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The potential for transformation within the clinical research process is here and now. Are you ready?
"e Health means Information and Communication Technologies (ICTs) tools and services for health. Whether eHealth tools are used behind the scenes by health care professionals or directly by patients, they play a significant role in improving the health of European citizens."1
This statement from the Europe Information Society synthesizes a very complex and topical scenario in which the discussions about sustainable costs of welfare and health care cross with the progressive implementation of telemedicine services. In addition, it addresses the increasing role played by patient associations and overall trends of patient empowerment.
Illustration: Paul Belci Photography: Getty Images
José Manuel Barroso, president of the European Commission, speaking at the opening ceremony of the CeBIT Trade Fair in March 2008 stated: "We see the emergence of the next generation Internet, ICT components, and applications, and of new mobile services. The benefits of ICT innovation spread across the whole of society and economy, having a direct impact on our competitiveness: eGovernment, eCommerce, eBusiness, eInvoicing, eAccounting, eHealth, to name just a few."
In May 2007 the FDA issued the "Guidance for Industry: Computerized Systems Used in Clinical Investigations" and the Information Society and Media Directorate General of the European Commission supports the initiative "good eHealth,"2 a knowledge base showing 100 routine eHealth solutions taken from 30 European countries. The Commissioner Viviane Reding said in her comment, "The information gathered...clearly shows that eHealth does matter, that it is well worth the investment, and can lead to very substantial benefits."
These few examples provide evidence that ICTs already have a role in health management. There is no doubt that eHealth and the innovative Web services, which are already changing our approach to the Internet, will also impact clinical research and the way clinical trials are carried out.
The Internet is already used often in the clinical research environment, such as providing updated information on the industry and clinical trials in particular. These include the FDA, the National Institutes of Health, the EMEA, different national Medicines Agencies, private for-profit companies such as CenterWatch and Veritas, pharmaceutical companies, and patient associations.
In addition, ICTs have a pivotal role in the daily management of clinical trials. Technologies such as Remote Data Entry or Electronic Data Capture (EDC), not particularly reliable many years ago, are now widely used and may contribute to large economic savings in a study. In this area, the Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, nonprofit organization that has established standards to support the acquisition, exchange, submission, and archiving of clinical research data and metadata. Its mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health care.3
The Good Clinical Practice rules recognize the use of electronic systems for the Case Report Form, but the most interesting advances have been observed particularly in the patient diary area. This so-called "eDiary" has shown to be practical, reliable, and user friendly for many, including children and the elderly. The improvement of data collection from the patient by means of electronic Patient Reported Outcomes (ePRO) has provided a direct measurement of signs and symptoms, giving particular importance to the subjects' experience.4 ePRO can provide consistent standards, precise readability, and better adherence to the study protocol, while greatly improving the quality and timing of the statistical analysis. Also, ePRO results have high rates of compliance among the elderly. Challenges associated with impaired hearing, vision, and manual dexterity also can be overcome by well-designed technology.5
The area in which ICTs may play a significant role in clinical research, however, is the field of telemedicine. ICTs offer the potential of monitoring systems that subjects can wear while going about their daily business, or which can be carried around easily and used regularly at home. Such systems and tools can provide reliable data on multiple parameters (ECG, heart rate, blood pressure, blood sugar, respiratory parameters), with transmission to remote locations. This would allow medical professionals to make decisions on treatment without requiring an in-person visit. Furthermore, they give the same advantages described for the eDiary in terms of precision, protocol adherence, and compliance with medicines.
Another very interesting field concerns teleradiology, which may allow the integration of clinical data with X-rays also taken at home, with minimal discomfort for the subject and an added value of centralized reading and archiving for the clinical trial.
There are many different stakeholders in clinical research—regulatory bodies, the pharmaceutical and medical device industry, opinion leaders, investigators, and CROs—but the role of the subject is becoming increasingly important. In part, the subject's empowerment in the health care decision-making process became possible thanks to ICTs and the Internet. Patients can now find reliable medical and disease-specific information, search for reference doctors and hospitals, and actively participate in managing their disease.
To mention just a couple of examples, the UK Clinical Research Collaboration (UKCRC)6 is taking a dual approach to working with patients and the public by:
The National Cancer Institute's Cancer Information Service (CIS)7 is a national information and education network in the United States. The CIS provides the latest and most accurate cancer information including information on research to patients, their families, the public, and health professionals.
In these and many other cases of local and international institutions and associations, the Internet has been instrumental. It assures the most updated and reliable information consistent with the HON (Health On the Net) Code of Conduct (or HONcode) for medical and health Web sites8 and helps transition from a general "informed consent" to a real "aware consent."
We are in the era of Enterprise 2.0, as described in 2006 by Andrew McAfee,9 in which Web-based companies
promote the use of "social software" or collaborative software that allow users to interact and share data with other users. Specific social software tools that have been adapted for enterprise use include hypertext and unstructured search tools, wikis, Weblogs for storytelling, social bookmarking for tagging and building organizational folksonomies (social classification), RSS for signaling, collaborative planning software for peer-based project planning and management, social networking tools, and tools for visualization.10
The Enterprise 2.0 platform is based on six salient characteristics, which McAfee refers to as SLATES:
In this way, people become the engine of the system, breaking down the entrance barriers to collaborate, whatever their role and position within or outside the company.
