Generic Inclusion & Exclusion Criteria Page

 
  L-MARC Home Page  ::  
   

*** Come back often; this list is routinely updated ***

 

DISCLAIMER: This is a list of common Inclusion & Exclusion study entry criteria derived from different protocols involving different clinical trials of different investigational products at different stages of development. This list does not apply to all studies, and does not represent a recommendation for any specific study.

 

GENERIC INCLUSION & EXCLUSION CHECKLIST

_____ Study subjects must be willing and able to undergo an informed consent process, and voluntarily sign and date an informed consent document approved by an Independent Review Board or Independent Ethics Committee before undergoing any study-related procedures.

_____ Study subjects must meet age (in years) and gender (men and women) criteria of the study protocol.

_____ Study subjects must meet disease criteria as specified by the study protocol.

_____ Study subjects must be willing and able to have the types of diagnostic procedures required by the protocol, such as phlebotomy, various scans (which may be poorly tolerated by claustrophobic patients, etc.), and other testing.

_____ Women must be of non-childbearing potential defined as postmenopausal for at least 2 years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

_____ FOR MOST PHASE III-IV STUDIES: If not menopausal or surgically sterile, then women study subjects must be willing to practice at least one of the following methods of birth control: (1) Total abstinence from sexual intercourse with someone of the opposite sex after a minimum of one complete menstrual cycle; (2) Sexual intercourse with a vasectomized partner; (3) Contraceptive (oral, parenteral, or transdermal) for at least 3 consecutive months prior to investigational product administration; (4) Use of an intrauterine contraceptive device; (5) Other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) for at least one complete menstrual cycle. Men subjects must be willing to practice at least one of the following methods of birth control: (1) Total abstinence from sexual intercourse with someone of the opposite sex; (2) Sexual intercourse with a women not of childbearing potential (defined above) or practicing one of the birth control methods described above; (3) Vasectomy.

_____ FOR MANY PHASE I - II STUDIES: If the woman partner is not menopausal or surgically sterile, then women and men study subjects must be willing to use double barrier birth control methods such as condom or occlusive cap (e.g. diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film, cream, suppository).

_____ Women must have a negative (urine or blood) pregnancy test upon screening laboratory testing, as well as a negative urine pregnancy test the day of randomization.

_____ Study subjects must not have taken excluded drug therapies for a time period (specified by protocol) prior to visit #1 (i.e. day of signing the informed consent document).

_____ Study subjects must be willing to washout applicable drug therapies for the time period specified by the study protocol.

_____ Study subject must be willing to washout applicable non-prescription supplements, which should be limited to only supplements with substantial scientific evidence to support interference of the supplement with the same disease being affected by the investigational product, inherent toxicities with the supplement, or with known, and clinically meaningful potential drug interactions with the investigational product. (A general, single, multivitamin per day should be permitted, unless compelling scientific or medical reasons exist that it be excluded.)

_____ Study subjects for most lipid trials are usually able to continue to take over-the-counter (OTC) and/or supplements at doses that would not be expected to have significant lipid effects, such as niacin <= 200 mg/day, fish oils containing <= 300 mg of EPA and DHA per day (many OTC fish oil preparations have 1000 mg of fish oil concentrate, which contains 300 mg of EPA + DHA). Examples of OTC/supplements that are often excluded upon study entry include the routine daily use of plant stanols/sterols tablets, capsules, mixes, foods, and margarines; routine daily dietary fiber supplements (e.g. greater than 2 teaspoons of Metamucil or other psyllium-containing supplements per day); red yeast rice supplements; and OTC orlistat.

_____ Study subjects must be willing to washout non-prescription supplements at study entry, if they are taking the supplement to treat the same condition as the investigational product, whether or not substantial scientific evidence supports the supplement's efficacy. Among the more common examples would be garlic and soy isoflavone supplements which are sometimes excluded after study entry in lipid trials, unless permitted based upon anticipated future routine use. However, if not specifically taken for lipid-altering purposes (especially if not taken on a routine basis), then even occasional garlic and isoflavones are often permitted in lipid trials.

_____ Study subjects must be willing to notify the staff of any change in their medical health (including surgeries) or change in drug treatments (addition of drugs, stopping of drugs, or change in drug dose) during the course of the trial.

 

GENERIC STUDY EXCLUSION CRITERIA

EXCLUSION CRITERIA BASED ON MEDICAL HISTORY

_____ Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the investigational product, or agents similar to the investigational product.

_____ Study subjects must not have a history of anaphylaxis or anaphylactoid reaction to any prior drug or supplement of any kind.

_____ Study subjects must not have a history of drug or supplement induced hepatitis of any kind.

_____ Study subjects must not report multiple "allergies" (i.e. no more than 3 allergies to drugs, supplements, or foods, inclusive).

_____ Study subjects must not have a history of current or recurrent illness or disease which is similar to a major toxicity or anticipated toxicity of the investigational product.

_____ Study subjects must not have a medical history of a condition, illness, or disease which represents a contraindication to the use of the investigational product or contraindicated to the use of agents similar to the investigational product.

