Feature Article

The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).

Clinical trials sponsors seek quick subject enrollment and high data quality, expressed by both strict adherence to good clinical practice (GCP) requirements and completeness and correctness of the data collected from investigative sites. However, the most informative sources of detailed information on data quality such as site monitoring visit reports, sponsor, and CRO audit reports are maintained as strictly confidential documents and are not publicly disseminated. Therefore, a substantial proportion of the information on data quality in clinical research that is available to the general public is based on anecdotal reports rather than well-referenced and organized observations. The U.S. Food and Drug Administration found no evidence of poor GCP compliance during inspections in the emerging clinical research countries, including Eastern Europe and the former Soviet Union.1-2

Earlier this year, Applied Clinical Trials published "Clinical Monitoring: Answers to Questions about Good Clinical Practice," another excerpt from the book, Good Clinical Practice: A Question & Answer Reference Guide. Readers are referred to the July 2003 issue (pages 27-29) to read the full text of the reference guide introduction.

Interactive voice response systems are commonly used in clinical trials to manage the flow of trial medication supplies to sites and to manage the allocation of these supplies to individual subjects. Other advantages and uses include access to real-time information for trial managers, collection of diary card data directly from subjects, and as an aid to subject recruitment.1

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.

It is increasingly important for clinical trial personnel to break through the obstacles that language and culture present when conducting trials away from their home countries.

Restrictive regulations and cultural differences make regulatory approval in Japan elusive, but adopting new strategies may make that lucrative pharmaceutical market more accessible to non-Japanese companies.

Now that FDA is enforcing its Electronic Records, Electronic Signatures rule many pharmaceutical companies are reconsidering their data systems.

A newly published reference guide answers a wide variety of GCP questions.

CRAs now have to monitor sites? compliance with FDA?s Electronic Record, Electronic Signatures regulation.

John Vogel, clinical researcher turned consultant, is passionate about outsourcing. He believes that pharmaceutical companies can gain competitive advantages through drug development outsourcing.

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

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

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

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.

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

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

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.

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.

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

Sometimes a new year requires a new approach

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.