Clinical research project

Green JA. The EDC value proposition to the pharmaceutical industry. A detailed comparison of EDC versus paper model costs for four different clinical research projects (Phase I-IIIb). Datatrak International, Inc., 2001. 

Large CROs can be used for effective planning of large clinical research projects. They commonly have extensive experience in the disease areas to be studied, although they... 

Dunbar, C., L. Chang, C. Mullen, et al.. Amendment to Clinical Research Project. Project 90-C-195. April 1,1993. Treatment of severe combined immunodeficiency disease (SCID) due to adenosine deaminase deficiency with autologous lymphocytes transduced with a human ADA gene. Hum Gene Ther, 1999.10(3) 477-88. 

The objective is the essence of a protocol. It should state explicitly the purpose of the clinical research project. One short statement should describe the type of... 

Develop medication use evaluation criteria and other quality improvement measures to assess the use of drug therapy by other providers. Design, conduct, and coordinate clinical research projects under FDA guidelines and procedures of the institutional review board. 

The objective is the essence of a protocol. It should state explicitly the purpose of the clinical research project. One short statement should describe the type of trial (i.e., open, double-blind, crossover) and why the trial is being conducted. In addition, a brief description of the medications to be used, the indication ) for effectiveness, and the type of subject population to be evaluated should be included. The objective should be stated succinctly, as in the following example The objective of this controlled, double-blind, parallel trial is to evaluate the efficacy and safety of medication X versus medication Y in (diagnosis of disease) as found in an outpatient (or other) population. In one simple statement, the purpose of the trial, the controls, the diagnosis of the subject population, and the setting where these subjects will be observed have been presented. Objectives should reflect the phase or type of clinical research that will be conducted. 

Even after a new drug has been approved and introduced to the market, clinical R D may continue. Some of this postapproval clinical evaluation is required by regulatory agencies as a condition of approval, but other clinical research projects are designed to expand the market for the drug. For example, much clinical research is done to test new therapeutic uses for a drug already on the market or to compare its effectiveness with that of a competing product. 

Some join the industry for only a short period, and then decide that they would prefer to return to their original clinical callings. This, too, can be of professional benefit. One s clinical skills do not decline much in the first 2 or 3 years away from patients, and they can, in any case, be maintained with part-time or locum tenens clinical employment while one holds a position in a pharmaceutical company. Upon leaving industry, it is likely that the physician will take back to the clinic some new skills, e.g. better management techniques and how to approach clinical data with scientific scepticism this experience is not usually available in the ordinary clinical situation. Such a physician will also have inside knowledge of how to increase the probability of industrial sponsorship of his/her clinical research project One author of this chapter, when approached by a doctor with trepidation or vacillating on whether to accept an industry position, has a standard response Now is not make-your-mind-up time. That will be in 2 or 3 years because then you must probably decide whether to stay in the industry . 

Miller WR, Zweben A, DiClemente CC, et al Motivational Enhancement Therapy Manual A Clinical Research Guide for Therapists Treating Individuals With Alcohol Abuse and Dependence. Project MATCH Monograph Series, Vol 2 (NIH Publ No 94—3723). Rockville, MD, National Institute on Alcohol Abuse and Alcoholism, 1995b... 

In a tiny fraction of cases, a quick formula can be used. For most cases, the analysis uses an options tree, with one leaf per possible outcome. However, this falls prey to the curse of dimensionality —the number of leaves on the tree grows exponentially in the number of risk and decision dimensions considered. Thus only a limited, simple set of situations can be optimized in this way because one has to severely limit the decisions and risks that are considered. Tools available to help automate and simplify options analysis, widely used in pharmaceutical project evaluation, include Excel addons such as R1SK [11] and more graphically based solutions such as DPL [12]. Both of these support the creation and evaluation of decision trees and of influence diagrams Figure 11.2 shows a simple example of each of these. A primer in applied decision theory is Clemen s book Making Hard Decisions, other sources may be found in the website of James Vornov, Director of Clinical Research at Guildford Pharmaceuticals, a recent convert to decision theory for options analysis [13]. 

Based on their corporate experience in supporting their own research and development projects as well as a number of government-sponsored activities, the development of scientific software at BBN grew out of a long history of support of a variety of scientific applications. For example, in the 1960 s, BBN developed a hospital information system for Massachusetts General Hospital which used an early minicomputer, the PDP-1, to support clinical research activities. Under the sponsorship of the National Institutes of Health, they developed a system called PROPHET (1) which provides a... 

Kadden, R., Carroll, K., Donovan, D., Cooney, N., Monti, P., Abrams, D., Litt, M., Hester, R. (1999). Cognitive-behavioral coping skills therapy manual A clinical research guide for therapists treating individuals with alcohol abuse and dependence. In M. E. Mattson (Ed.), Project MATCH Monograph Series, 4. Bethesda, MD National Institute on Alcohol Abuse and Alcoholism. 

Considering the risk of modern clinical research and development of new therapeutic entities, sponsors frequently look to CROs to provide increased capacity for projects that need significant additional manpower. However, capacity issues are also a major concern for CROs, as they must juggle resources for new contracts, cancelled programs, frequently unpredictable rates of patient enrollment, and unexpected regulatory holds. The interaction... 

During the conduct of the trial, constant communication between sponsor, vendor, inveshgator and investigahon teams is critical. There is real value in this process, particularly if all parties uhlize a Clinical Trial Management Software System (CTMS) that coordinates all trial activities involving the Clinical Research Coordinator (CRC) at the site and the project managers at the sponsor and CRO locations. 

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