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The Importance of Patients Perspectives: Patient Reported Outcome Measures
The Importance of Patients Perspectives: Patient Reported Outcome Measures
What are late-phase clinical studies and why are they important?
Late-stage clinical studies are postmarketing trials classified as Phase IIIb and Phase IV that are conducted to establish a drug’s long-term safety and efficacy following regulatory approval, and to provide product differentiation and positioning in the competitive drug [...]
Recruiting and Retaining Clinical Trial Patients
Recruiting and Retaining Clinical Trial Patients
By Dave Betz, Dana Betz and Diane Leahy – OmniTrace Corp.
What is a major area of concern and associated consequences in clinical trial conduct?
Clinical trial failure is a major concern, as 80% of failures are caused by the inability of research sites to find and enroll sufficient patients and meet [...]
Burden of Patient Dropouts and Patients Lost-To-Follow-Up On Clinical Studies
Burden of Patient Dropouts and Patients Lost-To-Follow-Up On Clinical Studies
By Dave Betz, Dana Betz and Diane Leahy – OmniTrace Corp.
Patient dropouts/LTFU implications
In any clinical trial, patient retention, issues of patient dropout and those lost to follow-up (LTFU) poses a major challenge. Each patient represents a significant amount of time, effort and other resources, so [...]
Important Considerations in Clinical Research and Pharmacovigilance
Important Considerations in Clinical Research and Pharmacovigilance
With an overall goal in protecting public health, the objective of pharmacovigilance (PV) is to promote the safe clinical use of medicines and prevent adverse drug reactions from clinical investigation throughout post-marketing of a drug. While there are multitudes of factors that affect a PV program, the focus of [...]
Electronic Medical Records Utility in Clinical Trial Conduct
Electronic Medical Records Utility in Clinical Trial Conduct
Patient dropouts and those lost to follow-up (LTFU) pose a major challenge and costly burden in the conduct of clinical trials as each patient represents a valuable source of data. High patient dropout rates are not only costly but pose a risk to the interpretation and validity of [...]
Clinical Trial Conduct: Burden of Patient Dropouts and Patients Lost To Follow-Up
Patient Dropouts / Lost To Follow-Up Implications
In any clinical trial, issues of patient retention, patient dropouts and patients lost to follow-up ( LTFU ) poses a major challenge. Each patient represents a significant amount of time, effort and other resources, so that a high rate of patient dropouts are not only costly but pose a risk to the interpretation and [...]
Addressing Clinical Trial Recruitment and Patient Retention Issues Imposed by HIPAA Step by Step (third of a series)
Patient Retention
Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct and patient retention by imposing significant time and cost burden and by impeding clinical trial recruiting and patient retention,1 which in turn has deterred patient search efforts–locating patients lost-to-follow-up. [...]
Determining Clinial Trial Patient Vital Status
Clinical Trial Patient Vital Status
How does OmniTrace determine the vital status of a clinical trial patient lost to follow-up? What a great question!
Our first efforts are to establish that the clinical trial patient is alive and determine the patient’s current address and phone number. Each search can be quite different, and our research procedures will vary depending on the makeup of the [...]
Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA Step by Step (second of a series)
Clinical Trial Recruitment
Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by imposing significant time and cost burdens, and by impeding clinical trial recruitment and retention,1 which in turn has deterred finding patients lost-to-follow-up (LTFU). This post will serve [...]
Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA Step by Step (first of a series)
Recent reports indicate that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by (a) increasing researchers’ administrative burden; (b) increasing overall trial conduct costs; (c) delaying initial project approval; (d) hampering medical record and registry research, and most critical; (e) impeding clinical trial recruiting [...]
22Aug2008 | admin | 0 comments | Continued
Prevent Lost To Follow-Up With OmniTrace’s Patient Locator Service
Patient Locator
Our OmniTrace patient locator division has located well over five thousand patients who were at one point considered lost to follow-up.
Finding missing people is all we do (well almost). We have located tens of thousands of people including: clinical trial patients, lost friends, military personnel, lost loves, classmates, debtors, dead beat parents, missing heirs, lost family members [...]
Impact Of HIPAA On Clinical Trial Conduct
Clinical Trial Conduct
Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval. The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate. It has greatly impacted the conduct of [...]
Find Patient | Find Patient Fast – Improve Clinical Trial Retention
Patient Find
Patient Recruiters, Principal Investigators and Study Coordinators can greatly improve clinical trial retention and reduce patients lost to follow-up by simply obtaining more contact information when the patient is first recruited into a study. Detailed contact information will allow a search company, such as OmniTrace, many more avenues to find a patient in the event the patient becomes [...]
Efficiency of Clinical Trials Require Effective Recruitment, Retention and Return
Efficiency of Clinical Trials
Conducting clinical trials is becoming increasingly arduous for drug manufactures due to several factors including: (a) heightened food and drug (FDA) regulatory scrutiny based on recent safety concerns; (b) inefficiencies and/or unclear guidance imposed by Health Insurance Portability and Accountability Act (HIPAA) guidelines in the research, design, enrollment and follow-up processes; (c) [...]
Clinical Trial Recruitment | Retention Issues for Manufacturers of Diabetes Agents
Clinical Trial Recruitment | Retention
Anxiety lurks among manufacturers of type 2 diabetes drugs, especially those manufacturers who have drugs in late clinical development.
Recent FDA advisory committee recommendations have created an ongoing debate over whether Investigational diabetes agents should be subject to long-term cardiovascular safety. 1 A firm consensus has not been reached, however, several manufacturers [...]
FDA Patient Safety News- Advice for Patients: Warning on Swallowing Benadryl Topical Gel July 1, 2010
- Recalls and Safety Alerts: Warning on Liver Injury with Propylthiouracil July 1, 2010
- Recalls and Safety Alerts: Using External Infusion Pumps Safely July 1, 2010
- Recalls and Safety Alerts: Medication Guide Required for Vivitrol July 1, 2010
- New Medical Products: New Cellular Immunotherapy for Advanced Prostate Cancer July 1, 2010
