I. HUMAN CLINICAL TRIAL PHASES



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I. HUMAN CLINICAL TRIAL PHASES



PhaseI studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.

Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.

Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.


Упражнение 4

Устный перевод в парах. Студент А зачитывает для перевода текст Inclusion Criteria, студент Б зачитывает текст Exclusion Criteria на стр. ???

TRIAL ELIGIBILITY CRITERIA: COMMON COLD

Inclusion Criteria:

  1. Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy.
  2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and are experiencing self-reported nasal congestion of at least stuffy severity (score = 3 or 4).
  3. Subjects have at least two of the following additional symptoms due to common cold: runny nose, sneezing, sore throat, headache, body achiness, and cough, as deemed by the parent.
  4. Findings from the medical history review and vital signs are within the range of clinical acceptability, as determined by the investigator.
  5. Subject and legally authorized representative are likely to be compliant and complete the study.
  6. Subject's legally authorized representative has signed and dated the informed consent form. Subject has given verbal assent, and has signed and dated the informed assent form.

Упражнение 5

Переведите письменно на русский:

Procedure: High-Resolution Anorectal Manometry

Subjects

A total of 115 volunteers were recruited for the study. All subjects tolerated the procedure without complication. Recruitment was weighted towards parous females, as this is representative of the patient cohort that usually present for assessment of anal sphincter function (10, 11). Parous females were significantly older than non-parous females (P = 0.001). Within the parous group (N=62), 16 had more than two vaginal deliveries, 3 had two or more deliveries requiring instrumental assistance, 6 had two or more deliveries associated with episiotomy, and 4 had two or more deliveries associated with a perineal tear. Quantitative values for each manoeuvre are shown for all females, nulliparous females, parous females and males in table 3.

Equipment

HRAM was performed using a solid-state catheter (UniTip: UniSensor AG, Switzerland), of external diameter 12 F, incorporating 12 microtransducers, each of which measured circumferential pressure by means of a unidirectional pressure sensor embedded within silicone gel. Ten of these sensors were spaced 0.8 cm apart, spanning 7.2 cm. The most proximal microtransducer was located within a non-latex balloon 3.3 cm proximal to these. The most distal sensor (located 2 cm below the most distal of the central 10 sensors) was used as an external reference.

Before every study, the catheter was immersed in tepid water for at least 3 minutes to pre-wet the sensors. Sensors were then zeroed to atmospheric pressure. Data acquisition, online visualization and signal processing were performed using a commercially available manometric system (Solar GI HRM v9.1, Medical Measurement Systems (MMS), Enschede, Netherlands).

Protocol

Each subject was instructed to defaecate if required prior to investigation. No bowel preparation was given. All subjects were studied in the left-lateral position with knees and hips flexed. Prior to catheter insertion, a digital rectal examination was performed and the ability of the subject to understand the commands “squeeze” and “push” were confirmed.

All test manoeuvres were performed in accordance with published guidelines (2). To perform the study, the catheter was inserted into the anorectum with the distal 2 microtransducers visible (the second most distal being located immediately outside of the anal verge). This is important, as if the second most distal sensor is inserted past the anal verge; interpolation of recorded pressures would provide an artificially elongated anal canal length.

Following a 3 minute run-in period for the purposes of familiarisation, manoeuvres were performed in a standard sequence with a 30 second recovery period between each manoeuvre (figure 1): rest - anorectal pressures were measured with the subject relaxed, lying still and not speaking for a period of 1 minute; squeeze - the subject was instructed to squeeze the anal canal as strongly possible for a period of 5 seconds; endurance squeeze - the subject was asked to squeeze the anal canal as strongly as possible for a period of 30 seconds; push (simulated defaecation) - whilst still lying in the left lateral position, the subject was asked to bear down for 5 seconds as if to defecate; cough - the subject was asked to cough forcefully once on 2 occasions. Duration of the familiarisation period and minimum manoeuvre number were determined from a pilot study of 50 volunteers who underwent an extended protocol (5 minute rest period, five 5 sec squeezes, two 30 sec squeezes, two pushes, and two coughs).

For squeeze, push and cough manoeuvres, the first attempt was used as practice, and the second attempt used for analysis. In the unusual event of poor participant compliance, a further attempt was allowed at the practitioner’s discretion.

Data analysis

For each manoeuvre period, the anal canal area was highlighted as an ‘area of interest’ using the e- sleeve box (figure 2). This allowed the software to derive the maximum pressure recorded over this anal length at each point in time (sampling rate 10 Hz). Averages were then calculated automatically over the duration of the manoeuvre. The variables recorded, together with their respective definitions, are shown in table 1.

Упражнение 6

Переведите письменно на русский:



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