Immuno Oncology CRO Trials play an important role in improving personalised cancer treatment.
Essentially, a trial is an evaluation of a new therapy or a new combination of therapies to see if it might be a useful and helpful approach to treating cancer.
Almost any therapy a cancer patient receives is in some sense a trial to see if it actually helps and benefits the patients in controlling the cancer and this is measured usually by radiographs, CT scans or other kinds of scans to see if the cancer is actually being controlled.
Immuno Oncology CRO trials occur in different phases and generally Phase 1 trials involve taking a brand new drug or a new combination of drugs to determine which the safe and tolerable dose of the drug is.
Phase 1 trials are about testing safety. A combination of drugs may also be tested to determine, what is the right dose to combine with another drug so that they can be safely taken together and
While phase 1 trials are often thought of as the most experimental and maybe from a patient's point of view, the least desirable, quite the opposite is true. Phase I clinical trials give access to new therapies that can hopefully make a bigger difference than existing therapies.
In later stage clinical trials drug X is compared to drug Y to determine which one is more effective.
What are the Eligibility Criteria for Immuno Oncology CRO Trials?
This is a question which patients need to be aware of when searching for clinical trials on the cancer research institute website. They can compile a list of 20 to 30 trials but patients aren't necessary eligible for every one of those trials.
Eligibility requirements vary from trial to trial and are often very strict and rigid for a reason. A clinical trial is really an experiment to try and prove whether a therapy is safe, beneficial or more effective than another drug depending on the phase of the trial.
For this reason, Oncology CRO services companies make sure that the patients in the trial meet two different standards - one that they are going to be a relatively uniform population so that the CRO can be confident that there aren't other variables that are responsible for the benefit or lack of benefit in those patients.
Second, that patients actually meet particular criteria that would make this a safe type of therapy for patients to participate in. This is probably the most critical factor when testing a new drug.
Since the side-effects of the drug being tested have not been fully uncovered,
Immuno Oncology CRO services companies want to make sure that the drug will not cause harm.
For instance, if a drug is likely to have effects on the liver if metabolised in the liver, then one of the eligibility criteria will be that the patient must have normal liver function.
One of the criteria used for safety purposes is that patients with autoimmune disease or susceptibility to really inflammatory conditions are excluded to avoid the risk of turning an inflammatory condition into something life-threatening.
Logistical Considerations for Immuno Oncology Trials
This is a key part of a clinical trial because the earlier the phase of the trial, the more number of patients need to be involved.
When evaluating safety there's a lot of monitoring that occurs in the clinical trial. This often means more frequent visits for extra blood tests to monitor how the drug is metabolised or cleared out of the body.
There also can be other kinds of evaluations for instance such as biopsies or sampling to try to understand how the drugs are working. This is particularly critical in evaluating immunotherapies.
Immunotherapies are often drugs that haven’t been fully understood and require
samples to be taken from patients being treated with these therapies on clinical trials.
Immuno Oncology Trials Involving Multiple Drugs
There are differences in terms of what patients should expect when receiving more than one drug at a time, than if they were just receiving one drug.
When adding on drugs that can modulate or affect the immune system, there is a risk of toxicities. For instance the most extensively tested combination in lung cancer is a combination of a pd-1 inhibitor called Nivola map with a ctla-4 inhibitor called if the Illuma map.
These are two different targets on immune cells that modulate whether t-cells become active and can kill things around them kill abnormal cells but both of them are normally regulating your immune response and controlling immune response. When both the signals are blocked it can lead to a higher risk of inflammatory side-effects or autoimmune side effects.
Oncology CRO services companies take extra caution when giving a cancer patient new drugs to make sure that they have a higher chance of benefit than risk.
There are many drugs targeting different players in the immune microenvironment.
It is difficult to know which combination of drugs is going to ultimately be successful so there are many more umbrella protocols which involve building different combinations into the same trial.
Enrolling in Immuno Oncology Trials
Scientifically assigning the right person to the right trial depends on what is the right trial at the right time for an individual patient.
Working with the family doctor is critical to making a decision because a major factor influencing the decision is the logistics.
There are many options with good potential and the choice to participate depends on of what trial is available, whether a patient meets the eligibility criteria and one which will be the least disruptive to a patient’s quality of life.
Participating in the CRO should help in maintaining or improving a patient’s quality of life and benefit others as well.
The patient should also be able to travel to the oncology cro trial site on the dates and frequency that’s required for as long as required.