_____ Study subjects must not have a medical history of concurrent drug therapies contraindicated with the use of the investigational product or contraindicated to the use of agents similar to the investigational product. (Need to provide a detailed table.)

_____ Study subjects must not have a medical history of concurrent drug therapies which have the potential for clinically meaningful drug interactions with the investigational product. (Need to provide a detailed table.)

_____ Study subjects must not have a history of current or recurrent illness or disease which is similar to a major toxicity or anticipated toxicity of any of the comparator drugs in the clinical trial.

_____ Study subjects must not have a medical history of a condition, illness, or disease which represents a contraindication to the use of any of the comparator drugs in the clinical trial.

_____ Study subjects must not have a medical history of concurrent drug therapies contraindicated with the use of any of the comparator drugs in the clinical trial. (Need to provide a detailed table.)

_____ Study subjects must not have a medical history of concurrent drug therapies which have the potential for clinically meaningful drug interactions with any of the comparator drugs in the clinical trial. (Need to provide a detailed table.)

_____ Study subjects must not be employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study.

_____ FOR PHASE I AND II STUDIES: Study subjects must not have a history of concurrent drug therapies with narrow therapeutic windows, such as digoxin, many cardiac antidysrhythmic drugs, salicylate, theophylline, many anti-seizure drugs (e.g. phenytoin, carbamazepine, sodium valproate, phenobarbital, etc.) intravenous "mycins", cyclosporine, and lithium.

_____ Study subjects must not have donated blood two months prior to study entry, and must not donate blood after study entry until at least 30 days after the study subject has completed the study.

_____ Study subjects must not have a medical history of concurrent use of systemic corticosteroid drug therapies (e.g. intravenous, subcutaneous, intra-articular). Nasal, inhaled, and topical corticosteroids are permitted.

_____ Study subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial, as well as within 30 days after the anticipated date the subjects would complete the study.

_____ Study subjects must not have a known medical history of clinically significant heart, vascular, hematologic, orthopedic, rheumatologic, muscle, brain, neurologic (e.g. dementia, uncontrolled seizure disorder, etc.) , gastrointestinal (such as chronic hepatitis B or C, malabsorptive intestinal diseases such as uncontrolled crohn's disease, ulcerative colitis, severe irritable bowel syndrome, other significant gastrointestinal diseases that may interfere with study participation and/or results), endocrine, ophthamologic, infectious (e.g. human immunodeficiency virus, tuberculosis, etc.) immunologic, nephrologic, pulmonary (e.g. poorly controlled asthma, poorly controlled chronic obstructive pulmonary disease, dyspnea, etc.), dermatologic, reproductive, psychiatric (e.g. bipolar disorder, schizophrenia, borderline personality disorder, etc.) disorders, or any other conditions that would present unacceptable risk to study subjects, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.

_____ Study subjects must not have a history of depression uncontrolled by non-excluded drug therapy.

_____ Study subjects must not have uncontrolled or unstable type 1 or type 2 diabetes mellitus, for the purposes of the study defined as: (1) hemoglobin A1c of greater than 9.5%, [OR AS PER STUDY PROTOCOL] (2) more than one episode of hypoglycemia within 3 months prior to v #1 (i.e. day of signing the informed consent document), (3) an instance of severe hyper or hypoglycemia requiring hospitalization in the past 3 years, or (4) change in diabetes mellitus therapies (excluding meal-to-meal, routine, self-adjustments of insulin).

_____ Study subjects must not have known laboratory abnormalities prior to visit #1 (i.e. day of signing the informed consent document) which may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.

_____ Study subjects must not have a family history of cardiac sudden death or known prolongation of the QT interval.

_____ Study subjects must not have a history of myocardial infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery, peripheral vascular by-pass, stent placement, pacemaker placement, etc.) within 1 years of v #1 (i.e. day of signing the informed consent document). If study subjects with any form or cardiovascular disease are excluded, then "vascular disease" needs to be defined. For example, if a cardiac or carotid imaging study demonstrated an asymptomatic 30% lesion, would this be exclusionary?

_____ Study subjects must not have an ongoing history of unstable angina, or alterations in treatment of stable angina within 3 months prior to v #1 (i.e. day of signing the informed consent document).

_____ Study subjects must not have an ongoing history of untreated clinically significant ventricular or atrial dysrhythmias, or alterations in treatment of cardiac dysrhythmias within 3 months prior to v #1 (i.e. day of signing the informed consent document).

_____ Study subjects must not have a history of New York Heart Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry out any physical activity without discomfort, symptoms of cardiac insufficiency at rest, if any physical activity is undertaken, discomfort is increased.

_____ Study subjects must not have had a major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or scheduled for a major surgical procedure during the anticipated participation of the study, or scheduled for major surgery within 30 days after the study subject would be anticipated to complete the entirety of the study.

_____ Study subjects must not have a history of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery.

_____ Study subjects must not have a gastric banding procedure adjusted within 30 days before visit #1 (i.e. day of signing the informed consent document), or anticipates having a reasonable chance of having a gastric banding adjustment during the course of the study.

