Reduction of Adverse Drug Events and Readmissions (RADAR-PGX)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Condition or disease
Pharmacogenomic Testing for Medication Management

Detailed Description:

Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	280000 participants
Observational Model:	Other
Time Perspective:	Other
Target Follow-Up Duration:	120 Days
Official Title:	Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine
Study Start Date :	March 2016
Estimated Primary Completion Date :	March 2019
Estimated Study Completion Date :	June 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Radar, Pharmocogenomic [ Time Frame: The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in. ]

   The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when:

   1. A genotype known to affect a drug the patient is taking is identified, *and*
   2. The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.

   Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey.

Eligibility Criteria

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Ages Eligible for Study:	25 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.

Criteria

INCLUSION CRITERIA

Patients may be included in the Study if they meet all of the following inclusion criteria:

1. Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
2. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
4. Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.

EXCLUSION CRITERIA

Patients will be excluded from the Study if any of the following criteria apply:

1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
3. Patient is unable to provide an accurate history due to mental Incapacity;
4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: David Brewer	239-908-0413	Dave.B@Radar-PGxStudy.com
Contact: Diana M Messir	239-908-0412	Diana.M@Radar-PGxStudy.com

Locations

United States, Pennsylvania
MD@Home	Recruiting
York, Pennsylvania, United States, 17402
Contact: Marv Inscore 717-840-8686

Sponsors and Collaborators

MD Global, Inc.

Investigators

Principal Investigator:	Donald Mansfield, MD	VAC
Study Director:	Michael Cohen, PHD	Clinical Research for Professionals

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	MD Global, Inc.
ClinicalTrials.gov Identifier:	NCT02738047 History of Changes
Other Study ID Numbers:	10202016
First Posted:	April 14, 2016
Last Update Posted:	May 19, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided