Clinical	
  Trials:	
  

How	
  to	
  find	
  them	
  &	
  
What	
  you	
  need	
  to	
  know	
  
Jennifer French, MBA

Exe...
www.NeurotechNetwork.org
	
  
Helping people regain life thru neurotechnology
Focusing on education of and advocacy to acc...
Disclaimer	
  page	
  
The	
  informa6on	
  presented	
  in	
  this	
  session	
  is	
  not	
  meant	
  to	
  replace	
  t...
What	
  is	
  a	
  Clinical	
  Trial?	
  

www.ClinicalTrials.gov
A service of the US
National Institutes
of Health

Abili...
Funding

Aboody et al , 2011. Neuron. 70:597-613.

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

Abilities Expo: San ...
Why are Clinical Studies
Conducted?
Comparative

•  Evaluate 1 or more intervention

Prevention

•  Find ways to prevent t...
How is it different from
Usual Health Care?
Clinical
Study

Specific
goal
Strict
Protocol

Abilities Expo: San Jose Novemb...
Basics: Clinical Study Participant
Protocol Information
1) 
2) 
3) 
4) 
5) 
6) 

Reason for conducting the study
Who may p...
Basics: Clinical Study Participant
Eligibility Criteria
Inclusion

Eligible
Exclusion
Expanded
Access
source: www.clinical...
Considerations
Contribute to
medical
knowledge

Basis for new
development

Commitments,
time and
money

Potential direct
t...
Highlights:
 Technology
 Lessons Learned

Abilities Expo: San Jose November 2013
Enabling technology: Implanted
  Implanted Receivers
  Implanted Receiver

Stimulator (IRS) 8 ch
  Implanted Stimulator...
Standing & Transfers System
•  Targeted Muscles
•  Erector spinae
•  Gluteus Maximus
•  Gluteus Medius
•  Adductor Magnus
...
Lessons Learned
It takes a team

Have fun

Abilities Expo: San Jose November 2013

Become part of
the research team
Lessons Learned
-  Know your rights & risks
-  Read the fine print
-  Informed Consent

-­‐	
  Understand your
commitments...
Lessons Learned

Abilities Expo: San Jose November 2013
Lessons Learned
•  Manage your expectations
•  What happens when it is over?

Abilities Expo: San Jose November 2013
Questions to Ask
  What is being studied?
  Why do researchers believe the

intervention being tested might
be effective...
Buyer Beware
  Medical Tourism
  Faulty Clinical Trials
  Hope for $Money$
  No Oversight/
Reporting

Abilities Expo: ...
Resources	
  
  www.ClinicalTrials.gov:	
  Na>onal	
  Library	
  of	
  Medicine	
  &	
  
Na>onal	
  Ins>tutes	
  of	
  He...
www.NeurotechNetwork.org
	
  

www.OnMyFeetAgain.org
Abilities Expo: San Jose November 2013
USA	
  	
  
Paralympic	
  
Sailing	
  
Team	
  

Abilities Expo: San Jose November 2013
Abilities Expo: San Jose November 2013
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Clinical Trials: How to find them & What you need to know

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Clinical Trials: How to find them & What you need to know

  1. 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. 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. 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. 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. 5. Funding Aboody et al , 2011. Neuron. 70:597-613. Abilities Expo: San Jose November 2013
  6. 6. Types of Clinical Trials Interventional Studies Observational Studies source: www.clinicaltrials.gov Abilities Expo: San Jose November 2013
  7. 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. 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. 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. 10. Basics: Clinical Study Participant Eligibility Criteria Inclusion Eligible Exclusion Expanded Access source: www.clinicaltrials.gov Abilities Expo: San Jose November 2013
  11. 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. 12. Highlights:  Technology  Lessons Learned Abilities Expo: San Jose November 2013
  13. 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. 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. 15. Lessons Learned It takes a team Have fun Abilities Expo: San Jose November 2013 Become part of the research team
  16. 16. Lessons Learned -  Know your rights & risks -  Read the fine print -  Informed Consent -­‐  Understand your commitments Abilities Expo: San Jose November 2013
  17. 17. Lessons Learned Abilities Expo: San Jose November 2013
  18. 18. Lessons Learned •  Manage your expectations •  What happens when it is over? Abilities Expo: San Jose November 2013
  19. 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. 20. Buyer Beware   Medical Tourism   Faulty Clinical Trials   Hope for $Money$   No Oversight/ Reporting Abilities Expo: San Jose November 2013
  21. 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. 22. www.NeurotechNetwork.org   www.OnMyFeetAgain.org Abilities Expo: San Jose November 2013
  23. 23. USA     Paralympic   Sailing   Team   Abilities Expo: San Jose November 2013
  24. 24. Abilities Expo: San Jose November 2013
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