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 market place.
As with Phase II and Phase III studies, patients represent valuable data, therefore retention of patients, so that they are not lost to follow-up (LTFU) is equally important in later phase studies to assure appropriate data collection and dissemination of results.
Is there a difference between Phase IIIb and Phase IV studies?
Yes. Phase IIIb are typically conducted to provide head-to head comparison data, confirmation of earlier results prior to product approval and/or to gain
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 timelines.1 Failure in recruiting and retaining clinical trial patients has the greatest impact on trial costs, delays, and failures. Sites that optimize clinical trial patient recruitment so that patients are retained and not lost to follow-up (LTFU) will be more successful in the long term.2
What procedures can be implemented to recruit clinical trial patients more successfully?
Several clinical trial patient centric approaches can increase success rates. One such approach that has shown success is recruitment web-based systems.3 For potential patients, these systems offer
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 that high dropout rates are not only costly but pose a risk to the interpretation and validity of the intended research findings. Patients not retained, or dropouts of a study can quickly become lost to follow-up (LTFU), a critical situation where it is difficult to locate the patient and necessary patient information.
What affects does poor patient retention have on clinical trials?
Patient dropout and those LTFU after recruitment negatively affects study duration, cost and generalizing the study results, which may result in regulatory approval delay. In fact, it is widely recognized that high dropout and LTFU rates in
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 this article is risk management and the associated value of patients’ participating in clinical research, as they are a major resource to clinical drug development and represent important safety information during the clinical trial period and beyond.
What is pharmacovigilance (PV) and how does it relate to clinical research?
PV is an integrated risk management approach/system developed in efforts to
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 intended research findings. Therefore, retention and adherence processes are critical so patients don’t dropout and become lost to follow-up (LTFU).
Such procedures require a combination of patient, physician, and coordinator related factors including recruiting patients per protocol inclusion criteria, managing patient expectations, and
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 validity of the intended research findings.
Patient dropouts / patients not retained of a study can quickly become lost to follow-up ( LTFU ), a critical situation where it is difficult to locate the patient and necessary patient information. Retention and adherence depend on a combination of patient-, physician- and coordinator-related issues–factors that need to be carefully evaluated to ensure success. Analyzing rates of patient dropouts and when they occur can give important information about
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. This commentary will serve as the third of a series that will discuss strategies to enhance patient retention and finding patients lost to follow-up based on evolving interpretations of the HIPAA regulations.
Challenges of Patient Retention
When conducting a clinical study on a treatment or intervention, it is imperative to retain patients throughout the entire study duration and for a follow-up period, which can be months or even a decade for longitudinal studies. Patient retention for study duration and follow-up represents a
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 clinical trial [e.g., age of patients, economic status of patients, health status of patients, geographic information (urban or rural)].
When conducting a search for an “alive” patient, we are typically flagged by our proprietary databases if the patient has been deceased for more than thirty days–our databases pull directly from the Social Security Death Index (SSDI).
If we are unable to determine a patient’s current address and the SSDI does not indicate that the patient is deceased, we check available state death indexes which often contain vital status information not in the SSDI.
If we are still unable to determine a patient’s vital status, we search
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 as the second of several that will discuss strategies to enhance recruitment, retention, and finding patients lost-to-follow-up based on evolving interpretations of the HIPAA regulations and will focus on initial patient contact.
Contacting eligible participants for clinical trial recruitment is a challenge and HIPAA regulations have made this process more complicated. Pre-HIPAA, patient lists and their contact information were accessible for review, and clinical study personnel were able to
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 and retention,1 which in turn has deterred locating patients lost-to-follow-up (LTFU).
Subsequent to our recent post that focused on these factors that hinder the conduct of clinical trials as a consequence of the HIPAA, this commentary will serve as the first of several that will discuss strategies to enhance recruitment, retention, and finding patients LTFU based on
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 and persons in hiding.
Here are a few reasons why you should consider OmniTrace as your patient locator provider:
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 clinical trials, however, not in a favorable way. The focus of this post is to highlight various factors that have hindered the conduct of clinical trials as a consequence of rules imposed by HIPAA.
HIPAA of 1996 included a major provision that required
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 lost.
We suggest you request the following information when enlisting a new patient for
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) and increased demand and competition for patients due to a plethora of investigational products under study, as well as the increased scope and design of studies.1
An obvious critical determinant of successful clinical trial research and subsequent product approval is to assure full compliance of regulatory/guidelines mandates of governing authorities throughout the entire clinical process. Other key determinants associated with the success and efficiency of clinical trials are recruitment, retention2 and return, especially when
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 are already scurrying to develop plans and design studies addressing impending implications of a
