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Whose Data is it Anyway?

With increasing pressure from patients, governments and regulatory authorities, pharmaceutical companies are being forced to increase their transparency, making trial data more open and widely available.

In this age of information availability and increasing desire of individuals to take ownership of their own data in an effort to make better informed healthcare decisions, is the drug development industry doing enough to keep pace with the demand for data availability and transparency? Are recent calls from governments and regulatory agencies for the industry to ‘open its doors’ enough to satisfy the demand for transparency and meet with the needs of the general population?

Industry, Government Legislation and Politicians’ Promises

The British Medical Journal (BMJ) published a hard-hitting editorial on 3rd January 2012, calling for greater transparency in clinical trials, including the publication of results for trials that were not successful. “…A large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis – we are simply talking about the absence of data,” Richard Lehman at the University of Oxford and Elizabeth Loder of BMJ wrote (1). The editorial goes on to state that the consequences of this missing data could harm the well-being and safety of patients, and potentially add futile costs into the healthcare systems.

The BMJ editorial is the latest in a series of industry-based articles, editorials and publications that have begun to clamour for increased transparency and availability of clinical trial data. The issue of patients’ rights to their healthcare data is also becoming more mainstream, as evidenced by a recent article entitled ‘Patients at risk after scientists withhold test results from clinical trials of new medicines’, which appeared in the Daily Mail, the UK’s second largest newspaper, which had picked up on the BMJ editorial.

In February 2000, the Food and Drug Administration (FDA) Modernisation Act (1997) created a national clinical trials registry for federal and privately supported trials (Clinicaltrials. gov). With the FDA Amendments Act of 2007, provision was made to mandate the publication of a results summary within 12 months for all clinical trials in the US “initiated or on-going as of September 2007”. A recent study, published in the BMJ as part of its editorial, looked at compliance with this reporting requirement and found that only 163 out of 738 (22 per cent) that were mandated to report results had results published within 12 months of completion (2).

In the first quarter of 2011, in an effort to make clinical research more visible to healthcare providers, research communities and patients, the European Medicines Agency (EMA) launched an online register giving public access to clinical trials in the 27 European Member states. At this time, however, the register does not publish summaries of clinical trials, unlike According to the European Commission, the aim is to have this included in the European register by late 2012.

Even politicians are recognising the benefit of opening up the industry and are pushing for data transparency in an effort to further develop and invest in the life sciences sector. In early December 2011, David Cameron presented ambitious new plans to revolutionise and make accessible the data archives of the UK’s National Health Service in what is being termed the ‘NHS-Life Sciences partnership’, suggesting that “every NHS patient should be a ‘research patient’ with their medical details ‘opened up’ to private healthcare firms.”

While the approaches of the US and European regulatory agencies to open up the hitherto secretive realm of clinical trials are laudable, expedited progress is highly unlikely. In the US, mandatory legislation is already in place and yet less than 25 per cent of required trials are compliant. In a fiercely competitive and ever challenging market, worth in excess of $50 billion globally, it is no surprise that there may be a reluctance on the part of pharmaceutical and healthcare development corporations to provide open access to research and data into which they themselves have invested billions of dollars and many years (3).

Then There was eClinical

One sector of the clinical research industry that is investing heavily in the idea of data transparency is the various service organisations that support pharma, biotech and device development companies. Among the many new concepts and buzz words being touted in conferences and articles, one keeps recurring – ‘eClinical’; defined on Google web definition as “a term used within the biopharmaceutical industry to refer to electronic systems for automating the management or conduct of clinical trials with the aim of replacing manual, ad hoc or paper-driven methods.” Upon first glance this seems a reasonably comprehensive and all-encompassing definition; however, when you begin to deconstruct it, questions arise. Is it a new system? Is it many systems? Is it a new version of an existing system? Is it process design? How is it a different way of working or conducting trials? Is it supposed to be more efficient? How does this benefit me or my organisation?

Look at the websites of service organisations and each will have their own definition, most centred on the implementation of a single or suite of products aimed at reducing the number of systems utilised while providing data faster to sponsors. But is this a more efficient way of operating, or are processes, carved from stone in prehistoric times, now simply ‘eClinicalised’ the way early adopting EDC systems were literally just paper CRFs in an electronic format?

Some service organisations are investing in a more holistic eClinical approach towards making technology, systems and processes work in a much more integrated manner, promising ‘faster access to your data’, ‘greater transparency’ and ‘integrated solutions to your clinical needs.’ This is accomplished through a variety of solutions, such as rolebased portals with real-time alerts and notifications, electronic document exchange and integrating systems from multiple vendors. eClinical, in its purest form, should be an approach to running clinical trials through new methodologies, innovations and pushing boundaries. It should be about making technology fit efficient processes and providing data faster, enabling the sponsor companies to bring products to market quicker and publish results sooner. Ultimately, eClinical should be about providing more complete and comprehensive data transparency into the public arena.

So if regulation and legislation have so far failed to pressurise the industry into providing greater public transparency, what will?

And then Came the ePatient

Patients are progressively assuming more responsibility for their healthcare decisions, and this is especially true in regard to participation in clinical trials, where they are turning to online resources and organisations for information. In this movement, ‘ePatients’ are beginning to recognise the potential power of social networks and the internet to become an unanticipated force in the world of healthcare and clinical research. In 2009, the National Health Interview Survey found that 51 per cent of adults aged 18-64 had accessed the internet to research health information in the preceding 12 month period (4).

