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International Clinical Trials
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Once again, a technological revolution is about to transpire. Just a
decade ago, moving big, complex medical imaging files from one location
to another was a major clinical trial advance. Around the same time, the
International Committee of Medical Journal Editors also made trial
registration a conditional requirement for publication (1). Due to these
innovations and others, so much more can be done as an industry today –
from compliance automation and quality control technology, to patient
acquisition and management. And just as past technological advancements
have had a lot to do with current progress, future ones can help
companies improve in areas where there is still a lot of room for
growth.
Clinical trial regulations have evolved tremendously in
10 years; however, today trials still take too long, data is still lost
or corrupted, and patient recruitment challenges remain. Nonetheless,
this year will undoubtedly introduce a host of new advances that will
get closer to a place where compliance is simpler, participation is
easier, and results are more predictable and structured. The industry’s
hunger for and adoption of new technologies is endless, and the
following areas are a few that are worth keeping an eye on in 2016.
Telemetry Data and Devices
When
the average consumer thinks about a wearable device, a common
association might be the Apple Watch, which connects important data,
phone calls, notifications and music to the wrist, in real time, in a
discreet way. Anyone looking to amplify their health and fitness regimen
will likely think of a Fitbit Charge, Garmin Forerunner or a variety of
other cost-effective wearable devices that monitor health data and feed
that information into a smartphone.
That is not all there is to wearable devices, however; they have the potential to become part of an array of new
technological tools to aid medical research, especially in clinical
trial processes. Nearly 300 clinical trials are now using wearable
devices according to the National Institutes of Health’s records (2) – a
promising but still incredibly small number in comparison to the number
of trials taking place around the world.
The ultra-thin
wearable patch developed out of the University of Illinois at
Urbana-Champaign for example – which measures a patient’s blood flow and
offers critical information about health biomarkers (3) – has the
potential to help physicians constantly monitor trial patients,
providing immediate results within a trial, and further reducing delays
in data collection. The ability to collect more data unobtrusively may
help reduce subject attrition. The challenge lies in what exactly
researchers, trial managers and medical professionals do with the data
to make an impact on clinical trials.
Increased Patient Engagement
While
doctors and researchers may lead the use of wearables in 2016,
successful implementation of such devices ultimately requires interest
from the patient’s side. Fortunately for makers of wearable devices and
doctors eager to utilise them, public consensus is positive. According
to the PricewaterhouseCoopers' Health Research Institute, 56% of US
consumers believe that average life expectancy will grow by 10 years
because of the increased monitoring of vital signs that wearables offer;
46% of US consumers believe wearables will decrease obesity rates (4).
Wearable
devices have the potential to provide a new level of engagement for
clinical trial participants. Similarly, online communities such as
www.patientslikeme.com can empower patients to determine the kind of
research in which they want to participate, opening a new realm of
patient-driven recruitment. This open flow of communications is likely
to positively impact trial registration and encourage subjects who are
in need to voluntarily reach out to the research community for help.
Human-Machine Interfaces
Another
exciting trend that will continue to progress is the tighter
integration of humans and machines. This integration will play out in at
least two ways: collaboration and implants. The collaboration area,
fuelled in a large part by advances in artificial intelligence (AI),
will see robotic helpers learn to infer the intent of patients with
limited mobility or ability to communicate, thus reducing the effort
these patients have to make in order to have successful interactions
with the world. In its simplest form, this may mean that a robot will
get a command to fetch an object, without the person having to explain
or describe all the steps necessary to locate the object, travel to the
object, grasp it, travel back and release it to the patient. With
powerful inference capabilities, these robots will be fully operational
extensions, in both a physical and possibly sensory way, of patients who
would otherwise be unable to care for themselves.
The implant
area brings with it a variety of ethical questions. Earlier this year Dr
Phil Kennedy, a Neurologist, took the exceptional step of undergoing
surgery and getting a colleague to implant electrodes in his brain so he
could carry out his own experimentation with thought-directed
interfaces (5). As the functioning of the brain is increasingly being
understood and signals generated by thought are beginning to be
interpreted, the range of possible inventions opens up exponentially.
With thought-controlled interfaces, developments like exoskeletons
helping quadriplegics and interaction outlets for patients with advanced
amyotrophic lateral sclerosis are suddenly within reach.
Both
AI and implants are predicted to play a vital role in the clinical trial
realm. These may emerge as treatment platforms, drug delivery
mechanisms or technologies to help patients benefit from radically
advanced, complex drugs and devices.
Genetic Engineering
An
emerging area with the potential to disrupt disease control is genetic
engineering fuelled by ‘easy’ gene editing techniques. This is, of
course, as frightening as it is inevitable. Earlier in 2015 saw the $700
Amino home kit enabling people with slightly more than a basic
understanding of chemistry and genetics ‘play’ the gene editing
‘game’(6). And only recently, the FDA approved the first genetically
modified salmon for human consumption. In this particular case, one of
the modifications – making the salmon sterile – ensures that future
‘Frankenfish’ cannot escape and reproduce.
Another experiment
involves editing the genes of milk-producing cows to ensure they do not
have horns (7), which are typically dangerous to the humans that milk
them. But perhaps the biggest disruptor in this area is CRISPR (8),
which makes it more cost-effective and straightforward to carry out
certain gene edits. We are not quite at the level of ‘search and
replace’, but it seems likely that science is headed that way.
Without Delay
The
industry needs to place emphasis on continued innovation and
entrepreneurship; delays and mistakes should be avoided in the process.
It will not come as a surprise if these technologies and services have
an impact on the clinical trial industry in 2016 and beyond, though it
will require a widespread effort to create lasting and significant
change. With the help of some of these technologies and others yet to be
invented, zero-delay clinical trials may no longer be a distant
concept.
References
1. De Angelis C et al, Clinical trial registration: A statement from the International Committee of Medical Journal Editors, Canadian Medical Association Journal, pp606-607, 2004
2. Edney A and Chen C, Big pharma hands out Fitbits to collect better personal data, Bloomberg Business, 2015. Visit: www.bloomberg.com/news/articles/2015-09-14/big-pharma-hands-out-fitbits-to-collect-better-personal-data
3. Webb RC et al, Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow, Science Advances, 2015
4.
Health wearables: Early days, PwC Health Research Institute, 2014.
Visit:
www.pwc.com/us/en/health-industries/top-health-industry-issues/assets/pwc-hri-wearable-devices.pdf
5. Piore A, To study the brain, a doctor puts himself under the knife, MIT Technology Review, 2015. Visit: www.technologyreview.com/news/543246/to-study-the-brain-a-doctor-puts-himself-under-the-knife
6. Stinson L, Amino’s cool bio kit is like the easy-bake oven of bioreactors, Wired, 2015. Visit: www.wired.com/2015/11/aminos-cool-bio-kit-is-like-the-easy-bake-oven-of-bioreactors
7. Regalado A, On the Horns of the GMO Dilemma, MIT Technology Review, 2015. Visit: www.technologyreview.com/node/530416
8. Ledford H, CRISPR, The disruptor, Nature, 2015. Visit: www.nature.com/news/crispr-the-disruptor-1.17673
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CPhI & P-MEC India 2018
12-14 December 2018, India Expo Mart, New Delhi, India
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