Clinical trials are research studies that test new medical interventions and therapies on human volunteers. They are led by a principal investigator and research team and aim to contribute to medical knowledge. Participants in clinical trials help evaluate potential new treatments, but there are also risks involved. It is important to carefully review the protocol, risks, benefits, and commitments required for any clinical trial.

1. Clinical
Trials:
How
to
find
them
&
What
you
need
to
know
Jennifer French, MBA
Executive Director
Neurotech Network
Abilities Expo: San Jose November 2013

2. www.NeurotechNetwork.org
Helping people regain life thru neurotechnology
Focusing on education of and advocacy to access
neurotechnology devices, therapies and treatments
for people living with impairments, their care-givers
and medical professionals.
Abilities Expo: San Jose November 2013

3. Disclaimer
page
The
informa6on
presented
in
this
session
is
not
meant
to
replace
the
advice
from
a
medical
professional.
You
should
consult
a
health
care
professional
familiar
with
your
specific
case,
concerns
and
condi6on.
Neurotech
Network
and
its
representa6ves
do
not
endorse,
rate,
sell,
distribute,
prescribe,
administer
or
recommend
any
products,
procedures
or
services.
We
highly
suggest
for
you
to
take
informa6on
to
a
trained
medical
professional
familiar
with
your
case
to
discuss
op6ons
that
are
best
for
you.
Abilities Expo: San Jose November 2013

4. What
is
a
Clinical
Trial?
www.ClinicalTrials.gov
A service of the US
National Institutes
of Health
Abilities Expo: San Jose November 2013
• Research involving human
volunteers (participants) that is
intended to add to medical
knowledge.
• Lead by a principal investigator
• Research team may include:
doctors, nurses, social workers or
other health care professionals
• May be sponsored or funded by
companies, academic medical
centers, voluntary groups, federal
agencies and other organizations.

5. Funding
Aboody et al , 2011. Neuron. 70:597-613.
Abilities Expo: San Jose November 2013

6. Types of Clinical Trials
Interventional Studies
Observational Studies
source: www.clinicaltrials.gov
Abilities Expo: San Jose November 2013

7. Why are Clinical Studies
Conducted?
Comparative
• Evaluate 1 or more intervention
Prevention
• Find ways to prevent the
development or recurrence
Diagnosis
• Identify ways to diagnose,
condition or risk factor
Improve
• Explore or measure ways to
improve comfort or QOL
source: www.clinicaltrials.gov
Abilities Expo: San Jose November 2013

8. How is it different from
Usual Health Care?
Clinical
Study
Specific
goal
Strict
Protocol
Abilities Expo: San Jose November 2013
Usual
Health
Care
Care or
monitor of
condition
Flexible for
treatment

9. Basics: Clinical Study Participant
Protocol Information
1)
2)
3)
4)
5)
6)
Reason for conducting the study
Who may participate in the study (eligibility criteria)
Number of Participants needed
Schedule of tests, procedures, or drugs and dosages
Length of the study
What information will be gathered about the participants
source: www.clinicaltrials.gov
Abilities Expo: San Jose November 2013

10. Basics: Clinical Study Participant
Eligibility Criteria
Inclusion
Eligible
Exclusion
Expanded
Access
source: www.clinicaltrials.gov
Abilities Expo: San Jose November 2013

11. Considerations
Contribute to
medical
knowledge
Basis for new
development
Commitments,
time and
money
Potential direct
treatment but
also risks
Follow the
protocol
source: www.clinicaltrials.gov
Abilities Expo: San Jose November 2013

12. Highlights:
 Technology
 Lessons Learned
Abilities Expo: San Jose November 2013

13. Enabling technology: Implanted
 Implanted Receivers
 Implanted Receiver
Stimulator (IRS) 8 ch
 Implanted StimulatorTelemeter (IST) 16 ch
 Electrodes
 Intermuscular electrode
 Multicontact spiral cuffs
 Universal External
Control Unit
Abilities Expo: San Jose November 2013

14. Standing & Transfers System
• Targeted Muscles
• Erector spinae
• Gluteus Maximus
• Gluteus Medius
• Adductor Magnus
• Semimembranosus
• Gastroenemius
• Tibialis Anterior
• Femoral Nerve
Abilities Expo: San Jose November 2013

15. Lessons Learned
It takes a team
Have fun
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Become part of
the research team

16. Lessons Learned
- Know your rights & risks
- Read the fine print
- Informed Consent
-­‐
Understand your
commitments
Abilities Expo: San Jose November 2013

17. Lessons Learned
Abilities Expo: San Jose November 2013

18. Lessons Learned
• Manage your expectations
• What happens when it is over?
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19. Questions to Ask
 What is being studied?
 Why do researchers believe the
intervention being tested might
be effective?
 Why might it not be effective?
 Has it been tested before?
 What are the possible
interventions that I might
receive during the trial?
 How will it be determined which
interventions I receive (for
example, by chance)?
Abilities Expo: San Jose November 2013
 Who will know which
intervention I receive during the
trial?
 How do the possible risks, side
effects, and benefits of this trial
compare with those of my
current treatment?
 What will I have to do?
 What tests and procedures are
involved?
 How often will I have to visit the
hospital or clinic?
source: www.clinicaltrials.gov

20. Buyer Beware
 Medical Tourism
 Faulty Clinical Trials
 Hope for $Money$
 No Oversight/
Reporting
Abilities Expo: San Jose November 2013

21. Resources
 www.ClinicalTrials.gov:
Na>onal
Library
of
Medicine
&
Na>onal
Ins>tutes
of
Health
 www.nih.gov/health/clinicaltrials/
NIH
Clinical
Research
Trials
&
You
 www.nlm.nih.gov/medlineplus/clinicaltrials.html
MedlinePlus®Clinical
Trials
Informa>on
 www.nhlbi.nih.gov/childrenandclinicalstudies/
Children
&
Clinical
Studies
 www.fda.gov/ForConsumers/
Clinical
Trials
&
Drug
Development
Abilities Expo: San Jose November 2013

22. www.NeurotechNetwork.org
www.OnMyFeetAgain.org
Abilities Expo: San Jose November 2013

23. USA
Paralympic
Sailing
Team
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24. Abilities Expo: San Jose November 2013