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

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  • 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 Abilities Expo: San Jose November 2013 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? Abilities Expo: San Jose November 2013
  • 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   Abilities Expo: San Jose November 2013
  • 24. Abilities Expo: San Jose November 2013