clinical trials: how to find them & what you need to know

Abilities Expo: San Jose November 2013

Clinical Trials: How to find them &

What you need to know

Jennifer French, MBA Executive Director

Neurotech Network


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.


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.


What is a Clinical Trial?

•  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.

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

of Health


Funding

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


Types of Clinical Trials

Interventional Studies

Observational Studies

source: www.clinicaltrials.gov


Why are Clinical Studies Conducted?

•  Evaluate 1 or more intervention Comparative

•  Find ways to prevent the development or recurrence Prevention

•  Identify ways to diagnose, condition or risk factor Diagnosis

•  Explore or measure ways to improve comfort or QOL Improve



How is it different from Usual Health Care?

Specific goal

Strict Protocol

Clinical Study Care or

monitor of condition

Flexible for treatment

Usual Health Care


Basics: Clinical Study Participant Protocol Information

1)  Reason for conducting the study 2)  Who may participate in the study (eligibility criteria) 3)  Number of Participants needed 4)  Schedule of tests, procedures, or drugs and dosages 5)  Length of the study 6)  What information will be gathered about the participants



Basics: Clinical Study Participant Eligibility Criteria

Inclusion

Exclusion

Eligible

Expanded Access



Considerations

Contribute to medical

knowledge

Potential direct treatment but

also risks

Follow the protocol

Commitments, time and money

Basis for new development



Highlights:  Technology  Lessons Learned


Enabling technology: Implanted

  Implanted Receivers   Implanted Receiver

Stimulator (IRS) 8 ch   Implanted Stimulator-

Telemeter (IST) 16 ch

  Electrodes   Intermuscular electrode   Multicontact spiral cuffs

 Universal External Control Unit


Standing & Transfers System

•  Targeted Muscles •  Erector spinae •  Gluteus Maximus •  Gluteus Medius •  Adductor Magnus •  Semimembranosus •  Gastroenemius •  Tibialis Anterior •  Femoral Nerve


Lessons Learned

Have fun

It takes a team Become part of the research team


-‐ Understand your commitments

-  Know your rights & risks -  Read the fine print -  Informed Consent

Lessons Learned


Lessons Learned


•  Manage your expectations

•  What happens when it is over?

Lessons Learned


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)?

  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?



Buyer Beware  Medical Tourism

  Faulty Clinical Trials

 Hope for $Money$

 No Oversight/Reporting


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


www.NeurotechNetwork.org

www.OnMyFeetAgain.org


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clinical trials: how to find them & what you need to know

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