Open Payments and the US Clinical Landscape.

Background: The Open Payments database represents a new, substantial source of information on the US clinical trial investigator landscape.

Methods: This paper draws upon the Open Payments database. This database, mandated by the US Sunshine Act, does help provide a vital missing element in understanding the commercial clinical trial landscape in the United States: comprehensive, detailed, clinical investigator and site information by specific clinical trial.

Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion Times.

Background: The pharmaceutical industry has continued to experience a large number of mergers, often involving the very largest companies. Behind many of these mergers has been the desire to achieve scale efficiencies and improved performance in both commercial and research and development (R&D) activities.

Methods: This research draws upon ClinicalTrials.

Are Phase 3 Clinical Trials Really Becoming More Complex?

Background: This study uses the data from many of the mandatory fields in ClinicalTrials.gov to examine changes, possibly leading to more complexity in the design and execution of commercially sponsored phase 3 clinical trials.

Methods: In this analysis we compare baseline year 2008 data, when a broad number of the protocol/study design and execution variables became mandatory, with the data from the last full year of results, 2013.

ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials.

Since 2007, the US federal government has required that organizations sponsoring clinical trials with a least one site in the United States submit information on these clinical trials to an existing database: ClinicalTrials.gov . Over time, the number of mandatory variables has grown and will probably continue to grow.

Managing clinical grant costs.

The rapidly increasing cost of pharmaceutical R&D presents a major challenge for the industry. This paper examines one aspect of that spending, clinical grants, and presents ways that pharmaceutical companies can best manage those expenditures. The first part of the paper examines the role of clinical grant payments as a motivation for clinical trial participation.

The profile of the one-time 1572 investigator.

The FDA database on investigators completing the 1572 form constitutes a rich database of practicing investigators. Within the most recent three-year period, roughly half of all the principal investigators appear only once in the 1572 database, which leads some to conclude that many of these investigators have only conducted one study and may be reluctant to be involved in a second clinical trial. Part of the misunderstanding about these investigators comes from the incorrect notion that 1572 forms are required to be submitted to the FDA.

Do clinical grant payment practices in phase 3 clinical trials influence subsequent clinical investigator prescribing behavior?

The advancement of science requires the cooperation of clinical investigators. Recent discourse, which attempts to relate pharmaceutical company grant payments to clinical investigators to subsequent preferential prescribing behavior, erodes the physician/patient relationship and may lead to an inadequate number of investigators. This study was designed to determine why the level of grant payments to Phase 3 clinical investigators differs for comparable levels of work and whether these differences are related to subsequent prescribing behavior of either the study drug or other drugs from the same sponsoring company.