**4. Conventional clinical trial design**

A clinical trial is intended to produce credible results answering the questions raised about a drug or treatment without exposing patients to unnecessary risks.

It thus requires rigorous scientific methodology:


A clinical trial is a project which involves different tasks and the final quality of its conclusions depends on the wakest link in the chain of events. Therefore, it is important to make a major effort in ensuring the quality of each area of interest involved, i.e. quality of documents, medical products, monitoring, follow-up of adverse events, and the computerized data processing. In addition, the quality of trial should be "auditable" at all times, and hence the need for quality in archieving all documents [table3].

participating in several international clinical studies –more than one hundred fifty-focused mostly on hypertension and diabetes, but also on lipid disorders and ischemic heart disease; many of them are well recognized everywhere by prestigious publications using acronyms titles for an easier identification of them: SYST-EUR, HYVET, CONVINCE, VALUE, ONTAR‐ GET, TRANSCEND, TECOS, STABILITY, SAVOR, ODISSEY, OMNEON, LIXILAN, as well

Our participation in clinical trials about diabetes represents a big and continual effort in the most relevant clinical research of this important and crucial area. We believe and hope that the abstract's information (clinical and pedagogical) contained in this article will be suitable to many physicians (practitioners, internists, cardiologists, endocrinologists), chemists, nurses and others health professionals. Unfortunately, nowadays the knowledge concerning clinical trials and it relevance for research and health is very poor not only for physicians but also for the general population. We would like that the present book and particularly this chapter will offer some attractive and available information for a better knowledge of diabetes mellitus and

From this particular contribution we present to the reader a conventional design of clinical trials commonly used everywhere. *Sensu lato*, the primary objective is to provide better benefits to diabetic patients by the new non commercialized drugs (phases II, III of clinical trials) matched to ordinary ones or placebo. To reach the aim of this research it is mandatory to have a huge financial support coming from pharmaceutical companies, with the indispensable contribution of investigators, patients, data managers, physicians, auxiliary staff, technical support, computer experts, nurses, etc. In summary, the following twenty items represents a

A clinical trial is intended to produce credible results answering the questions raised about a

**•** In choosing the options in the methodology (study design, protocol, development, calcula‐ tion of sample size, statistical analysis) which are the subject of another work in this

**•** In conducting the trial: this is the objective of the rules of Good Clinical Practice (in research): use of procedures that leave little room for improvisation, validated techniques, suitable working methods, qualified staff, a paper trail documenting all steps, data that can be

A clinical trial is a project which involves different tasks and the final quality of its conclusions depends on the wakest link in the chain of events. Therefore, it is important to make a major effort in ensuring the quality of each area of interest involved, i.e. quality of documents,

schematic example common in many clinical trials in which we participated.

drug or treatment without exposing patients to unnecessary risks.

as other works in process and others scheduled to start in the near future.

current medical challenges.

124 Treatment of Type 2 Diabetes

**4. Conventional clinical trial design**

It thus requires rigorous scientific methodology:

verified post hoc, which are the subject of this book.

collection.



V1: visit 1; V2: visit 2, W-3: week 3; W-2: week 2; FPG: fasting plasma glucose.

#### **Table 3.** Conventional Model of Trial Flowchart



**Screening Run-in Randomization Randomized Post-trial**

**V4…. Day 6**

**V1 V2 V3 Treatment W-3 W-2 Day 1 Phase**

Chemistry panel X X X

Hemoglobin A1c (A1c) X X X

Dispense single-blind X X

Medication compliance X X X

V1: visit 1; V2: visit 2, W-3: week 3; W-2: week 2; FPG: fasting plasma glucose.

1.4. Writing, management and revising procedures

2.2. Protocol\* (standard plan, approved cycle, amendments) 2.3. Case report forms\* (standard pages, approval channel)

Fasting plasma Glucose X X X X

Lipid Panel

Urinalysis X

Placebo medication X

**Table 3.** Conventional Model of Trial Flowchart

1.1. Declaration of principle 1.2. Organization charts 1.3. Definitions of function

1.5. Principles of planning studies

3.1. Submission of project to a committee 3.2. Writing the documents to obtain consent

2.1. Investigator's brochure

2.4. Operations manual 2.5. Study report 3. **PROTECTION OF PERSONS\***

STUDY MEDICATION

126 Treatment of Type 2 Diabetes

1. **PRINCIPLES**

2. **DOCUMENTS**

(FPG)


The procedures for the most part can be written by referring to the following plan.

7.8. Computer systems (validation, documentation, use, security)

7.9. Statistical analysis

8.1. Audit of a study site 8.2. Audit of a study file 8.3. Systems audit

8.4. Preparation for inspection

9.1. List of compulsory test 9.2. Quality control of assays 9.3. Centralized laboratory

10.1. Designing a development plan 10.2. Monitoring a development plan 10.3. Coordination of a multicenter trial

10.5. Termination of a trial

11. **REGULATORY AFFAIRS**

11.4. Insurance\*

12. **MISCELLANEOUS**

11.6. Periodic reports

12.5. Publication 12.6. Abbreviations 12.7. Definitions 12.8. Archieving\*

10.4. Termination of a study center's participation

11.1. Declaration or request for authorization of a trial\*

10.6. Termination of a product development

11.2. Relations with the competent authorities

11.5. Import / export of drugs for clinical trials

11.3. Submission for registration

12.1. Monitoring training programs

12.3. Relations with sub-contractors

12.2. Trial with no direct individual benefit

12.4. Corrective measures in case a document is lost

8. **AUDIT AND INSPECTION**

128 Treatment of Type 2 Diabetes

9. **LABORATORY VALUES**

10. **DEVELOMENT**




