable from the programme of three years ago. To some extent this reflects the changes taking place in clinical research management, but also the change in emphasis of the organisers of the current forum and its theme of the empowered patient.

The eight themes of this year’s conference were:
  • Patients
  • Clinical research
  • Clinical operations
  • Drug safety and risk management
  • Peri- and post-approval studies
  • Medical information and communications
  • eClinical and clinical data management
  • Validation

The conference closed with a plenary debate, the motion being ‘This house believes that patients are not fit to be informed participants in clinical research’. There was also a plenary session on the second afternoon, entitled ‘Patients on trial’, both of which were reasonably well attended (although I suppose that the plenary session was a device to persuade delegates to stay for the final morning of the conference).

A poll held before the start of the debate was overwhelmingly against the motion despite the two proposals. Professor Alyn Morice, Head of the Division of Cardiovascular Studies at Hull Medical School, and Valdo Arnera ARN ER, General Manager of PHT Corporation, presented persuasive arguments in favour of the motion. The opposition, Nikos Dedes, from the European AIDS treatment group, and Pauline Evers, from the Federation of Cancer Patient Organisations in the Netherlands, spoke movingly about how patients can participate in the design and organisation of clinical trials, yet failed to convince the audience that patients actually taking part in clinical trials were fit to be fully informed. The final vote by the audience showed a distinct switch in opinion so the motion was only narrowly defeated.

In general, there was a significant emphasis on patients suffering from rare diseases; so much so that one delegate commented that perhaps patients with common diseases were being a little ignored. One speaker noted that there were over 750 organisations in Europe supporting patients suffering from rare diseases and that advocates from these organisations were often members of ethics committees or EMA committees, which gave scientific advice on disease protocols. Other talks discussed whether you could randomise a non-interventional study (you can’t), but you can undertake conjoint analysis using randomised questionnaires, which was de facto randomisation. David Pau from Roche discussed quality assurance in non-interventional studies where it was found that there were no well-established procedures, there were a limited resources and a great concern about data privacy. Dr Hartmann, a Senior Consultant, noted that what had previously been called Phase 4 studies were the fastest growing area of clinical research. He proposed a renaming of these studies to ‘post authorisation studies’, either for evaluation or safety assessment.

The plenary session, Patients on Trial, was a disappointment in that the two speakers very much concentrated on the Dutch experience. The session was in the form of a panel discussion with questions from the audience and these, in my experience, rarely work in large forums. Later, Hannah O’Gorman of Exco gave a very interesting presentation on the use of mobile phones for clinical research and discussed how they could improve patient engagement and compliance. Dr Ian Gessler of EUPATI showed how patients, their nurses, doctors and even family members, have very different views on what constitutes ‘quality of life’. Dr Costello of EURODIS, described a major European initiative that will enable hospitals and patients to monitor their personal disease progression in comparison with the rest of that disease community.

David Stein of Perceptive Informatics discussed what he called ‘virtual clinical trials’ where the site was virtual, and showed how these trials could be more efficient than the traditional trial. Dr Pierre-Yves Lastic of Sanofi-aventis discussed the innovative medicines initiative of the EU details of which can be found at the website EH4CR.EU.

I came away from the meeting a little disappointed in the content of the conference. As I mentioned above, there seemed to be too much concentration on patients with rare diseases and very little on the actual operation of clinical research and any innovations that are taking place today – apart from the use of mobile phones in the talk by O’Gorman. The next DIA Clinical Forum will be in Dublin in 2013 and perhaps the meeting will go back to being more of a clinical research forum, and less of a forum for the patient, and thus more relevant to industry delegates.

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