Understanding the Clinical Research Process for Pharmaceutical Products
Clinical research is conducted around the world each and every day. This testing is completed for medications, medical equipment and products to identify their safety, effectiveness, benefits and adverse effects.
Pharmaceutical products have to go through very strict phases and stages to ensure that they are effective and safe. With diseases such as HIV, cancer, diabetes and more, scientists and researchers are constantly working on new medications to help slow and eliminate these disease, but this all has to be tested before it can be made available to the general public.
This all starts with the developmental stage. The developmental stage will identify how the medication is absorbed into the body, the potential benefits, dosage requirements and any side effects. These tests are only theoretical at this point and have not been tested on humans. It is what the research or scientist believes, but in order to have it FDA approved, it has a number of other steps and hoops to go through before it is considered safe for human consumption and can start making a positive difference to lives on a global scale.
Once the developmental stage is completed, the medication will enter the pre clinical research phase. This stage is often carried out in a laboratory using both in vitro and in vivo to learn more about the product, get a detailed overview and confirm it is safe for human testing. Any doubt in the products safety in humans will stop it going to the next stage of the clinical trial which is the human testing phase.
When the medication has effectively passed the pre clinical research stage, then it goes onto the clinical research phases, which comprise of four phases to identify if the product is safe, how effective it is, learn about side effects, risks and benefits.
Initially a specialist company or the pharmaceutical company will start choosing their participants to take part in the trial. This will include a number of factors including age, gender, medical history, health and more. They will also identify how many participants they need to ensure that they get a clear overview of the product to submit to the FDA. Participants can vary from forty or fifty participants to a couple of hundred participants.
Dosage and assessments will be determined and then the clinical research will enter trial one. Phase one usually lasts a couple of months, usually focusing on the products safety aspects, with only seventy percent of pharmaceutical products going onto phase two. Phase two can last up to two years, depending on it’s success, this focuses on the effectiveness of the product. Only around thirty three percent of products make it to phase three of the clinical research project.
Phase three is a long term process which can last up to four years. During this time the larger scale aspects of the medication is tested with participants being very closely monitored and supervised. This is to determine any benefits of the product, along with any adverse side effects. Everything has to be detailed and recorded to submit to the FDA for approval.
Only up to thirty percent of pharmaceutical products make it to the fourth and final stage. On completion of the fourth stage, documentation is collated and passed onto the FDA for consideration to be made available to the general public to improve quality of life and make a difference in lives on a global scale.