European Forum for Good Clinical Practice (EFGCP) conference: Virtual Future: An exploration of the ethical dimensions of emerging technologies in clinical trials and research

28th January 2013 No Comments

I was invited to chair a workshop with a very interesting topic: Conducting Clinical Trials on the Internet. This is such a perfect topic for us that I gladly accepted the invitation. The ‘ethical dimensions’ of this topic gives us the right mindset from the start – the patient’s perspective. Patient-centric conduct of clinical studies is a hot topic at the moment, but what does it mean in practice and do we really understand what the patient’s perspective is?

In the context of this topic, there are some conclusions that can be drawn based on what we know about how people use the Internet today:

  • As of June 2012, there were 2,405,518,376 Internet users globally
    • 48.4% of these come from Asia
  • Penetration in the global population was 34.3%
    • North America leads with 78.6%
    • Europe 63.2%
    • Asia 27.5%
  • 80% of users have searched for health information online
    • Already in 2006, 7% of Americans search for health information daily – this activity is as popular as paying bills online!

Personally, the number of users from Asia surprised me. Living in Europe, it feels like computers are everywhere and almost all the people I know are connected. Subconsciously this clearly has made me assume most of the users would also come from Europe and North America. In fact, Europe and North America only account for 32.9% of the global Internet population.

Internet penetration is also a very interesting metric. In many countries, penetration is already very high, considering the figure probably includes the whole population. Some countries, such as Finland, have made broadband Internet access a civil right and by 2015, access to a 100Mb/s will be a legal right for every citizen. At the same time, only 15.6% of the people in Africa have access to the Internet.

Based on this, we can conclude that people are used to searching for health information online and we can assume this extends to clinical trials as well. The Internet is the most efficient tool to reach out to large populations across the globe.

The trouble is that most clinical trials today are not:

1)   Meeting patient expectations about efficient conduct of the study and providing them with information and engagement tools that they are used to in other aspects of their life, such as banking or consuming information 

Instead of electronic tools and materials, patients are still presented with binders of paper and required to attend physical site visits, sometimes only to complete paper forms.

Does this present them with the image of top-quality, health-saving critical research that will motivate them to stay engaged and compliant? I don’t think so.


2)   Utilizing the potential of the Internet. If there are billions of people online, why are we not bringing them in as research participants through the Internet?

There is plenty of evidence that paper-based methods are not efficient and often yield poor results. For example, paper diaries are known to have poor compliance and poor data quality when compared to electronic diaries.

Is it because of lack of suitable technologies? Clearly consumer technology advances at a much more rapid pace than research technology. PDA / smartphone –based electronic diaries have taken off only in the past few years despite being available for much longer time. While there are some solutions for online patient recruitment or some other individual aspect of a trial, these systems tend to be completely isolated, stand-alone websites and only bring limited value to the research. In my opinion, these technologies need to work closely with existing research systems and processes. Some systems, such as ePRO are a good example of this.

Of course, with great potential there are also many issues to consider. For example, to what extent does the lack of accessibility or computing experience bias the populations? I can certainly understand the concern, but let’s take a moment to consider:

  • In many countries, the % of mobile-only users already exceed the number of desktop internet users. For example, in Egypt 70% of users only use the Internet with their mobile phone.
  • The emergence of user-friendly touch-screen user interfaces has brought down the usability barrier. Most modern tablets and smartphones are already easy enough to be used by virtually anyone from the 2-year olds to the elderly.

The use of any technology is likely to have some level of bias in the study. However, I actually think that the bias of NOT using the right technology is going to have a far greater effect. The ‘tech-savvy’ population is likely to be so turned off by a clumsy paper-based approach that will increase their burden that they might not want to participate at all. I think we’re past the tipping point where the disinterest from large populations of tech users will be more significant overall than the effect of the populations who are tech-averse.

In summary, I think this is a fascinating topic and the impact of Internet technologies on the ethical, quality and scientific issues of clinical studies should be discussed further in the future. We at eClinicalHealth will stay very close to this topic as we are working on a completely new and innovative solution to providing this kind of technology into clinical trials in the near future. Stay tuned for more about that.

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