_____ Study subjects must not have a history of greater than, or less than 5% of body weight change compared to 3 months prior to visit #1 (day of signing the informed consent document).

_____ Study subjects must not have started or stopped anti-obesity drug therapies within 3 months prior to visit #1 (day of signing of the informed consent document).

_____ Study subejct must not have started or stopped any routine nutritional weight loss program, or routine high intensity excercise program within 3 months prior to visit #1 (day of signing of the informed consent document). "Routine" is defined as a determined by the investigator to be of sufficient duration or frequency as to affect body weight.

_____ Study subjects must not have a history of ongoing malignancy. If the malignancy is successfully treated, the study subjects must have no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document). Exceptions may include basal carcinoma of the skin and "in situ" cancer of the cervix, provided that both were successfully treated 30 days prior to visit #1 (day of signing of the informed consent document).

_____ Study subjects must not have a history of organ transplant.

_____ Study subjects must not have had a clinically significant illness or injury within 30 days prior to visit #1 (i.e. day of signing the informed consent document).

_____ Study subjects must not have a history of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).

_____ Study subjects must not drink more than 2 units of alcohol per day.  A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45) ml of 80-proof alcohol for mixed drinks.

 

EXCLUSION CRITERIA BASED ON INITIAL STUDY EVALUATION, BUT PRIOR TO RANDOMIZATION HISTORY

_____ Study subjects must have body mass index (BMI) 18.5 kg/m2 to 35 kg/m2. [OR AS PER STUDY PROTOCOL]

_____ Study subjects must not have uncontrolled high blood pressure defined as systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg.

_____ Study subjects must not have bradycardia defined as symptomatic pulse below 50 beats per minute or asymptomatic pulse below 45 beats per minute.

_____ Study subjects must not have tachycardia defined as resting heart rate >= 95 beats per minute.

_____ Study subjects must not have clinically significant electrocardiogram abnormality on or after visit #1 (i.e. day of signing the informed consent document) and prior to randomization, (particularly if the abnormality represents a substantial change from prior electrocardiograms) which may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.

_____ For unapproved investigational products wherein QTc effects are not known, study subjects must not have a QTc interval of greater than 470 (or sometimes 450) msec. If the ECG tracing is of questionable quality, or if prior ECG have demonstrated no history of prolonged QTc, then the ECG may be repeated. 

_____ For approved or unapproved investigational products with no known QTc prolongation effects, study subjects must not have a QTc interval of greater than 470 (or sometimes 500) msec. If the ECG tracing is of questionable quality, or if prior ECG have demonstrated no history of prolonged QTc, then the ECG may be repeated. 

_____ Study subjects must not have clinically meaningful laboratory abnormalities after visit #1 (i.e. day of signing the informed consent document), but prior to randomization, which may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.

_____ Study subjects must not have liver transaminase (alanine aminotransferase = ALT/SGOT; aspartate aminotransferase = AST/SGPT) elevations that are >= 3.0 times the upper limits of normal.

_____ Study subjects must not have total bilirubin above the upper range of normal, unless prior diagnosis and documentation of Gilbert's syndrome. [ANY INCREASE IN TOTAL BILIRUBIN SHOULD BE EXCLUDED IN PHASE I AND II TRIALS, REGARDLESS OF POTENTIAL CAUSE.]

_____ Study subjects must have creatine kinase <= 3 times the upper limits of normal.  If explained by recent trauma or physical activity, then the creatinine kinase can be repeated.

_____ Study subjects must not have thyroid stimulating hormone >= 1.3 times the upper limits of normal.

_____ Study subjects must not have a positive testing result for possible drug abuse (excluding positive testing for permitted medications).

_____ Study subjects must not have positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus. [OR AS PER STUDY PROTOCOL]

_____ Study subjects must not have an estimated creatinine clearance of less than 50 mL/min, as calculated by the study laboratory.

_____ Study subjects must demonstrate 80 - 120 % compliance with investigational product during the lead-in period, before they are eligible to randomize.

 

OTHER EXCLUSION CRITERIA

_____ Study subjects must not be anticipating a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.

_____ Study subjects must not anticipate a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.

_____ Study subjects must not anticipate a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.

_____ Study subjects must not have planned surgery or other medical procedures that might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.

_____ Study subjects must not have planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol.

_____ Study subjects must be willing to change lifestyle health practices, if specified by study protocol.

_____ Study subjects must not be of a genetic ancestry wherein participation in the clinical trial might pose an unacceptable risk.

_____ Study subjects must not be in active litigation regarding malpractice, workman's compensation, or disability claims.

_____ Study subjects must not have received an investigational product or be treated with an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document), with no plans to potentially start any investigational product or be treated with an investigational device within 30 days after the study subject is anticipated to complete the study.

_____ Study subjects must not have a reasonable life-expectancy of less than 2 years.

_____ Study subjects may be excluded for any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.

 

L-MARC HOME PAGE