[...]...Support 14 0 Budgets and Expenditures 14 1 For Further Information 14 1 11 Data Management 14 3 Options 14 3 Flat Files 14 3 Hierarchical Databases 14 5 Network Database Model 14 6 Relational Database Model 14 6 Which Database Model? 14 9 Object-Oriented Databases 15 0 Clients and Servers 15 0 One Size Does Not Fit All 15 1 Combining Multiple Databases 15 1 A Recipe for Disaster 15 2 Transferring Data 15 4 Quality Assurance... Assurance and Security 15 5 Maintaining Patient Confidentiality 15 5 Access to Files 15 5 Maintaining an Audit Trail 15 7 Security 15 7 For Further Information 15 8 12 Are You Ready? 16 1 Pharmaceuticals/Devices 16 1 Software 16 2 Hardware 16 2 Documentation 16 2 Investigators 16 2 External Laboratories 16 3 Review Committees 16 3 Patients 16 3 Regulatory Agency 16 3 Test Phase 16 3 13 Monitoring the Trials 16 5 Roles of the. .. Data 18 0 Roles of the Committees 18 3 Termination and Extension 18 4 Extending the Trials 18 6 Budgets and Expenditures 18 6 For Further Information 18 7 15 Data Analysis 18 9 Report Coverage 18 9 Understanding Data 19 0 Categories 19 0 Metric Data 19 2 Statistical Analysis 19 4 Categorical Data 19 6 Ordinal Data 19 7 Metric Data 19 8 An Example 19 9 Time -to- Event Data 200 Step By Step 203 The Study Population 203 Reporting... the delay Yet the tale of the ever-befuddled Bumbling Pharmaceutical and Device Company told in the chapters that follow is too often the case in all too many clinical studies The high price of pharmaceuticals today masks the costs of ineptitude THINK TRANSNATIONAL Once optimal dose levels and procedures have been established through Phase I and Phase II trials, begin to think on a transnational basis... Enter your data into the computer and keep them there Computerize: • • • • • • Case report forms Laboratory instruments Data storage and retrieval Data analysis Report preparation Submissions Put a PC or computer terminal everywhere data are to be gathered Computer-assisted data entry, that is, electronic data capture at the physician’s workplace (hospital or of ce) and at the time of the patient’s visit... “Class action suit challenges and what kind would do best to Pfizer over the way it conducted avoid it Controlled large-scale cliniclinical trials in Nigeria five years ago.” cal trials are the only way to get the Financial Times, 3 September 20 01 answers you need 1 Angell M (19 96) Science on Trial: The Clash of Medical Evidence and the Law, New York: Norton 4 CHAPTER 1 CUT COSTS AND INCREASE PROFITS CLINICAL. .. less on the repairs My pessimism stems, in part, from my having spent the last twenty-five years as a consultant to drug and device firms As a consultant, I was always called in at the last moment to “fix” the problem The “fix” took months and was generally unsatisfactory, and all hope of profit vanished when the competitor was first to market I worked full time once, too, for a fast-track boss who’d earned... Monitors 16 5 Before the Trials Begin 16 7 Kick-Off Meetings 16 8 Duties During Trial 16 9 Site Visits 16 9 xii CONTENTS Between Visits 17 0 Other Duties 17 3 Maintaining Physician Interest in Lengthy Trials 17 3 14 Managing the Trials 17 5 Recruitment 17 6 Supplies 17 6 Late and Incomplete Forms 17 6 Dropouts and Withdrawals 17 8 Protocol Violations 17 8 Adverse Events 17 9 Quality Control 17 9 Visualize the Data 18 0... function as though we still A Manager’s Guide to the Design and Conduct of Clinical Trials, by Phillip I Good Copyright ©2006 John Wiley & Sons, Inc CHAPTER 1 CUT COSTS AND INCREASE PROFITS 1 had to carve out each letter by hand and cost their companies millions in unnecessary added costs and millions more in lost profits because of the delays And why the delays? So our manager won’t rock the boat, be caught... to ask redundant questions Store and retrieve character data in character form “0” and 1 may have offered space-saving advantages in the ‘60s when a minicomputer might provide only four thousand characters (kilobytes) of memory and tape was used for mass storage, but today with even a personal computer’s memory measured in millions of characters and compact disks holding billions of bits of information, . Expenditures 18 6 For Further Information 18 7 15 Data Analysis 18 9 Report Coverage 18 9 Understanding Data 19 0 Categories 19 0 Metric Data 19 2 Statistical Analysis 19 4 Categorical Data 19 6 Ordinal Data 19 7 Metric.