What Types of Trials Are There?
There are typically two groups of clinical trials: comparative studies and open label studies.
There are inherent differences between the two types of trials, which both evaluate the safety and efficacy of investigational drugs and treatments.
Clinical Trials: Comparative Comparative, or controlled, clinical research studies involve two groups of patients.
One group receives the investigation drug, while the control group receives a placebo, existing treatment or none at all.
Another type of comparative trial is conducted as "double-blind," meaning that neither the patients nor the investigators are aware of which group is the control and which is receiving the drug.
Clinical Trials: Open Label Open label trials are the opposite of comparative trials, meaning that no control group or blind is used.
Therefore, both the investigators and patients are aware of who is receiving the investigational treatment.
Clinical Trials - Phase I-V The four phases of clinical trials comprise the entire drug approval process, which can typically take eight to 10 years to complete.
Every new pharmaceutical drug needs to progress through this entire process before it can be approved for the market.
Phase I Trials The first stage in testing new and innovative drugs for the use in humans is called Phase I clinical research trials.
Phase I trials test the new drugs for toxicity, dosage and safety for use in humans.
Phase I clinical research is conducted on an inpatient basis and can go for a duration of a few months to many years.
Who Participates in Phase I Research? Small groups of participants are used for Phase I clinical research, usually ranging between 20 to 100 human participants.
Participants in Phase I trials typically receive compensation for their time and travel, especially considering the trials are conducted on an inpatient basis.
Phase I research uses healthy, college-aged volunteers.
Though, there are a few rare studies where terminally ill patients are used test very new and/or toxic for HIV, AIDS, cancer and similar diseases as a last resort treatment.
Why is Phase I Research Conducted? Single doses of the investigational drug will be given at the inception of a Phase I clinical research study.
Throughout the duration of the trial, the dosages will be increased and changed while side effects are monitored.
Researchers will also monitor toxicity levels, absorption rates and the distribution pattern of the drug in the human body.
Patients are sequestered during this stage for 24-hour periods to undergo various tests related to the dosage changes.
There are inherent differences between the two types of trials, which both evaluate the safety and efficacy of investigational drugs and treatments.
Clinical Trials: Comparative Comparative, or controlled, clinical research studies involve two groups of patients.
One group receives the investigation drug, while the control group receives a placebo, existing treatment or none at all.
Another type of comparative trial is conducted as "double-blind," meaning that neither the patients nor the investigators are aware of which group is the control and which is receiving the drug.
Clinical Trials: Open Label Open label trials are the opposite of comparative trials, meaning that no control group or blind is used.
Therefore, both the investigators and patients are aware of who is receiving the investigational treatment.
Clinical Trials - Phase I-V The four phases of clinical trials comprise the entire drug approval process, which can typically take eight to 10 years to complete.
Every new pharmaceutical drug needs to progress through this entire process before it can be approved for the market.
Phase I Trials The first stage in testing new and innovative drugs for the use in humans is called Phase I clinical research trials.
Phase I trials test the new drugs for toxicity, dosage and safety for use in humans.
Phase I clinical research is conducted on an inpatient basis and can go for a duration of a few months to many years.
Who Participates in Phase I Research? Small groups of participants are used for Phase I clinical research, usually ranging between 20 to 100 human participants.
Participants in Phase I trials typically receive compensation for their time and travel, especially considering the trials are conducted on an inpatient basis.
Phase I research uses healthy, college-aged volunteers.
Though, there are a few rare studies where terminally ill patients are used test very new and/or toxic for HIV, AIDS, cancer and similar diseases as a last resort treatment.
Why is Phase I Research Conducted? Single doses of the investigational drug will be given at the inception of a Phase I clinical research study.
Throughout the duration of the trial, the dosages will be increased and changed while side effects are monitored.
Researchers will also monitor toxicity levels, absorption rates and the distribution pattern of the drug in the human body.
Patients are sequestered during this stage for 24-hour periods to undergo various tests related to the dosage changes.