Recently, now as “investigational” word often seen on the net. Introduces clinical trials here.
And clinical trials (clinical study)
Parmaceuticals prescribed medical drugs and OTC drugs can be purchased in pharmacies over-the-counter medicines, pharmaceutical products and is undertaking the approval of the Ministry of health review to its drug efficacy and safety of is first sold.
Collect information on drug testing is investigational. This information will be manifested in the treatment of the future.
Effect and safety of newly developed drugs to explore, so that the test is called clinical trials (clinical study).
※ During clinical trials (clinical study), rather than just pharmaceutical company doctor is led to it.
Development of drugs
Clinical trials is one of the drug development process. Therefore, first touch about the entire drug development process ago the clinical commentary.
0. From deciding what drugs to make exploring the substance considered drug whose effects, beginning.
1. Screening test
Likely drug whose effect from, of substance and sift the less toxic ones work. To develop the narrow component here.
※ Time and huge amounts of money takes development. The important point this screening test and the first field set to forecast the future.
2. Previous non-clinical trials
Interactions in vivo and therapeutic pharmacological test effect compared to the existing components, such as to examine how the components interact, biological to examine the negative impact is how much toxicity and ingredients are absorbed how or excreted, or easy distribution to which parts of the body, or accumulate or affect a child know drug Dynamics exam, do. At this stage, as experiments on animals (rats, dogs, monkeys, etc).
Also, methods of manufacture and formulation “how good do processing components as drug from about late from previous clinical trials or research begins.
3. Clinical trials (clinical study)
Human trials here and in pre-clinical results from greatly divides into three.
-Phase 1 trials （ Phase１ ）: few healthy (health), men use. Examine the excretion and distribution to the amount of drugs, absorption, metabolism, and body may use the patient.
And phase II trials （ Phase２ ）: use a small number of patients. Effect is of course, examine the interaction safety (side effects) and other drugs as well.
And phase III trials （ Phase３ ）: Administration result in many patients, (patient number determines the number of statistically meaningful hundreds place is common). Ensure further safety, effectiveness, etc.
To organize the above test results, the new drug application to the Ministry of health. Has said the takes approval, 1-2 years from the application. Not only clinical trials approval time too long compared to the West because the shortening is challenge this time.
And post-marketing (PMS：Post Marketing Surveillance, Phase４)
Received the approval of the drug, sold after the research. Patients were used is the target all used depending on the characteristics of the drug, patients may target (investigation of all cases).
Participation in clinical trials
There are a lot of opportunities to patients are considered investigational phase III requires clinical trials recruiting top people could test （ Phase３ ）.
Clinical trial recruitment, such as doctors and hospitals clinical trials contact （ because the alias depending on the hospital clinical research center, clinical trials Center, please contact ）, brochures, Internet, and lets you know.
Clinical trial participation is not possible for all people rather by drugs （ accurately test implementation plan (Protocol) by ） depends on the conditions to join.
For example, if a if a heavy degree of disease, liver or kidney function decline, other similar contact there so if you are taking medications such as variety may conditions vary by drug, first got information on clinical trials.
Clear conditions, start clinical description of the clinical trial and ago, sign the agreement. Please properly described, I do not know where questions, confidence to participate in clinical trials.
You can tell now want to decline at the cancel participation in clinical trials at any time to sign the agreement.
Also, tone, or worse, side effects, of course, effects were seen in the medicine in participating in clinical trials to get treatment at doctors discretion cancel.
It is my opinion, benefits to participate in clinical trials, think to treat disease more so take various questionnaire and data treatment in.
I think you’ll have health workers involved in clinical trials, and many took a communication, safe to receive investigational.
Only the data is even, the above drugs. Who drugs everyone is drinking normally, in fact various data becomes the source, rather than just the effect, peace is like a drink. It also takes time and costs are approved by the Ministry and the sufficiency of such data is the difference between so-called supplements and health foods.
As many patients survive medicine taking the data based on the healthcare professionals we also,, I would actively can participate in clinical trials.