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Understanding Clinical Trials

Understanding Clinical Trials. Laurie Bernstein MS RD FADA Associate Professor Director of IMD Nutrition University of Colorado Denver NPKUA July 2012. Disclosure. I am a member of the Nutricia Elements advisory board.

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Understanding Clinical Trials

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  1. Understanding Clinical Trials Laurie Bernstein MS RD FADA Associate Professor Director of IMD Nutrition University of Colorado Denver NPKUA July 2012

  2. Disclosure • I am a member of the Nutricia Elements advisory board. • I am involved in Kuvan and PEG-PAL clinical research funded by Biomarin. • I have current educational grants from Biomarin and Nutricia.

  3. The Role of Clinical Trials • Research study done to evaluate new potential treatments in people • Before a new treatment is available to the general public: • Carefully studied ( study drugs have been studied in labs and in animal studies are now deemed safe) • Human studies are referred to as clinical studies Clinical Study – gain more info to see if the study drug is safe and effective and to look at both risks and benefits in people.

  4. **Important** • When we begin talking to you about a study, a lot of work has already been done to develop a PROTOCOL

  5. PROTOCOL • Study plan • Specific details of what will happen in the clinical study Study: precise carefully designed KEY PURPOSE: Safeguard the health of the participants

  6. Design of the protocol • Specific research question that the study is designed to answer • We cannot answer this question without YOUR participation

  7. The protocol describes the following information: • Who may participate in the study? • Exact schedule of tests • What procedures are involved • What the study drug is • Dose • Nothing is random – No personal preference

  8. Another important point • Significant guidelines: • if not, the study is not a success • You can discontinue: • no consequences I would say make sure that you have checked off the boxes that address your concerns. Then you can comfortably start this and finish this.

  9. Risk and benefits • Side effects • Requirement of study • Strict adherence • Extra clinic visits • Extra blood draws etc. • Medical care –more interaction • You are helping with medical research • Future generations

  10. Important questions before agreeing to participate • Purpose • Who is doing the research • Why do researchers believe it will be effective • Length of the research • What kind of tests will be involved • Daily life • Birth control • Safety • Access to t he treatment after the trial • Costs

  11. What happens to the information that is collected • Confidential • Some info: IRB/ FDA/ Health Canada • Name never • Initials/dob/ethnic background/study code • Know this info before consent

  12. Placebo • Looks like the study drug but it does not have the medicine in it. • Inactive liquid or powder • No treatment value • Double blind • Eliminates power of suggestion • Keeps the research honest

  13. Staying organized • Reminder system that works best for you. • Daily calendar • Stickers • Beep on the phone • Apps • Ask for encouragement

  14. Who is my contact person • Best number • First visit • How do I get there • Bring • Park • Reimbursed

  15. Resources • www.clinicaltrials.gov • www.Medlineplus.gov • www.patientpower.info • What to consider in assessing a clinical study • CD’s available at the Biomarin booth

  16. Thank you • To our patients whose commitment and bravery make the future of PKU management a reality. • Blake Shewey • Partners for Medical Education

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