What Are the Steps Involved in Clinical Trials?
If you watch the news, it might seem like there are new medical conditions and strains of diseases popping up all the time. Luckily, new treatments are being researched all the time, with advances and discoveries constantly helping to improve the healthcare landscape.
Clinical trials are a key part of that process. They not only allow researchers to learn more about useful compounds, they also help keep patients and trial participants safe through the use of rigorous methodology.
Maybe you’re a student considering a career in pharmaceuticals. Maybe you’re a patient looking for more treatment options, wondering “are any medical trials near me?” Maybe you’re just curious. Whatever the reason, Adare Pharma Solutions wants to help you better understand how medicines are developed.
These are the five main steps of clinical trials:
1. Initial Development
The first step in the process of refining a new medicinal treatment involves the initial discovery and development of a potentially beneficial compound. This is often the result of new technological advancements or new insights into how a specific disease works.
In determining a compound’s efficacy as a treatment, researchers conduct tests in order to better understand how the compound is absorbed and metabolized in the human body, what the optimal dosage and delivery system is, what adverse effects it might have, and how it reacts with other medicines.
2. Preclinical Research
Before researchers can conduct trials with human patients, it’s important to determine how to do so as safely as possible. That means FDA-approved GLP (Good Lab Practices) to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity.
Preclinical research is done in a laboratory, rather than a clinical setting, and is typically done in either one of two ways. The first is called in vitro, which is Latin for “within the glass.” As the name implies, in vitro experiments study compounds primarily in glass test tubes. The other is called in vivo, meaning “within the living.” In vivo experiments use live biological matter, such as cells, plants, or sometimes small animals.
3. Patient Testing
When research indicates that a new compound is safe, true clinical testing can begin. Although preclinical research provides valuable data about the nature of a compound, the only way to accurately gauge how its effects on the human body is to use human subjects. Clinical trials consist of multiple phases, starting with a small pool of participants observed over short period of time and gradually increasing to thousands observed over the course of years.
Since, by this point, safety has been well-established, a major focus of clinical trials is learning how well the tested medicine works, especially in relation to currently existing treatments. Another emphasis is in finding out which side effects are most common and how severe they may be.
4. FDA Review
It is estimated that only about 25% of all drugs make it beyond clinical trials. In many cases, researchers find that their compound is either not effective enough or that the side effects outweigh its potential benefits. Those medicines that do make it have their research findings submitted to the FDA for review.
The review period may last around 6-10 months, as the FDA review teams closely examines all the information and test results. While this is happening, FDA inspectors investigate the researchers’ clinical sites to ensure no data has been manipulated, fabricated, or omitted. In the end, the review team makes a recommendation to a senior FDA official who has final say on whether or not the new treatment is approved.
5. Safety Monitoring
Just because a new medicine has been approved by the FDA, that doesn’t mean there’s not more to learn from it. Nor does it mean that public safety is deprioritized. Even after the drug makes its way to market, the FDA and pharmaceutical developers continue monitoring its usage.
Even long-term clinical studies cannot fully determine how a medicinal treatment might affect patients over its full lifetime. Some side effects only present in incredibly rare circumstances that are unlikely to have occurred during the study. Subsequent reports may impact recommended dosages or even result in unexpected breakthroughs.