Trial Medicine – Overview
Trial Medicine is nothing but a synonym of Clinical Trial. It is a process to determine the efficacy of medicines.
The trial Medicine process is performed by a team of Biomedical Scientists and Professional Doctors to determine the outcomes of new medicines and treatments.
The process also involves continuous monitoring of the patients that are receiving the treatments of the new drugs.
The studies collect the effects of a particular drug for curing both types of diseases, known and unknown.
Who performs Medicine Trials?
Medicine Trials are performed by healthcare professionals and scientists under the government’s health agency.
The clinical trials of medicines are performed on a large number of volunteers. Different Government Health Agencies can conduct research or we can say a clinical trial of new drugs.
Types of Government Health Agencies for Clinical Trials
The following government health agencies can conduct clinical trials of new medicines.
- National Institutes of Health
- Doctors of Medical Institutes
- Private Industries with Volunteers
- Independent Researchers
Who gets the Medicine Trials?
Medicine Trials are performed on volunteers. Generally, volunteers are recruited by Government agencies. However, in some cases, Volunteers get paid for the clinical trials by the same agencies.
Medicine Trials require continuous trials on a large number of volunteers.
For that reason, the agencies are always looking for volunteers who allow the clinical trials on their bodies. Clinical trials involve professional doctors from government health agencies.
Depending on the research subjects and the size of the research projects, the volunteers get paid. Some research programs are performed in local communities that pay nothing to the volunteers.
This type of trial medicine is less harmful which means there is a fewer risk associated and for that reason, volunteers don’t get anything from the trials.
How Trial Medicines Gets an Approval?
Trial Medicines reports need to be submitted by the Government Agencies to the Food and Drug Administration Department i.e. the FDA Department.
Based on the report and the outcomes of the treatments, the Government Agency can approve or disapprove the treatment or the medicines that are used for the clinical trials on volunteers.
Since Government Agencies are involved, they have to check the pros and cons of the new medicines. The side effects are also monitored by the agencies
Every drug has its side effects. The clinical trials of new drugs by the Government Agencies conduct long-term trials on a particular drug that determines the side effects of the drug for long-term use.
They also generate reports on experimental drugs, regular drugs, and the drugs that are being given to the volunteers for a particular clinical trial program.
How do government agencies acquire Volunteers?
Volunteers are the backbone for Trial Medicine. Without volunteers, the clinical trials of new medicines would not be conducted. There will be no improvement in the healthcare industry.
Some patients believe that new treatments would cure their diseases faster. They are given all the information about the new treatments and the drugs and the side effects associated with them.
After they agree, the agency will ask them to fill up the application form and that’s how they acquire volunteers for their new drug trials.
Besides this, patients suffering from incurable diseases such as Cancer and AIDS are also asked to join the clinical trial program by the Government Agency.
Patients with incurable diseases hope to get effective therapies from the new treatments and that’s how the list of volunteers keeps on increasing.
What are the Outcomes of Trial Medicines?
If we talk about the possible outcomes from trial medicines, then the outcomes can be categorized into four different categories.
For your convenience, we have enlisted all the possible outcomes here:
- Positive: If the result of the trial medicines is more effective than the present drugs or treatments, then the outcome for this particular trial medicine is Positive. The chances of getting FDA approval for these types of medicines and treatments are high as they show positive data with fewer side effects associated.
- Non-inferior: If the result of the new trial medicines matches with the standard treatment and efficacy, then the outcome is non-inferior.
- In-conclusive: This outcome represents that the drugs or the treatment performed by the medical professionals have neither a positive outcome nor a non-inferior outcome. This type of trial receives mixed results from the volunteers.
- Negative: Negative outcomes mean the current medicines or the treatment is less effective than the standard treatments.
Trial Medicines involve a lot of factors including the risks and the benefits associated with the new drugs and treatments.
If the list of benefits is much higher than the list of risks, then the researchers would first research how they can reduce the risk factors associated with the new drugs or treatments.
As noted above, the trial medicines can have four outcomes. If the phase gets positive results, then the treatments will be ready for public use shortly.
If the agency is asked to perform further tests, then the approval may take several weeks more! Medicine Trials are ongoing processes so there will be mixed reviews from the agencies.