Data-sharing should include patient too

By European Alliance for Personalised Medicine (EAPM)  Executive Director Denis Horgan

Genetic research has come on in leaps and bounds over the past few years and has brought with it the potential to change how treatments, medicines and even information to patients is delivered. 

At the heart of genetics-based personalised medicine – aimed at giving the right treatment to the right patient at the right time – lies the collection, storage, use and sharing of data. There is now so much of it that it is termed 'Big Data' and, while it is vital in pushing back the boundaries of medical research, there are many barriers to its optimum and indeed ethical use.  Current research infrastructure, both in Europe and the US, is too compartmentalized which adds cost and slows down the speed of new discoveries.

This can partly, but not wholly, be blamed on proprietary technology but there is also a clear need for greater interoperability, within and between member states. To make the most of all this massive amount of valuable information flowing into super computers and biobanks there needs to be a shared vocabulary and data-set standards, with agreed universal protocols for sending, receiving, and querying the information.

Meanwhile, data storage formats need to be interoperable although, granted, this may prove difficult in a competitive environment such as commercially based pharmaceutical research.  All of this information needs to be interpreted properly too, not least by clinicians working on the front line. One recently released paper across the Atlantic stated that: “Doctors are no longer the experts they once were,” and added that it has been calculated that physicians would have to read for 640 hours per month to keep up with all the advancements in medicine.

This situation will only get worse, thanks in part to all this new data. The paper added that: “In the future, health care is likely to be two parts data, one part doctor.” This underlines the fact that it is vital that clinicians are educated to understand what new treatments are available, what direction the data should send them in and, crucially, communicating this to the patients in a clear, non-patronizing manner in order that the latter are aware of their options and can become truly involved in the decision-making process in respect of their own health.

Solid but realistic rules on data privacy are crucial and are currently being fiercely debated in the European Union. The Brussels-based European Alliance for Personalised Medicine (EAPM), for example, is of the firm belief that patients should have control over their own data, be given choices about its usage and that the necessary laws protecting them do not go too far to the point of putting a strangle-hold on research that would benefit the health of all of the EU’s 500 million potential patients. There is, of course, no doubt that data privacy is hugely important.

In America, since 2010, insurance companies have not been permitted to change their health-plan rates to take into account genomic data. And, two years earlier in the same country, employers were barred from weeding out potential employees based on their health data. This is one form of necessary protection. On another – vital – note, patients need to be able to see their own personal data, yet this is seldom the case at the moment. Data donors should be able to access the raw data derived directly from their stored sample, as well as be able to choose where and how it is used. There are clear ethical reasons for this, yet it is very much still a one-way street.

Data co-operatives may well provide the answer and achieve the goal of giving decisions back to the donor, while any financial rewards that flow into the cooperative can be used to advance research in ways that the donors choose. But currently, a patient donating personal data to a data bank or biorepository is rarely able to access the basic descriptors of his or her own contribution: The raw data, directly from the deposited sample before analysis, are usually not made available. EAPM, with a multi-stakeholder base that includes many patients’ groups, believes that this is an unacceptable state of affairs. Data are often shared and used by a large number of researchers but the individual donors have the least access to the data they contribute, yet low cost, user-friendly internet-based tools are available to allow them this access.

These systems should be built into new repositories on day one, or the costs will soar through the necessity of adding them later. In essence, the ability of patients to be able to access their own raw data is a basic requirement for a fair and reciprocal relationship and allows data donors and/or patients to make their own, considered decisions. It empowers them and gets them truly involved in their own healthcare, which they certainly should be.   At the bottom line, patients are often better informed about their own condition than the doctor in this modern era and that fact cannot be treated lightly. Having access to their data will also give patients the option of independent analysis – the famed ‘second opinion’. In the end, patients need to be taken seriously as partners in research - as well as partners in the surgeries of their doctors and the decisions that are made there.

Share this article: