Navigating the New 21 CFR 11 Guidelines
March 1st 2004When FDA commenced discussions on the use of electronic records in lieu of paper records in 1991, it embarked upon a six-year consultation exercise culminating in the issuance of the final rule "21 CFR 11,"1 which came into force on 20 August 1997. The final rule itself is succinct (approximately 2000 words), but has given rise to massive amounts of commentary and interpretative text. The latest guidance aims to address issues with these secondary texts rather than the rule itself.
Transforming EDC-The Emerging eR&D Model
February 2nd 2004As so many articles have noted,1 the uptake of electronic data capture (EDC) and associated technologies has continued to be disappointing. Even though 20 years ago experts predicted that electronic case report forms (CRFs) would replace paper as a natural consequence of the introduction of computers, this has not been the case.
Conducting Clinical Trials with Plasma-derived Products
January 1st 2004The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.
Data Warehouses: Your Company's Future in the "Stars"
December 1st 2003Somewhere in a closed conference room, the IT wizards are plotting the data strategy of your company or institution. They are wrestling with the vast amount of raw data that is being collected and the challenges of making that data available as information to help in making decisions.
Guidelines for Obtaining Informed Consent for Clinical Research
November 2nd 2003Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.
A Clinical Development Solution Tailored for Biopharmaceutical Companies
November 1st 2003The 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).
Recruitment Rates and Data Quality -- Are They Linked?
November 1st 2003Clinical 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
Merging Collaboration and Technology: The Virtual Research Organization
October 1st 2003The economic consequences of inefficient work processes in clinical trials are significant. The average daily cost of drug development runs about $30,000 per day and rises by 10% to 12% per year. Development cycle times range from three to 12 years.1 In typical operational practice, the line management of a competitive firm strives to achieve the highest volume of successful new drug application (NDA) submissions (effectiveness) in the shortest practical time (efficiency). This combination reflects the business throughput of an organization.