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Patient Trial Finder

Patient Trial Finder. 10/20/2010 Dr. Raymond Lord, Bill Dumais, Mike DeBari. High-Level Process. Pre-requisites : Diagnosis, Lab Work Done, 1 st Treatment not available/helpful, Staging Patient Education/Understanding of Trials

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Patient Trial Finder

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  1. Patient Trial Finder 10/20/2010 Dr. Raymond Lord, Bill Dumais, Mike DeBari

  2. High-Level Process • Pre-requisites: Diagnosis, Lab Work Done, 1st Treatment not available/helpful, Staging • Patient Education/Understanding of Trials • Realistic Location, Performance Status(high), Lab Work(Kidney/Liver/heart), • Discuss with Provider (eligibility) • Primary Onc Provider Trial Involvement, (7week lead time), Review protocol/elig. Criteria, testing (& refreshes), referral/ patient care transferred? , radiation, surgical intervention? • Search for Trial • All trials or local trials or other specifics • Patient offers trial consideration, financial considerations, no formal authorization from primary oncologist, • Make short list of potential trials • process may be ongoing and iterative. • Contact the Clinical Trial Personnel • Labs/images required? • Go through a checklist of what is required of the trial • different standards across similar trials • schedule , side effects reviewed with patient • consent form (coaching) • Ask Questions/Review Trial • Schedule, tour, education • Discuss Options with Provider • Role of external investigator? • Schedule an Appointment to Join the Trial

  3. Base Questions We need to expand on the clinical trials narrative, specifically to find potential clinical trials for a patient after the cancer staging step. Kelly suggested that after the cancer is staged, the oncologist be offered a list of clinical trials that fit for which the patient may be considered. The list would be based on the cancer diagnosis, staging, and patient clinical profile. The system should be able to offer some assistance in determining the financial eligibility of the patient for the trial and the appropriateness of the trial dependent on co-morbidities. Some of the questions or features that the system might offer that we discussed are:1. Can I see a list of study protocols so I may consider involvement?2. Can I see a list of study protocols that fit?3. Provide case report forms associated with this study4. Can you confirm that my patient matches eligibility check for the protocol5. Can I find out NEXT STEPS?6. Can I keep track of activities?7. How do I notify a patient withdrawal from the study?8. What will happen if for some reason the study is halted?9. What audit trails can I see of each sites participants in this study?10. Are there complete audit trails of all sites participants in this study? Question: (Regarding tumor staging in general) is there patient education component for tumor staging? Kelly stated that there are patient education materials concerning the patient’s diagnosis and cancer stage, but that it is not handed out with staging activities.

  4. Additional Questions • Questions from Mike... • Can trials be registered but not yet ready for enrollment? That is, would there be a need to notify a patient of the opening of a trial for his/her enrollment? (waiting list?) • Is it ever recommended to apply to more than one trial? • what is a typical waiting period for acceptance? • Can enrollment be conditional on someone else withdrawing? • What are the activities to be done after a trial is targeted by patient? • Does a patient's request for more information commonly/occasionally/never transgress any license issues(e.g. access to a journal, reprint from a book, etc) • How would it be best for the discussion/advice from caregiver on trial(s) merits be captured for patientconsideration over days/weeks?

  5. Patient Perspective -What do the researchers hope to answer in their study -Risks vs. benefits -Cost (some trials are free) -How many participants needed? Already involved? -How have the other participants responded so far ? "If 19 patients have been treated, and you are patient No. 20, clearly you should ask whether the treatment worked on your predecessors. If it was not effective for all 19, researchers still need a 20th patient to complete the trial. Researchers would not be obliged to tell patients that the trial didn't work for the first 19 people, since they would only suspect the treatment was ineffective.

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