Clinical trials are research studies that are meant to advance the care options that are available for a given ailment. The idea is to ascertain how potential options interact with the human body. Of course, this means that persons must volunteer to become a part of such initiatives.
How Does Clinical Trial Eligibility Work?
While it would be nice to imagine that anyone with the desire is eligible, that is not how it works. Clinical trials have requirements for participation that must be met. These are collectively known as the eligibility criteria. Typically, some of the data points of interest are:
- Risk factors
- Health
- Medical history
- Family medical history
- Treatment history
- Age
Truthfully, there is an inherent risk in clinical trial participation. After all, the treatments are usually new, which means that they are not fully understood. Evaluating eligibility requirements minimizes the level of risk, though it is not eliminated.
Apart from reducing the likelihood of harm to participants, there is also a need to ensure that there aren’t great medical differences among people who are a part of a given trial. This makes it easier to conclude that any results are not based on external factors.
What Are the Phases of Clinical Trials?
Clinical trials tend to go through a series of steps. This is especially true when testing new cancer treatments. Transitioning to a new phase will typically depend on the results of the current one:
- The first phase of a trial is where researchers will try to figure out the safety of a treatment option. Concerns include tolerance, side effects, and appropriate dosage. You will typically find that the groups of people participating at this stage are very small. Most importantly, there must be some form of validation that the treatment has some kind of effect on the ailment.
- In the second phase of the clinical trial, there is a greater focus on the extent to which the treatment matches the condition. For example, if a form of cancer is being studied, observations will be made about tumor changes, such as slowed growth or size reduction. Studying safety is still important here, and special attention will be paid to short-term side effects.
- The third phase of the clinical trial will aim to compare the current standard of treatment to the proposed therapy. Additionally, the side effects of both options will be contrasted. Participants will usually be randomly assigned to one option or another, which ensures that notable differences are real.
- While results from the first three phases will be used for the approval of new treatments, there is a fourth phase that is concerned with long-term efficacy and safety.
Bias and Randomization
As indicated before, it is very important to ensure that randomization is taking place in clinical trials. This will typically include assigning people to groups by random chance, especially when these groups are meant to receive different drugs or interventions. In most cases, a computer will be used to decide on the assignments.
In the most simplistic form of assignment, there is an investigational group that receives the drug or intervention that is being tested. Conversely, there is a control group that is administered the standard treatment.
The idea of this randomization process is to prevent bias, which can only occur when the results of a trial are affected by choices made by humans. Recall that there should be no other factors at play than those directly related to whatever treatment option is being tested.
What Does the Research Team Look Like?
Running a clinical trial successfully requires a team of experts with varying skill sets that come together. There may even be different sites in a single trial that do not have the same team composition. Nevertheless, here’s a look at the typical team members:
- Principal investigator – As the name implies, this is the person who will be supervising every aspect of the clinical trial. Some of the associated duties will be directing participant recruitment, writing protocols, developing the concept, and managing informed consent processes.
- Data manager – This is the person who will be managing the collection of all data obtained throughout the clinical trial. The data manager will work with the principal investigator and research nurse to decide what points of information are worth tracking.
- Research nurse – Patient care is the responsibility of the research nurse. Additionally, this is the person who will educate referring healthcare providers, participants, and staff about the trial. Regular communication with the principal investigator is required.
- Staff nurse or physician – This is another person who will be taking care of patients during the trial. Responsibilities include treating patients based on an established protocol, assessing treatment response, and reporting whatever trends may be observed.
Why Should Residents of Denver, CO Consider Clinical Trials?
Clinical trials in Denver are good options for those who have ailments with no cure that are actively being researched. For many people, they have represented a way to gain some semblance of control in the world of health.
Apart from being motivated by your own needs, there is also the fact that participation represents assistance in understanding more about treatment options for the wider public.
You will also find that there is some level of benefit to interacting with others who are dealing with the same condition.
Finding Clinical Trials in Denver
The first step to taking part is finding a clinical trial that is specific to your ailment. Of course, you will also need to meet the associated eligibility requirements before you are allowed to participate. Bear in mind too that not all clinical trials offer compensation.
UCHealth Is one option that you can consider to locate an appropriate trial. There is a searchable database maintained that can help you to see where you can fit into the hundreds of trials being conducted.
WCG can also assist in the location of an appropriate clinical trial. For each state, different cities are listed, as well as the number of active studies taking place. Therefore, you would simply need to look for Denver listings under Colorado.
Finally, you can consider Velocity Clinical Research, which services the Denver Metro area. This site is centrally located, and it even happens to be 2 miles away from a local hospital.