1 / 16

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.

apria
Download Presentation

Understanding Clinical Trials

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related