News

The clinical and technical teams use the protocol and a set of specifications as a road map for developing the software and the support structures for an EPD study.

Kimberly Irvine and Eileen Hilton (CenterWatch, Boston, MA, 2003), 158 pages, paperback, ISBN: 1930624395, $39.99.

Planning and preparation, along with imaginative innovations, can put an investigative site on the road to best research practices.

FDA surprises the pharmaceutical industry with its new interpretation of the Electronic Records, Electronic Signatures rule.

Economic realities are changing the way companies do business. One significant change is the growing numbers of freelancers in the clinical trials arena.

John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.

HIPAA?s new Privacy Rule is in effect, and sponsors and clinical research professionals are learning how to apply it.

ACT's 11th annual guide highlights applications, software, Web-based solutions, and more.

For years, EDC providers have claimed that the technology can increase efficiency and potential cost savings. Survey results indicate that clinical monitors agree.

Postmarketing research is conducted differently than preapproval research, but data gained using different standards can be difficult to integrate.

Readers respond to feature article and editorials.

More than 1000 contract research organizations exist worldwide, and the number is growing. CROs differ widely in size and profile. Before a project can be contracted out, sponsors often spend valuable time searching for the CRO that best fits the project's specifications. Consultants are often needed to help hew a path through this jungle, a task made all the more difficult by the intentional withholding of information that would help sponsors decide. The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their companies, and herein I offer a model for CROs to use.

For years, clinical trials have been largely sheltered from the liability lawsuit crisis that has plagued other industries. That is changing.

Recruiting children to participate in clinical drug trials is an activity closely scrutinized by regulators, bioethicists, ethics committees, institutional review boards, and the popular press. The FDA acknowledges the vulnerability of pediatric subjects and has implemented heightened regulatory safeguards. Pediatric clinical trials represent a powerful, emotional platform because of the potential for conflict of interest among a number of parties, including pharmaceutical company sponsors, study investigators, and parents.

As the number and complexity of clinical trials grows-lengthening clinical trial durations and raising costs-sponsors and CROs need a way to streamline trial management, shorten study durations, and reduce expenditures. Customer relationship management (CRM) strategies update the paper-intensive methods of the past and offer an innovative approach to managing clinical trials-an approach that focuses on strengthening relationships between trial participants, especially investigators and subjects.

If it?s not clear who?s in charge, then no one is?and process improvement can be undermined.

Electronic data capture can be invaluable to speed clinical development processes. A recent study demonstrates the reliability of data collected by this method.

Security issues for electronic data capture may seem daunting, but they can become manageable with the right professionals and careful evaluation.

Subject diaries are used in about one-fourth of all clinical trials to collect data on primary and secondary endpoints.1 Part 1 of this four-part series on developing and implementing subject diaries compared and contrasted traditional paper and electronic diaries.2

Like all new technologies, the potential benefits of Linux also carry risk for pharmaceutical developers.

Registered dietitians can be effective study coordinators, as was shown during a hemodialysis study.

A review of clinical trials lawsuit king Alan Milstein's Web site.

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.