The DTC microbiome testing industry needs more regulation.

Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm.

Methodological Comparison of Mapping the Expanded Prostate Cancer Index Composite to EuroQoL-5D-3L Using Cross-Sectional and Longitudinal Data: Secondary Analysis of NRG/RTOG 0415.

Purpose: To compare the predictive ability of mapping algorithms derived using cross-sectional and longitudinal data.

Methods: This methodological assessment used data from a randomized controlled noninferiority trial of patients with low-risk prostate cancer, conducted by NRG Oncology (ClinicalTrials.gov identifier: NCT00331773), which examined the efficacy of conventional schedule versus hypofractionated radiation therapy (three-dimensional conformal external beam radiation therapy/IMRT).

Mapping expanded prostate cancer index composite to EQ5D utilities to inform economic evaluations in prostate cancer: Secondary analysis of NRG/RTOG 0415.

Purpose: The Expanded Prostate Cancer Index Composite (EPIC) is the most commonly used patient reported outcome (PRO) tool in prostate cancer (PC) clinical trials, but health utilities associated with the different health states assessed with this tool are unknown, limiting our ability to perform cost-utility analyses. This study aimed to map EPIC tool to EuroQoL-5D-3L (EQ5D) to generate EQ5D health utilities.

Methods And Materials: This is a secondary analysis of a prospective, randomized non-inferiority clinical trial, conducted between 04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland.

The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs.

A proposed definition of microbiota transplantation for regulatory purposes.

The advent of fecal microbiota transplantation (FMT) and the prospect of other types of microbiota transplants (MT), e.g. vaginal, skin, oral and nasal, are challenging regulatory agencies.

Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation.

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance.

Relationships between antiparkinson medication nonadherence, regimen modifications, and healthcare utilization and expenditures.

Objectives: To examine 1) the effect of prior antiparkinson drug (APD) nonadherence on subsequent APD regimen modifications; and 2) the influence of modifications on healthcare utilization and costs by patients with Parkinson's disease (PD).

Methods: This retrospective cohort study included 7052 PD patients with ≥2 APD prescriptions who initiated a modification of APD regimens in 2007. Modification was assessed as changing from one APD to another and/or adding a new APD to an existing regimen.

Antiparkinson drug adherence and its association with health care utilization and economic outcomes in a Medicare Part D population.

Objectives: We examine the associations of adherence to antiparkinson drugs (APDs) with health care utilization and economic outcomes among patients with Parkinson's disease (PD).

Methods: By using 2006-2007 Medicare administrative data, we examined 7583 beneficiaries with PD who filled two or more APD prescriptions during 19 months (June 1, 2006, to December 31, 2007) in the Part D program. Two adherence measures--duration of therapy (DOT) and medication possession ratio (MPR)--were assessed.

Antiparkinson drug use and adherence in medicare part D beneficiaries with Parkinson's disease.

Background: Antiparkinson drugs (APDs) are the mainstay of managing Parkinson's disease (PD). However, there is paucity of evidence documenting patterns of APD use and examining factors associated with adherence to APDs.

Objectives: Our goal was to provide updated, comprehensive population-based data on APD use and adherence and to examine characteristics associated with adherence behaviors.

Racial/ethnic and age disparities in chemotherapy selection for colorectal cancer.

Objectives: To test the hypotheses that African American patients and older patients with stage IV colorectal cancer were less likely to receive newer chemotherapy agents.

Study Design: Retrospective cohort design.

Methods: Among 5068 Surveillance, Epidemiology, and End Results-Medicare patients diagnosed as having stage IV colorectal cancer between 2000 and 2002, a total of 2466 received chemotherapy and were included in the analysis.

Policy implications of drug importation.

Background: Importation of prescription drugs into the United States has been a major health policy issue for some time. The original objective of personal importation was to allow patients to have access to drugs that were not available to them in the United States either for continuation of therapy begun in another country or when all US Food and Drug Administration (FDA)-approved drug options for their condition had been exhausted. An increasing proportion of personally imported drugs are currently marketed in the United States, but imported drugs are presumably available at a lower cost to the consumer.

Formulary tier placement for commonly prescribed branded drugs: benchmarking and creation of a preferred placement index.

Objectives: To examine the relative preferred placement of commonly dispensed prescription drugs and to assess variations in drug coverage across a convenience sample of 12 health insurance plans.

Study Design: A cross-sectional analysis of the plans focused on all 67 patented brand-name prescription drugs from among the top 200 prescribed drugs in 2004.

Methods: For each plan, we created a preferred placement index representing the percentages of drugs that were positioned on the formulary with preferred placement, defined as tier 2 without restricted access.

Variability and growth in spending for outpatient specialty pharmaceuticals.

Specialty pharmaceuticals are a unique group of drug agents used to treat complex clinical conditions. Many specialty pharmaceuticals are biological in nature and administered through injection or infusion. Tracking spending on these pharmaceuticals is complex, because these products may be processed as either medical or pharmacy claims.

White paper: value of specialty certification in pharmacy.

Objective: To address the value of Board of Pharmaceutical Specialties (BPS) certification, particularly as perceived by different stakeholders (pharmacists, employers, government, and academia), and to draw a parallel between specialization and certification in pharmacy and in medicine.

Data Sources: Electronic databases (Medline, International Pharmaceutical Abstracts, Sociological Abstracts), associations/health care organizations Web sites, outside reports, and clinical pharmacists involved in certification processes.

Study Selection: Studies and reports that addressed the value of specialty certification were selected by the authors.

ISPOR Code of Ethics for Researchers background article--report of the ISPOR Task Force on Code of Ethics for Researchers.

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors.