Applied Clinical Trials-05-01-2010

DATA INTEGRATION : Universal Data Standards - Are We Almost There Yet? Beyond the Final eFrontier When EDC and EHR Converge Also in this issue : How Washington?s Health Reform Impacts Pharma, Efforts to Reach Consensus on ePRO in the EU, An Intimate Look at the Trial Volunteer Experience, Braving the World of Social Media

The questions and uncertainties that surround electronic patient reported outcomes in Europe.

Second World Conference on Research Integrity will establish global guidelines for promoting integrity in clinical research.

Lessons learned along the journey to merge electronic platforms in clinical research and health care.

Contrary to common belief, the development of follow-on drugs, often referred to as me-too drugs, does not begin after a first new drug in a therapeutic category receives market approval. The reality is that sponsors are engaged in drug development races that are intensely competitive where the first drug candidate to receive marketing approval belongs to the sponsor that got to the finish line with a satisfactory submission the fastest.

Updates on pediatric trials, including news from a recent study.

Cover

Pharma will pay new fees and rebates but gain drug utilization and safeguards to innovation.

Integration of EHR-EDC data could chang the way clinical research approaches subject recruitment

Patients share factors that most inform, educate, and motivate clinical trial participants.

Industry news focusing on the people and organizations who work in the clinical trials profession.

A look at the past, present, and future of interoperability across the clinical research spectrum.

Whether companies participate or idly observe community activity, this is a tactic worth considering.

Challenges and opportunities of integrating electronic data capture with electronic health records.

The use of CROs to conduct clinical trials, including data management, has increased over the years and will most likely continue to represent a significant part of many companies' clinical research efforts. Consequently, sponsor companies need to be able to budget the costs of these outsourced studies as effectively as possible. No one is pleased when a sponsor company requests bids for a study, or asks a preferred provider to submit cost estimates and the lowest submitted figures are substantially above the amounts expected by the sponsor company.

Perhaps few issues elicit more interest in clinical trial agreements (clinical grants) than the overhead portion of the contract. Clinical trial agreements typically have three parts: procedures, nonprocedures, and overhead.

ISR Reports' data show the CRO industry is improving service delivery, albeit with room for improvement. Not long ago- perhaps as recent as 2005-this chart would have been reversed, when more service providers were missing expectations than exceeding them.

Institutional overhead remains one of the more contentious areas in clinical grant management. There can be substantial variations in these overhead rates from institution to institution with often times little immediately evident reason for the differences. Institution overhead rates in the United Kingdom seem to reflect that same imprecision.

Clinical grant expenditures represent a major portion of the budget for later phase clinical trials. While the relative cost of conducting a clinical trial in a specific geography is not the sole driver in the decision of where to place study sites, relative costs do play a role.

Drug safety has become a significant issue to many portions of society. High visibility issues like the Vioxx litigation have no doubt increased that salience among the general public. Moreover, with changing demographics, economic trends, and wider numbers of medical applications of prescription drugs, usage of these drugs will only increase, as will the accompanying issue of drug safety.

The financial aspect of standard of care in patient treatment has become a major issue for many companies conducting clinical research. Many industry monitors, self-appointed and otherwise, have highlighted the issue of payments to physicians by pharmaceutical companies, including the fair market payment of clinical grants, as possibly influencing physician behavior. Subjects in later phase clinical research must have the malady being treated in the clinical trial. Consequently, many of the treatments these patients receive would and should be covered by third-party payers, typically government agencies or commercial insurance companies.

It now costs more than $1 billion and takes more than seven years, on average, to conduct clinical trials and win regulatory approval to market a new drug. Not only are development costs high and rising steadily, but also only one out of every six self-originated drugs developed successfully completes clinical testing and obtains marketing approval.