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7.5.1 Terminology and concepts

7.5.1.1 clinical trial: a scientifically rigorous study of individual outcomes to some process of healthcare intervention. Clinical trials usually involve medical treatments so this document will use the term treatment, rather than the broader term intervention, A clinical trial design may randomly assign and compare one treatment approach with another, or generate safety and efficacy data on a single treatment approach. The clinical trial has a protocol for the patient’s course of treatment and/or evaluation. There is usually a schedule for collection of data to measure compliance, safety, and outcomes.

7.5.1.2 phase of a clinical trial: a treatment and/or observation interval of a clinical trial. A phase may represent an interval with a specific treatment regimen assigned randomly or otherwise, with each regimen of a progression of treatments, or with an evaluation component only. Generally, for each phase, there is an explicit patient management, evaluation, and data collection schedule. Each of these phases may have associated safety, outcome, and quality-control variables. A simpler study design need not use the phase structures.

The phase structure serves several purposes in the clinical trials messages. Other computer systems may need to know that the patient has begun a phase with a particular treatment regimen or diagnostic schedule, such as the pharmacy or order entry systems. When reporting study data, observations and variables often describe particular phase instances. For example, each course of treatment may have its own values for the same set of observations or variables. Phase instances may also have distinct data schedules that need to be linked to submitted data.

Several examples follow with each line depicting a phase.

7.5.1.2.1 Example 1

Alternating treatment plus observation intervals:

   __________>  _________>  _________>  _________>   ...
          Rx A          Rx B        Rx A        Rx B                  

7.5.1.2.2 Example 2

Random assignment to two courses each of treatment A or B, all responding patients to treatment C, continue with observation and a diagnostic regimen after all treatment phases are completed. Treatment phases include the evaluation component for that course of treatment:

     
  ___________> __________     
  Rx A Crs 1   Rx A Crs 2                           
                         > __________>  __________> _______
                         /  Rx C Crs 1   Rx C Crs 2    
  Observe   
  ___________> __________/
  Rx B Crs 1   Rx B Crs 2              

7.5.1.2.3 Example 3

Random assignment to placebo or treatment A, both taken daily and evaluated monthly.

  ___________> __________> __________> __________>  . . . 
    Month 1      Month 2     Month 3     Month 4

7.5.1.3 data schedule: the treatment, diagnostic, and procedural requirements, as well as data collection due dates, scheduled on a timeline for most clinical trials. As data are reported, they may need to reflect the scheduled time point that they satisfy. Clinical trials quality control requires attention to compliance between the protocol’s schedule and patient data records.

The data schedule will be keyed by time points relative to the study. Some data may be due prior to and at the conclusion of the study and/or one or more of its phases. Some are interim within the study or its phases depending on protocol events such as administration of treatment, arbitrary time intervals instated to make and record assessments, or some clinical milestone such as relapse of disease. Often, multiple data parameters are scheduled at the same time point. Several examples follow:

7.5.1.3.1 Schedule for a randomized cancer prevention trial

Treatment 1st - 3rd Years


Reg

Rand

Months




3

6

9

12

18

24

30

36

42

48

54

60

66

72

78

84

Disease Staging

X

















H & P

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Assess Adverse Events and Outcome Variables

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Chest PAL Xray

X



X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

CBC, Diff, Plt

X



X

X

X

X

X

X

X


X


X


X


X

SMA 12

X


X

X

X

X

X

X

X

X


X


X


X


X

Cholesterol and Triglyceride

X


X

X

X

X

X

X

X

X









Electrolytes

X


















Plasma Retinoic Acid

X

X

















Cotinine Level (nonsmokers)


X

















7.5.1.3.2 Schedule for a cancer chemotherapy trial

Prestudy

Prior to Each Cycle

During Cycle

Every 3 Cycles

End Study

Informed Consent

X

X




H & P Neurologic

X1




X

Vital Signs

X1


X2


X

Disease Staging

X

X3



X

ECG

X1


X4



Radiology*


X


X5

X

Chest Xray

X

X



X

Bone Marrow Bx.

X6





HCG

X1





Assess Adverse Events


X



X

CBC, Diff, Plt

X1



X7

X

UA, PT, PTT

X1




X

SMA12, Mg, CEA

X1

X



X

1 Within 3 days prior to start of infusion.

2 At 0,10,30, and 60 minutes after start of drug administration and one-half hour after test drug infusion ends for cycles 1 and 2. For subsequent cycles at 0 and 10 minutes after start of drug administration, and at the end of infusion.

3 Record tumor measurements at the end of every cycle if assessable clinically by physical examination or with simple X-ray.

4 Continuous ECG monitoring during infusion if necessary, due to bradycardia (<50 beats/min) or other significant cardiac findings.

5 When measurable disease requires complex radiologic studies such as CT or radionuclide scans.

6 To be done at baseline (if clinically indicated) at the option of the investigator and also during study if patient has prolonged myelosuppression (WBC<2000 cells/mm3>14 days).

7 Blood counts will be done twice weekly during cycles 1 and 2, then weekly.

* Radionuclide scan and X-ray of the bones, CT scans of the chest, pelvis, and brain only when clinically indicated.

7.5.1.3.3 Schedule for a randomized pain medication trial

Day 1

Before RX

Day 1

After RX

Daily

Day 30

H & P

X



X

Creat, Bili, SGOT

X




Urinalysis

X




Pain Diagnosis

X




Opioid Dose Strand

X

X

X

X

Non-opiod Analgesic


X

X

X

Medications for Side Effects


X

X

X

Phone Report: Pain and Side Effects



X


Visual Analog Scales

X

X

X

X

Pain Evaluation Form

X



X

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