What You Should Know First About Testing for Drugs before Undergoing It
It takes a long but sure process to discover, make, and use the new drugs on humans. The first process when a drug is manufactured is to test it using computer models and human stem cells grown in the laboratory. The drug is then used on lab animals to check the risk of toxicity if any. After the animal trials are successful, a clinical trial is done, now on humans. The clinical trial is done to see if the drug can be allowed for a wider range of use. Volunteers or people used for clinical trials should have knowledge about the procedure and how it affects their wellbeing.
If you are considering volunteering for clinical trials, below are some things you should seek to know first before undergoing the process. Before that, however, we will briefly discuss the most popular kind of drug testing.
About Drug Tests
The most popular kind of drug testing is where one is tested for the presence of drugs in their system, perhaps for the purpose of work. It is common among athletes, employees, and patients in health facilities and rehabs. In most of these tests, a sample of your urine, blood, or saliva is taken and tested for the specific drug substance. If you visit this site called DTC, you will familiarize yourself with some of the most commonly tested drug substances. These range from MDMA to alcohol, Fentanyl, THC, MET, and BZO, among others. The best thing is that these test kits are widely available online at affordable prices. This means that you can test yourself even from home and make any necessary adjustments before the actual test.
Who Can Participate In Clinical Trials?
Now, drug trials are done on a wide range of people of different gender, races, ethnicity, and ages. This is because a drug can react differently to different people. When participating in the process, your age, sex, stage of the disease, treatment history, and specific medical conditions (if any) are of great interest. Various trials require different types of participants, but some may only be limited to people with the particular illness for which the drug is being developed. All these factors should help a person determine if they are eligible participants or not. It helps the researchers too to determine the right participants for that particular clinical trial to avoid any form of mistakes that could endanger the lives of participants.
Understanding the Risks
Some drugs being studied can have negative and severe side effects, some of which are temporary, and others may be permanent. Temporary side effects can stop once the treatment stops. Some appear during the treatment, while others show up after. The risks largely depend on the treatment under study and the overall health of the participants. All the risks must be clearly made known to participants before the trial begins. If any other risk comes up during the trial the participants should be informed immediately.
What Happens In The Trial?
Clinical trials are often done by nurses, doctors, and other health professionals in hospitals and research institutions. They first check the person’s health to ensure they qualify to be a participant in the trial. The eligible participants are issued with certain instructions and later monitored and closely assessed during and post the trial. The trial then undergoes different phases.
- Phase 1: Acute side effects are identified, documentation of how the drug is metabolized and excreted is done, and dosing is determined. A few of the healthy participants are used at this phase.
- Phase 2: More participants with the condition or disease that the drug could treat are used. In phase II of clinical trials, researchers aim at finding further safety information and clear evidence that the drug is beneficial. They also develop and refine methods for future trials with that drug. At this phase, the probable efficiency of the drug is determined, and possible risks are identified. Its observable efficiency and the seriousness of the disease allows it to move to phase 3
- Phase 3: At this phase, more people with the disease are used. This phase tests for further effectiveness. It closely observes the side effects and compares the drug’s effects to a standard treatment if any is available.
- Phase 4: This is done after the approval of the product and its distribution in the market to identify any more long-term risks, benefits, and maximum use. It can also be done to test the product in other populations such as the children.
During this trial, random administration of the product is done using a computer to prevent any form of preferences that a physician may have. A feature known as blinding is also done to prevent any form of bias. Single blinding ensures that the participant does not know whether they are receiving the drug being experimented on, a placebo, or an already established drug. A double-blinded trial is also done where neither the participant nor the team doing the trial knows which participant will receive the experimental drug.
How People Are Protected?
Federal organizations regulate trials and protect participants. The Human Research Protections (OHRP) office in the Health and Human Services (HHS) department ensures human protection during the trials. The Food and Drug Administration (FDA) also protects the rights and welfare of drug testing volunteers. It does so in various ways, including verifying the quality and integrity of submitted data.
The discovery of drugs is a crucial activity that helps us combat diseases easily. Most importantly, volunteers in drug testing experiments deserve utter respect. They undergo the process even with the various risks made known to them. Volunteers need to have the information above so they can make informed decisions about participating in clinical trials.
