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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 2

Một điển hình của thử nghiệm lâm sàng hiện nay chi phí những gì lãng phí không gian bắn vào những năm 1950. Chúng tôi không cần phải làm cho những sai lầm tương tự đã được thực hiện trở lại sau đó. Tìm sự khác biệt và tận dụng lợi thế của sự sẵn có ngay lập tức thông tin mà máy tính hỗ trợ nhập dữ liệu cung cấp để cắm các lỗ phát sinh. | A typical set of clinical trials today costs what that wasted space shot did in the 1950s. We needn t make the same mistakes that were made back then. Find the discrepancies and take advantage of the immediate availability of information that computer-assisted data entry provides to plug the holes as they arise. PAY FOR RESULTS NOT INTENTIONS The most expensive single item in any study today is the physician s fee. Well perhaps hospital charges can be appreciable as well. But you don t pay the hospital until after the surgery is completed and the patient discharged. Similarly do not pay the physician or specialty laboratories until all the completed forms are in hand. See sidebar Chapter 14. PLAN DO THEN CHECK Even if you follow every step of the prescription outlined in the next chapter something is bound to go wrong or at least turn out differently from the way you anticipated. A study is never completed until you have reviewed the outcome noted your errors and without assigning blame prepared for the future. You ll find more on this topic in the final chapter of this text. CHAPTER 2 GUIDELINES 13 Part I PLAN We can t solve problems by using the same kind of reasoning we used when we created them. Albert Einstein Chapter 3 Prescription for Success The PURPOSE OF this chapter is to provide you with an outline of our prescription for success in the design and conduct of clinical trials. PLAN A. Predesign Phase Form your design team see Chapter 4 . Your team s first step should be to decide whether the study is actually worth performing and whether you are ready to go forward. Do you have the information you need on dosage toxicity and cross-reactions with other commonly administered drugs Are the details of any necessary surgical procedure s standardized and commonly agreed on Do you know which if any categories of patients should be excluded from the trials Will the market for the drug device bioengi-neered formulation once these patients are excluded still .