News

Modern radiological techniques and digital analysis technologies permit rapid evaluation of the efficacy of oncology drugs. Continual review of methods detects flaws promptly, creating the opportunity to take corrective steps.

A set of trials carried out by the Collaborative Ocular Melanoma Study Group at eye centers throughout the United States and Canada led to improvements in the care of patients with choroidal melanoma.

Experts discuss the use of subject diaries and the way researchers can comply with applicable regulations and guidelines.

The European Organisation for Research and Treatment of Cancer is dedicated to improving cancer treatment in Europe. Its Regulatory Affairs Unit provides important services to researchers.

Adaptive interim analysis may allow smaller sample sizes when a drug?s clinical effect is unknown.

Readers like Lynn Sadowski, a senior clinical research associate at Sention Inc., share their experiences.

After years of pilot trials, the pharmaceutical industry still sees EDC as something new. Here are two approaches toward making EDC into business as usual.

Support can be key to a successful EDC clinical trial. These suggestions may help your organization achieve a better experience with EDC.

Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.

Everybody wants faster cycles and and quicker turnarounds with NDAs. In the U.S., will it soon be possible to go from testing to approval in 1000 days?

Studies show that electronic diaries get better results than paper diaries. These authors explain why.

Successful pediatric research requires partnership between the pharmaceutical industry, investigators, ethics committees, and parents.

Readers respond to articles and editorials.

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

In Japan, pediatric clinical trials face obstacles, but new regulations give manufacturers incentive to conduct them.

At work and play, he?s devoted to children.

The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?

European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.

To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.

The authors contrast two views on the regulations concerning electronic source data.

An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.

Readers respond to articles and editorials.

As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.

In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.

The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.

In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.

Readers respond to articles and editorials.

Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.