The advent of new technologies for clinical trials and availability of
“Big Data” provides an enormous opportunity for researchers, but
many challenges still remain. Investigational teams should keep in
mind that e-technologies are simply additional types of research
tools not intended to completely supplant traditional methods, particularly
given the need for more empirical evidence. Newly released
technologies require time to be tested and refined to overcome challenges.
Future research can expand our knowledge of the impact of etechnologies
on clinical trial design and interpretation, particularly in
respect to validity of results, randomization and blinding. When determining
whether to integrate e-technologies into clinical trials, one
may want to consider 1) the target population and their access to and
preferences for specific e-technologies, 2) how technology may change
during the time it takes to conduct the trial, 3) whether methods will
be compliantwith regulations on the use of e-technologies, 4) the available
infrastructure to process large volumes of data, and 5)whether the
e-technologies introduce additional and/or unnecessary risks to subjects'
privacy or confidentiality. Investigators should partner with professionals
from multidisciplinary knowledge areas (e.g., engineering,
information/computer science, business) and patients to address the
variety of challenges involved in integrating e-technologies in clinical
trials. Careful planning will not just help with a successful implementation
of the clinical trial, butwill increase the chances of the usability and
sustainability of the studied technology after the end of grant funding.