Payment for a trial can range from $1-2K to tens of thousands of dollars, depending on the risk of the drug, the cycle time, and the amount of blood collected. To avoid interactions between the first and second drugs, the law requires that you can only participate in a trial once every three months.
At present, the first phase of the health program is broadly divided into the following categories:
1, listed drugs: These drugs are designed to assess the efficacy of two of the same drugs for comparison, the safety of these drugs has generally been confirmed;
2, foreign marketed drugs not listed in the domestic market: These drugs into the Chinese market, the need to confirm the safety of its metabolism in Chinese populations, due to differences in the ethnical differences, so it is necessary to do the relevant safety drugs.
2, foreign listed domestic unlisted drugs: these drugs need to enter the Chinese market to confirm the safety and metabolism in the Chinese population, due to the differences in human race, so the need to do relevant safety drug studies; safety is generally acceptable;
3, innovative drugs: this is a new drug, the safety of which is still being explored, the ability to enter the clinic in the drug; the first in the animal research observation.
It is a drug with three poisons, but the probability of serious side effects is very low. The test drug dose is low, short time, each time only eat a capsule, usually eat 2 times, the interval time of about a week. Each test drug project on the subject of different requirements, generally in the blood draw measurements are in the 150ml or so, there is no effect on the human body, generally donate blood in 200ml-400ml test drug than donate blood draw measurements a lot less medically recognized small amount of blood donation on the human body intentional health!
Each hospital test base is a nationally recognized base, medical equipment and technology are more advanced first-class! In the event of an emergency, first aid measures can be taken quickly! Another thing to emphasize is that the state attaches great importance to the safety of medication, and there are relevant regulations to protect the subjects; hospitals as test implementers, before carrying out the consistency evaluation, will be held in various doctors, experts, community members to participate in the Ethics Committee, only after fully discussed and approved to carry out the test, in other words, all the test is also after strict control. The drugs being tested are not the same, and the level of risk is also different, but the medical institutions will not dare to put the volunteers at risk.
Generally the test medication volunteer is to fill out the information to enroll first, and wait until the hospital calls to notify to go for a physical examination. After the completion of the physical examination and wait for the hospital to notify the results of the physical examination, if qualified can be successfully enrolled in the group (T drug and R drug order randomized, TR group or RT group. Each cycle only take a drug, has been listed on the foreign imports, or domestic generic drugs. (There are also three cycles of the program, TRR, RRT and other grouping trials). Generally will be informed a day in advance to check into the hospital, check-in that will lock up the clothes and bags, can only wear the uniform clothing provided by the laboratory, you can carry cell phones and other personal belongings.
After the medication is administered in the morning, the nurse will collect blood from the test subjects at regular intervals to observe adverse reactions. Some special experiments will use special recording methods, such as subcutaneous injections of drugs will use a camera to record the reaction at the injection site, and contrast agents will use imaging means to observe their changes. In order to ensure that there are no accidents during the drug trial, food and accommodation are arranged, and no take-away food or drinks are allowed. The trial period is indeterminate, although on the last day of discharge, there will be a physical examination to confirm that the subject is healthy and has not been adversely affected by the drug when discharged from the hospital.
The most common damage to the body from prolonged participation in drug trials is to the veins. The most common injuries are to the veins, mainly the median elbow vein, which is often used to bury intravenous needles, and the cephalic vein. Phlebitis is rare, but the venous circulation can easily be altered as a result, such as the vein "not being able to be found", or the vein not being able to give the injection.