To service the appetite of ePatients in taking a more active role in their healthcare decisions, a multitude of web-based organisations and services have arisen. The Society for Participatory Medicine and Open Notes are two organisations encouraging the concept of ‘participatory medicine’ amongst patients, promoting access to their medical information so that patients themselves can become actively involved and empowered. While in the grand scheme of things both organisations are small in terms of online communities, they are beginning to attract increasing attention and support both from the patient community and from healthcare providers that are recognising the benefits of information exchange and sharing.

There are other online entities that are more actively connected with the clinical research industry, which ultimately may have a bigger impact on shaping data transparency and access. Both, and are online social network communities, but with a different approach. Patients participating in both of these communities are encouraged to share more than just opinions or informal conversations with others suffering from similar ailments. They are encouraged to provide much more structured and personal information. This is shared not only with each other but also with the company running the website. These websites utilise eforms that are almost indistinguishable from electronic CRFs and in some cases, ironically, much easier to use than industry EDC systems. This information is also accessible to industry partners who are willing to pay for it. In the case of, they have a clear and open statement on their website about how the business makes money by sharing information “about your experience with the disease and sell[ing] it to our partners (companies that are developing or selling products to patients)”. What is not clear is how much of this data is sold to other organisations to further clinical research and development, how much is sold to further improve the effectiveness of drug marketing campaigns, and what validation of the data is in place.

Then there are the ‘grey areas’ of data transparency and information sharing, which may have consequences on how the future of openness evolves in a digital age. There is increasing anecdotal evidence of online forums and discussion groups where patients that are either actively involved in clinical trials, or those that are looking for more information, have conversations about side effects, how to meet eligibility criteria, what sort of assessments/interventions are required and how effective the patients believe the trial to be. Of course many of those patients may not even know if they are actually receiving active or study medication in a lot of instances. Further tales abound of ‘disease awareness’ communities on the major social networks such as Facebook and YouTube where seemingly independent communities discuss various conditions and treatments, but in reality the page has been commissioned and or moderated by a drug or biotech company, but without corporate branding and public awareness.

Data, Data Everywhere, nor Any Byte to Use

Even though clinical trial results are available, in part, to the general public, there is no guarantee that the average person is able to understand and interpret these results. Guidelines on non-technical clinical trial reports need to be established so that the information from these trials is used in a productive manner. What types of conclusions are members of the public making if they are misinterpreting results and making health decisions based on the misinformation? And who, ultimately, is responsible for providing this information to the patient – the Principal Investigator that established the relationship with the patient, the drug companies that publish the results or the regulators that are legislating for transparency?

In a survey carried out by The Centre for Information and Study on Clinical Research Participation, “volunteers responded positively to a proposed post-trial newsletter with clear explanations of the study procedures, the results, and other research opportunities. Participants who reported feeling completely under-informed or overwhelmed by Googleretrieved websites when they tried to search for results on their own welcomed the prospect of a personalised report. Almost all saw some form of post-trial information as integral to a satisfactory participation experience” (5).

While governments, regulators and the industry work towards greater data transparency, they are being outpaced by a growing public appetite for access to health data. If that data is not readily available, or in a format that is easily consumed by individuals without requiring expert medical knowledge, then the public will find alternative sources, either within their own communities or from the expanding number of unregulated online organisations.

In order for unencumbered public access to safe and reliable data, data transparency must be a coordinated, industry-wide response as pioneered by service organisations adopting initiatives such as eClinical. It is inconceivable to think that the regulators and drug development companies will continue to be outpaced by other online medical influences, providing less qualified advice and information to the ePatient communities. They need to react quickly and with innovation to fully embrace the growing demand for patient data transparency.


  1. Lehman R and E Loder, Missing clinical trial data, BMJ 344: d8158, 2012
  2. Prayle A, Hurley M and Smyth A, Compliance with mandatory reporting of clinical trial results on Cross sectional study, BMJ 344: d7373, 2012
  3. The Pharmaceutical Industry in Figures – Key Data 2011 Update, European Federation of Pharmaceutical Industries and Associations
  4. Cohen R and Stussman B, Health information Technology Use Among Men and Women Aged 18-64: Early release of Estimates from the National Health Interview Survey, January – June 2009, Health E-Stats, National Centre for Health Statistics February 2010
  5. Visit:

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Gareth Adams is a Director of eClinical Solutions and Global Director of Clinical Data Management at PRA. In his 16 years of professional experience he has held a number of senior management positions and since 2010 has been involved in process design and optimisation, strategic visioning, talent management and change leadership. He graduated with honours in Biological Sciences from the University of Plymouth before starting his career with Theorem (formerly Omnicare Clinical Research), working as a Data Analyst in a predominantly paper based environment. Since then, Gareth has strived to introduce technology and innovative process solutions in each of the roles he has held during his career. Email:

Melissa Nezos is currently a Director of eClinical Solutions at PRA. Since graduating from San Diego State University with an MSc in Neuropsychology, Melissa has worked for a number of organisations within Clinical Operations and Senior Management including CRA, Project Manager and Director of Clinical Operations. For the past 18 months Melissa has brought her clinical knowledge and expertise into the eClinical Solutions environment, working on organisational and process change, technology integration and innovative clinical monitoring and data quality strategies. Email:
Gareth Adams
Melissa Nezos
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