These User Generated Content (UGC) tools are already in use for different social networking purposes and include Flickr, YouTube, Wikipedia, eBay, LinkedIn, del.icio.us, blogs, and others. The basic concept is the reciprocity between the user and the provider: People can upload as well as download, and they turn out to be "prosumers" (i.e., producers and consumers).
Why shouldn't all these tools used in daily life be a substantial part in the conduct of clinical trials? We can imagine the collaboration of best experts in the clinical or methodological field using the wiki software to build the study protocol. We can create a Web site, password protected as needed, to communicate the information on the trial to investigators and patients. The Case Report Form may be filled in online and, in case of doubt, may have hyperlinks that take users directly to the relevant protocol page as well as to an inclusion and exclusion criteria checklist used for subject recruitment. A blog may gather and convey the voice of the investigators and the patients, allowing to pick up extremely important pieces of information on the investigational medicine (efficacy and side effects) that might be lost if left to the occasional visits of the monitor at the investigator site.
The study Web site could also podcast or Webcast interviews with opinion leaders, best-practice examples (videos, pictures, and X-rays using the tagging method), as well as the most updated information on the results of other trials. A study dedicated Web site can also provide doctors with up-to-date information on the disease for which the investigational drug is under evaluation. In addition, investigators may post their opinions and best results, and find study documents, information from authorities, guidelines, and scientific articles. Using the "Web feeds" system, investigators or patients may register with an aggregator program (a feed reader) that runs on their own machines. When instructed, the aggregator asks all the servers in its feed list if they have new content and downloads it.
In this way, the new technologies contribute to not only the development of science but also to the dissemination of scientific culture and have an important educational result.
"We are only in the middle of the beginning of a revolution that is transforming humanity."11 We have the power of information of the so-called Web 1.0, Web 2.0 (interaction between persons), and the incoming Web 3.0 (the network of the objects that will interact with each other, with the servers, and with the people—in our case the physician).
Many different tools already used in other fields may radically change the scenario of clinical trials. In the future, our environment will be full of "things that think,"12 with a great diffusion of intelligent objects and a broad use of nanotechnologies, supported by a very high-speed permanent connectivity and a seamless man–machine interaction. Converging technologies describe the meeting of new and potentially disruptive technologies such as nanotechnology, biotechnology, cognitive science, robotics, and artificial intelligence that will help mankind in improving health and overcoming disability.
However, ICTs must not be considered as a substitute to usual health care. They must remain a complementary tool to be used by sensible physicians and health professionals. eHealth is not only a system to provide health care at a distance, it has to be seen as a system concerning the health care organization and human resources management, education and training, and high quality standards.
The Web services described here will influence the clinical research scenario and will change the relationship between the pharmaceutical industry, health professionals, regulatory authorities, and patients. But we all have the responsibility to keep control of them and treat them properly, as we would do with a fine horse who has to be our friend, but never take the lead. No technology should ever replace the human touch and the personal involvement between the doctor and the patient. In a word: "more high tech and more high touch."13 Notes
This article represents the author's own views and does not necessarily reflect the views or policies of the Italian Ministry of Health.
Carlo Donati, MD, is medical advisor at the directorate general, information system, at the Ministry of Health, Via Giorgio Ribotta, 5, I-00144 Rome, Italy, email: email@example.com.
1. Europe's Information Society Thematic Portal, "Health: Better Healthcare for Europe," http://ec.europa.eu/information_society/activities/health/index_en.htm.
2. Good eHealth, http://www.good-ehealth.org/index.php.
3. Clinical Data Interchange Standards Consortium, http://www.cdisc.org/index.html.
4. The Importance of Patient-reported Outcomes...It's All About the Patients, http://www.fda.gov/fdac/features/2006/606_patients.html
5. Invivodata, "ePRO Solutions for Clinical Trials Research," http: //invivodata.com.
6. UK Clinical Research Collaboration, www.ukcrc.org/.
7. National Cancer Institute, Cancer Information Service, cis.nci.nih.gov/index.html.
8. Health On the Net Foundation, www.hon.ch/HONcode/Conduct.html.
9. A. McAfee, "Enterprise 2.0: The Dawn of Emergent Collaboration," MIT Sloan Management Review, 47 (3) 21-28 (2006).
10. Wikipedia, "Enterprise Social Software," en.wikipedia.org/ wiki/Enterprise_social_software.
11. Gerry McGovern, "Web History: Middle of the Beginning," www.gerrymcgovern.com/nt/2007/nt-2007-12-17-web-history.htm.
12. ThingsThatThink, Research Highlights, ttt.media.mit.edu.
13. European Commission—Information Society and Media, Accelerating the Development of the eHealth Market in Europe, eHealth Task Force Report 2007.