Feature Article

Good organization and technological support are needed to bring the benefits of electronic data capture to a clinical trial.

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.

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

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.

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

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.

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.

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.

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.

Technology can do only so much; understanding human behavior and psychology is the key to improving your communication skills.

Clinical trial samples can be dangerous or infectious. With regulators and airlines cracking down, you should know the rules for their transfer and transport.

Tremendous changes in the capabilities of EDC technology and the capacity of EDC vendors make electronic data capture a reliable tool for significant business advantage.

Whether formally accrediting IRBs will benefit research subjects?or simply create more paperwork?remains to be seen.

Addressing the unnacceptable lack of pediatric labeling requires not only economic incentives but also an understanding of the unique difficulties involved in pediatric studies.

Mutual understanding of roles and responsibilities across the boundary between IT and clinical operations allows both departments to function more effectively.

Investigators are sometimes eager to open a subject?s blinding code when they perceive a medical emergency. Informing investigators about expected adverse events can forestall these requests.

Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.