Patient organisations are driving change in clinical research

Advances in medicine are possible only with the voluntary participation of patients. Patients therefore have a moral right to be involved in how research is developed, managed and evaluated. But research is still largely seen in paternalistic terms as something that is «done to» patients, rather than «with patients» – so the focus of regulation is traditionally on protection of the (passive) subject, rather than empowerment of the active participant. Patient groups see the revision of the EU clinical trials regulatory framework as a key opportunity to change this.

Patient-centred regulation

The outcome will guide clinical research in Europe for years to come, so it is vital to get it right. Patients play a central role; it is they who provide the information and will have to manage the personal risks involved; and it is they who are the ultimate beneficiaries of success.

Patients need to be seen as equal participants in, rather than mere subjects of, research. Their involvement should be embedded throughout the entire chain of research .The European Parliament has taken a forward-looking stance particularly in two key areas of the Regulation, largely as a result of advocacy by patient groups.

Ethics review is critical to ensure that a trial produces knowledge that is of high quality and that the design of the trial is ethical. Patients’ involvement has shown to improve the quality of ethics review. However, most research ethics committees do not include patients, and some are still reluctant to recognise the value of patient involvement. The European Parliament has now taken the view that patient involvement in ethics committees should be mandatory, with best practice guidelines to be drafted at European level. The report is due to be voted on in plenary session in March 2014.

Informed consent is another area of concern. Consent is still too often regarded as a «tick box» exercise rather than a vital means of empowerment which should enable a patient to make an informed choice in whether or not to participate in a trial.

Patient groups have long pointed to the unacceptable differences in both quality and quantity of information given to trial participants, depending on where in the EU they happen to live. We have successfully called for a common standard of quality for information to patients and informed consent, and this to be developed at European level with the input of patients.

Involvement supported by capacity building

It is worth stressing that involving patients in clinical trials assessment is not enough. Involvement has to start before research priorities are defined. This is where patients have the potential to become «drivers» of research that will result in real improvements to their peers and the wider society.

Empowering patients to get involved in research requires training to support their participation in scientific discussions and address the inherent imbalance of power between the «expert» and the «lay person». Those involving patients also need training and support. Some tools and good practices already exist, through the VALUE+ and PatientPartner projects and this is also the focus of the European Patient Academy on Therapeutic Innovation. (http://www.patientsacademy.eu/index.php/en/about-eupati)

Patient organisations are engaging at the highest level to push for political change, but all actors involved in research need to take responsibility and play their role. Investigators, sponsors and funders, whether in academia or industry, need to see patients as partners and their involvement in clinical trials development as a precondition rather than an «optional extra». Regulation alone is not enough to achieve this, but it provides a legal framework that we hope will contribute to a shift in the culture of medical research.

 

Kaisa Immonen-Charalambous

Senior Policy Adviser European Patients’ Forum, Belgium
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