A clinical trial is a prospective study that compares the effect, safety, and value of an intervention (e.g., drug or device) against a control in humans. The historical basis for the clinical trial is often attributed to the study of scurvy reported by James Lind, M.D., in his "Treatise on the Scurvy" published in 1753 (Fig. 8.1). Dr. Lind reported on his experiment in 12 sailors with similar cases of scurvy aboard the ship Salisbury. Two sailors each were given a 6-day course of varying treatments, and Dr. Lind reported that the sailors who received two oranges and one lemon per day experienced the most sudden and visible good effects. In fact, he reported that one of them was fit for duty on the sixth day [1, 2].

Clinical trial operations are those activities related to the conduct of clinical trials in the product's development plan (Fig. 8.2). Clinical trials showing efficacy and safety are the central element of a marketing application (e.g., NDA in the United States or common technical document [CTD] in Europe). The conduct of a clinical trial is a complex integration of many activities requiring the coordination of a large number of individuals each with specific expertise. Conducting clinical trials can be further characterized as labor intensive, time consuming, and expensive; it is heavily

Historically, the first recorded clinical trial is that of James Lind, MD in his 1753 publication of "A Treatise on the Scurvy".

Clinical Trial is a prospective study that compares effect, safety, and value of an intervention (e.g., drug or device) against a control in humans.

Fig. 8.1. Background - The Clinical Trial

Clinical trial operations are activities, related to conduct of clinical trials in product's development plan that leads to a marketing application:

o Involves numerous individuals, each with specific expertise c Labor intensive, time consuming, & expensive c Heavily regulated (FDA, HIPAA, OIG, NIH, etc) c Requires clinicians (investigators) & volunteers (patients)

r Drug development is not an exact science:

e It is an effort to bring order & structure to process that is not necessarily orderly. c Demands use of SOPs & integrated management systems

Fig. 8.2. Background - Clinical Trial Activities regulated by several government agencies in the United States and around the world (e.g., FDA, OIG, NIH, EMEA, MHLW); it requires experienced clinicians for investigators and willing volunteers for patients. Furthermore, the information collected will be intensively scrutinized and critiqued by the regulatory authorities in each area of the world and in countries. The marketing application must be approved by the Food and Drug Administration (FDA) or European Agency for Evaluation of Medicines (EMEA) or Ministry of Health, Labor and Welfare (MHLW) in Japan before the product may be made available to the public (see Chapter 7). Therefore, an understanding of the regulations and guidelines related to the conduct of a clinical trial is imperative. Drug development is not an exact science, and the regulations/guidelines do not address every issue that will occur. Developers must bring order and structure to a process that is not necessarily orderly. This order demands use of much structure and many controls in standardized forms, detailed standard operating principles (SOPs), guidelines, and integrated management systems.

► End Goal must be Kept in Mind -NDA Completion & Approval: o Regulatory approval to market new drugs requires demonstration of safety & efficacy.

c Clinical trials are critical to development process;

hence, proper design and conduct of trials are critical. o Clinical trials drive development program.

r Health care systems today demand:

e Evaluation of impact new drug has on cost of patient care o This necessitates that pharmacoeconomic studies are put into clinical development plans r Each day it takes to bring product to market is revenue lost:

p Therefore, planning is critical to entire drug development process, including clinical trial operations.

Fig. 8.3. Background - Goals

As described previously, there are a number of different but interconnected disciplines involved during the development of a new product. Therefore, appropriate planning and effective communication within the project development team is important to ensure quality in an efficient manner. The clinical operations personnel are an important part of the development team, and the clinical trials are critical to the entire development process.

The overall goal in the development of a new product is to provide evidence that the new drug is effective and safe for public use (Fig. 8.3). The NDA is the marketing application that is required to seek authorization from the FDA to market a drug in the United States. The European equivalent of the NDA is a CTD, which is submitted to the EMEA. To complete an application and file it with the FDA or EMEA requires a number of clinical trials that provide the primary evidence for the safety and efficacy of the product (e.g., pivotal trials), as well as a program of supportive studies. Because the clinical trials are rate limiting to the completion of the NDA or CTD, they really drive the development plan. Clinical trials are becoming more complex in patient monitoring, larger in size, and broader in scope, plus they often include studies other than those of just safety and efficacy. Given the cost of health care and the expense of new products, the health care systems and payors of today demand more value from new treatments. Many development programs will include pharmacoeco-nomic studies to evaluate how the new intervention affects the overall cost of patient care. This need demanded by health care systems can add many more trials to the development plan with commensurate increases in costs and time. Often, many clinical trials are required to complete an NDA/CTD. Effective coordination may save years in filing an NDA/CTD. The time of development is important because each day a product is delayed from

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