Clinical trials: patients willing to make their data available to benefit other patients.
Less concerned about privacy and much more interested in recovery from illness and solidarity with others, cancer patients in 6 countries are willing to disseminate clinical data about their illness.
This is what happens with clinical trials. Italian privacy legislation (Legislative Decree No. 196 of 30 June 2003) contributed significantly to ensuring respect for a patient's right to confidentiality, which was vociferously demanded by them and by charters establishing patient rights.
Not being identified with their illness, not having their data supplied to third parties, safety distances in interviews, careful and consensual use of medical information and records are all well-established rights now in the collective conscience of this country. And so is the right to transparency and so-called accountability. Clinical trials aimed at finding new treatments for serious diseases, primarily cancer, are particularly important in this respect. European clinical trial databases are now available and Italy has its own national clinical trials observatory at AIFA. Many problems remain, however, as a result of which the European Union is discussing the text of a new Directive which contains and updates these elements associated with confidentiality and transparency. I have neither the space nor the expertise to go into the content of the various Italian and European provisions. I would therefore like to talk about the part that interests me the most: sick people.
What do patients think about the results of the clinical trials they undergo being published? During an international meeting of the PACE (Patient Access to Cancer care Excellence) Global Council organised by Lilly in New York on 9th November, the results were presented of a survey that is yet to be fully published were presented and the survey was conducted by GFK in 6 countries (Italy, Japan, UK, France, Germany and USA). The data shows a general "public willingness to take part" in the field of clinical trials. The most interesting findings relate to the distribution of data and medical electronic records for general interest purposes. Respondents stated they were in favour of information being disseminated that would be useful to them and others. The great majority of respondents (general public, patients and caregivers) stated that, if it can be useful to improve the chances of their treatment succeeding, they are willing allow their records and the results of tests they have undergone to be shared among doctors and researchers and, if it can help other patients, they are equally willing to make their data available. Less certainty is expressed about the guarantees that their data will be stored correctly and that their identity will be redacted.
This is extremely good news and signals a willingness on the part of the general public to participate in the results of research. The public want to ensure that their data will serve a purpose and help others, and that doctors can hold discussions on data they can all share, rather than being jealously hidden, in order to determine which treatment is more effective for patients, while obviously respecting the established confidentiality requirements.
This spirit of solidarity and "practicality" is important in a world such as that of clinical trials, where people are primarily the object of experimentation and are dominated by strong entities, such as the scientific world, big pharmaceutical companies, public institutions, which dictate the rules. Has the time come to consider patients and the general public as entities on an equal footing as the others?
By Teresa Petrangolini, Director of ACN