Research for the Real World

September 1, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-09-01-2006, Volume 0, Issue 0

A discussion of the recent initiatives for applying advanced technologies in real world settings that have the capability to improve drug research, increase subject safety, and reduce development costs, which takes into account the collaborative efforts among government, academia, industry, and patient groups that are necessary to achieve these goals and translate new technological discoveries into clinical practice.

On Wednesday, March 15, 2006, the media broadcasted that "two men were critically ill in a British hospital and four others serious in intensive care after suffering violent reactions to a new drug they took as part of a clinical trial." The Medicines and Healthcare Products Regulatory Agency (MHRA) announced that eight healthy men took part in the trial. Two of the men were given a placebo and six were given the drug. All six participants became seriously ill due to an adverse reaction to the drug.

Pendar Farahani

This was the Phase I of a clinical trial for a drug known as TGN 1412, which is a monoclonal antibody and was intended for rheumatoid arthritis and leukemia patients. Without any doubt, this Phase I clinical trial was conducted under the current regulations and undertook rigorous and comprehensive safety measures, with scrupulously designed procedures and carefully monitored processes. Nevertheless, this incident once again calls for an imminent need to improve the drug development process and should remind everyone of the crucial roles of "Critical Path" (CP) and "Roadmap" initiatives.

In recent years, the Food and Drug Administration (FDA) through the Critical Path1 initiative and the National Institutes of Health (NIH) through the Roadmap2 initiatives have identified various technologies and discoveries to integrate into the therapeutic development process. The implementation of these initiatives can potentially improve the effectiveness and safety of therapeutics, and can also increase the efficiency of the clinical trial process by reducing the costs and time frames of trials.

Explosion of scientific breakthroughs

Scientific and technological evolution has spectacularly accelerated during the last quarter-century, causing an information explosion and breakthrough of discoveries. A vast amount of investment and research has been devoted to advanced technologies related to the health science field, which has led to new discoveries such as biomarkers, pharmacogenomics, gene therapies, cell therapies, and genomics. What is unfortunate, however, is that the application or integration of these technologies into the therapeutic development process has been very limited. Recently, CP and Roadmap initiatives have proposed several frameworks and platforms to facilitate the uptake of advanced technology into discovery methods and the clinical trial process. This way, valuable initiatives may optimize the introduction of more effective and safer novel therapeutics.

Even though the CP and Roadmap initiatives have been proposed in recent years, they have generated a tremendous stimulation among researchers, clinicians, and scientists, as well as biomedical and biopharmaceutical industries. However, collaborative and harmonized efforts among government, academia, industry, and patient groups at the national and even international levels are fundamental components for pursuing the objectives of CP and Roadmap initiatives. In addition, the FDA and NIH have identified other challenging frontiers that must be addressed prior to employing the CP and Roadmap.

Furthermore, the relevance of these initiatives is not limited only to the stages of the medical product development process. These initiatives can also signify the continuous application of various technologies for a wide spectrum of postmarketing purposes, which is especially vital for health care delivery in the population level. In fact, there is growing attention to incorporating advanced technology into the "real world" and translating discoveries into clinical practice. Health care providers can utilize the "new therapeutic technology" for better patient care. These proposals have defined policies and frameworks that may also be extrapolated to the community-based clinical application of technologies for integrating molecular findings into a population.

In conclusion, the implementation of the FDA CP and NIH Roadmap initiatives, which are currently emerging, will enlarge the capability of scientists, researchers, and clinicians to improve the safety and effectiveness of therapeutics and to deliver better health care to the patient population.

Pendar Farahani, MD, MSc, St. Joseph's Healthcare, McMaster University




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