News

With the rapid geographical expansion of clinical trials, industry professionals are increasingly willing to set up studies in exotic locations. Although their initial concerns about the quality of data from far-flung studies have dissipated, debate continues about the ethics of performing trials in new locations, especially in developing nations.

Mock inspections can effectively test the preparedness of a site or sponsor-and also train employees to handle a real FDA inspection.

It may seem impossible to do what we know is right?to try to save time and money by spending time and money.

To minimize time to market, sponsors must explore new subject recruitment techniques.

What happens in the six months before a trial is just as important as what happens during the trial.

The interest in exploiting the Internet and its associated technologies to revolutionize the conduct of clinical trials continues to be discussed at length in journals and at conferences.1-4 Although increasing numbers of clinical trials are being commissioned and performed as e-studies, the general take-up is still low when compared with traditional methods. Estimates suggest that approximately 5-10% of all clinical trial data are collected and managed currently as e-trials.5

Six years ago, our department of a large academic research center was having difficulty enrolling enough subjects in osteoporosis studies. We wanted to expand into a variety of trials and increase the number of participants. Despite our experience and expertise, our enrollments were down. We wondered if the pool of eligible participants was shrinking, if our competition was doing a better job than we were, or if we needed to modify our project management style.

New technologies allow prospective subjects to absorb information about a trial at each individual?s pace.

Sometimes a new year requires a new approach

For 2003, as always, each issue of Applied Clinical Trials will contain peer-reviewed articles on aspects of managing GCP-compliant clinical research. In addition, each issue will include articles on a theme of special interest.

Find out how you can reach key decision-makers in every area of the pharmaceutical business...

Academic, certificate, and distance learning programs are available through colleges and universities. Other commercial and professional organizations offer conferences, on-site and customized training, short courses, workshops, and self-study aids.

Some terms have different meanings in various disciplines, but many have become standardized by ICH guidelines.

The consumer press has its spotlight on clinical research again, and some commentators are focusing on subject recruitment.

With 2003 fast approaching, all we know for sure about the EU?s legislative changes is that nothing is final yet.

The reviewer calls the second edition of Stephen Senn?s text ?well structured and easy to read.?

Wherever they live and whatever their area of interest, clinical trials professionals can probably join a group of professional peers.

Abbreviations don?t always mean the same thing to everyone everywhere, but these translations can help make sense of initials commonly used by clinical researchers.

A former White House advisor on health policy, Mark McClellan, is FDA's new commissioner.

Successful recruitment requires a good fit between the subjects, the sites, and the protocol. Here?s how to assess the necessary tailoring of procedures.

A health care attorney clarifies how amendments to the HIPAA Privacy Rule bear on the recruitment of clinical trials subjects.

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

The results of a Web-based survey of some subjects in recent clinical trials suggest ways to improve the consent process.

A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.

Our 10th annual guide to applications highlights software, Web-based solutions, and more.

Paul Bleicher examines the pros and cons of broadband Internet technology and explains how to build a home network and make it secure.

Putting staff training at the bottom of your list of important tasks is a self-defeating attitude in the business world.

Integrating IVRS with in-house clinical trial management solutions can provide a powerful project management tool.