Whether you’re knowledgeable on Clinical Trials and the process that goes into it or not, it's correctly assumed that the work is far from light. There are four phases for each study conducted that tells the plot of the story, but doesn’t dive into the supporting elements within.
As defined by Margaret Rouse on WhatIs.com, “A clinical trial, also known as a clinical research study, is a protocol for evaluating the effects of experimental medical or behavioral interventions on health outcomes.”
Participants usually tend to be volunteers in which data is collected. They're usually funded by Federal Government places such as the National Institutes of Health, Department of Defense, and the Department of Veteran’s Affairs.
Studies are also funded by private industries such as pharmaceutical and biotech companies, medical institutions, and foundations.
The National Institutes of Health (NIH) and the Federal Drug Administration (FDA) require these four phases to be practiced before submitting. The phases are explained below:
With a small group of volunteers (20 to 100 usually paid), experimental drugs are tested by researchers to grasp the idea of its safety and the correct dosage. This is also the phase where any side effects are determined.
This usually takes several months to complete, about 70% of drugs pass this stage.
At this point, a larger group of volunteers is given the experimental drug to further validate its safety. This phase tests the efficiency of the drug and requires several months to two years for completion. It also requires several hundred patients.
The study consists of randomized trials where one of the group tests the experimental drug.
The second group (control group), is given the standard treatment. This is essential to compare the effects of the drugs also known as “blinded” studies. With this information, the FDA and pharmaceutical companies can fully understand the safety and effectiveness of the drug.
Approximately one-third of drugs pass this stage.
As randomizing and blinded testing continues, the number of patients rises to several hundred to several thousand. This phase can last several years, giving the FDA and pharmaceutical companies even more to look at.
They can detect the effectiveness of the drug, benefits, and problems that patients may run into. About 70% to 90% of drugs complete this phase.
Once completed, it can be submitted for FDA's approval for sale.
This phase is conducted after the drug has been approved for sale. Otherwise called, Post Marketing Surveillance Trials.
To complete this phase, pharmaceutical companies must compare the drug with others to test the market. Then, they must monitor its long-term effectiveness and how it impacts the patient’s life.
Lastly, it must be determined how the drug stands in terms of cost with other drugs already on the market.
Through all four of these phases, the amount of data that must be collected can be overwhelming. Whether it’s individual data for each patient, financial planning, or recruitment tracking, clinical trials are easily taken care of by technology.
As we’ve seen so many life-changing technological advances over-time, Clinical Trials Management System (CTMS) Databases is another to add to the list.
Companies and individuals around the world are adapting quickly to the technologies such as the Cloud, Internet of Things (IoT), Artificial Intelligence and other Machine Learning devices related to clinical trials.
The realization is that technology can enhance the productivity and produce better outcomes quicker. The systems that many companies use for their Clinical Trials have many benefits. Starting with the organization.
No matter what industry of work you’re in, lack of connected systems and operations can result in delayed processing, increased cost and user frustration. Instead of inserting specific dates and required documents into many files, data management systems can hold everything you need in one place.
It’s like when you lose something that was a piece of something bigger. Your first thought can be, “I really wish everything could just stay together!” Well, now it can. This makes managing clinical trials very easy to find anything you need, at any time.
Flexible Data Entry:
Let’s be honest, the different kinds of technology people use today greatly vary from different applications, devices, and software. For the companies conducting clinical trials, it's easy to input any data from anywhere in one destination.
That takes away any limitations that you might’ve thought of. Again, making running clinical trials easier.
In this day in age, it’s safe to say most tracking and analyzing is done by professional analytics. Sports statistics are now down to the exact decimal, close to every entry of data possible is kept in all business, and now clinical trial data is on its way.
There’s a lot of data available to analyze and apply. With the worry of analytics out of the way, the technology we have today allows users to focus more on the results and less on the numbers.
These are just three of the benefits Clinical Trial Management Systems can assist companies with.
Making a drug to positively impact the quality of life for some is for sure something to be proud of. As said in the old Spider-Man movies, “With great power comes great responsibility.” Yet, with a Clinical Trials Management Software, the responsibility is cut down drastically.
So, all that’s left to focus on is the power.
With iPhones upgrading and running the lives of many, Apple watches becoming more common every day, and even SmartCars taking over the roads, we are seeing technological advances everywhere.
The pharmaceutical industry has been rolling with CTMS and it has not disappointed.
Not only does this technology benefit the user conducting the study, but it also benefits the quality of drug for the FDA to approve or not. Given the detailed and specific data kept organized, this will help keep the results the same way.
The job for everybody in the lifecycle of clinical trials has become extremely easier driving the most accurate results.