FAQ’s – Learn more volunteering for medical trials and medical research.
Your Clinical Study Infomation Resource
1) Q: What is a Non Invasive Medical Research?
A: Non Invasive Medical Research means there are no invasive procedures involved . That means no drugs to be internalized or needles etc . A typical non invasive research study would include cognitive tests for motor function or psychology pen and paper tests.
2) Q: What is a Phase 1 Medical Trial?
A: This is where medications are being tested for the first time in people after many years of pre-clinical research . This research is usually performed on animals and also very stringent laboratory tests to insure the maximum safety of healthy research participants . There are no health benefits to participating in healthy volunteer medical trials and consequently the reason for your payment for time and inconveniences incurred . There is always the knowledge and greater purpose that in some way you have aided towards reducing the suffering of less fortunate people . The risks involved with Phase 1 Medical Trials can be likened to crossing the street . You could get hit by a bus although its unlikely , but there are things you can do to prepare yourself for medical trials to further insure your ultimate safety .
3) Q: What is a Phase 2 Clinical Trial?
A: This is where a small number of patient volunteers are enrolled onto studies after it has been established that the medications are tolerable in humans and can now be passed onto patient volunteers to see if any likely benefits are apparent for the patient population concerned . This usually involves a very small number of patients .
4) Q: What is a Phase 3 Drug Trial ?
A: This is where a very large number of patients are used to assert improvements in lifestyle in a broader selection of people . Usually trials that make it to Phase 3 Testing will be approved by the authorities for the marketing of the new drug . Once that trial is finished you will be able to try another similar drug you have tested.
5) Q: What is a Phase 4 Medical Trial?
A: These can be conducted through general practitioners or professional testing centers . The drugs are already approved by the authorities but make be looking at different applications or whether or not the drug is better administered in powder form as opposed to tablet form . Generally speaking Phase 4 Trials are the safest of any medical testing as so much more is known about the medications.
6) Q: What sort of drugs do they test on healthy people, and why?
A: Every drug, in any form, whether prescription or over-the-counter, has to be approved by a government regulatory agency before it can be made available. In order for a drug to be approved, it must be deemed both safe and effective. The drug is first tested in laboratory animals (example: rats, guinea pigs) to determine if it is safe enough to be tested in humans.
If safety is determined to an acceptable degree, then trials with humans are conducted using very low dosages of the drug. This is necessary to obtain specific information about the drug, for instance, the rate at which it is absorbed, metabolized, and passed out of the body, how it affects blood pressure, heart rate, etc. and what dosage can be given to subjects before they begin to experience minor side effects such as headache, sleepiness, or dizziness. Many such trials do not involve “experimental” drugs. Instead, they test medications which are identical to or very similar to those already approved and available on the market. This is necessary to learn how a marketed drug compares to a newly developed generic equivalent, to learn how two marketed drugs interact when taken together, or to investigate new formulations of a marketed drug in an effort to improve it.
The first phase of human testing usually involves healthy people who act as control subjects. This is necessary to learn how a drug reacts in a healthy person as compared to a sick person for whom the drug is intended. Healthy volunteers are paid for their time as an incentive for them to participate, since there is no expectation that they will benefit from taking the drug.
7) Q: Aren’t these trials considered risky or even dangerous?
A: Not all medical trials contain an element of risk , But where regulatory oversight exists to safeguard the treatment of research subjects, and where drug companies and testing clinics can be held liable for injuries which may occur , they are very careful to keep all risks to an absolute minimum .
It is true that until the late 1970’s, taking part in such trials contained larger risk because researchers were not obligated to provide accurate information about the drug being administered. In addition, the subject population consisted mainly of prisoners who took part in trials in order to gain early release, and conscientious objectors in the military who wanted to avoid combat duty. As such, participation in trials was motivated by coercion, and thus subjects were not necessarily “volunteering” of their own free will.
In the late 1970’s and the 1980’s, research involving human subjects in most developed nations came under scrutiny. Protective legislation was enacted as a result, and ethical guidelines were established to ensure the professional conduct of researchers. Subjects began to be recruited from the general population and to be paid for their services