Key Considerations When Designing Oncology Clinical Trials

Doctors use oncology clinical trials to determine the safety and effectiveness of cancer treatments as well as whether they function better than existing treatments. Clinical trials also aid in the development of innovative methods for cancer prevention and detection. They also assist us in improving people’s quality of life while undergoing treatment and thereafter. As such, a clinical trial design by reliable organizations like Veristat is done with consideration of all the key elements involved in each phase of the trial. Some of these considerations include;

Phase I

Phase I has for objective; determine the infected organ system, determine the maximum tolerable dose, research on the pharmacologic properties of the drug, and gather evidence on the efficiency of the treatment.  In this phase, there are various points of consideration during your clinical trial planning but we will look at;

Patient selection

In phase I testing, it can be done of different categories of patients including volunteers, heavily pre-treated patients, untreated patients, and patients in an advanced stage of an illness such as cancer.  In deciding which patient population to perform tests in this phase, clinical trial planning must consider; the expected effects of the drug based on previous clinical trials, the existing treatment options for the patients, and the possibilities of generalization of results. However, all this can be achieved if there are heavily pre-treated patients in advanced illness stages whose treatment options are few. The problem with this approach is that gathering reliable information on treatment efficiency may be difficult to obtain.

Phase II

In phase II, the main objectives are; estimation of response and toxicity rates, determining treatment feasibility, and perhaps determining the best treatments for testing in phase III. In this phase, researchers focus on learning about the efficiency of new drugs. When designing the trial, regarding patient eligibility criteria, the strictness and interpretation of the criteria must be considered. Studies of the new agents are often done by one investigator at a single site. As a result, with patients’ referral patterns and the investigator’s interpretation of the criteria, there is no generalization of the results with other results from other sites with the same patient category. Though this may not be problematic in phase II, the problem is faced in phase III testing due to the biases in the patient selection that often favor the new agents.  Let us also look at;

Early stopping

The oncology trial must also consider the use of a design that allows early termination of studies when large or small responses and toxicity are recorded.  Such designs are called; sequential. Such designs allow for interim results to be examined and decide whether or not the trial should be continued on a larger size. The designs also allow for ethical compliance as patients can be evaluated before they are subjected to a new agent. In the face of an inferior agent, this allows investigators to reduce the number of patients used in the trial.

Phase III

The purpose of phase III is to search for relative treatment and toxicity effects. Like phase II, this phase faces biases and errors from poorly planned studies. To eliminate and even control the biases, the study phase incorporates randomization and blinding, and sometimes stratification. We will look at;


Randomization guarantees that treatment selection will not be biased towards a patient’s prognostic factors. This means differences in treatment results will be based on treatment effects and random variability. This is often achieved through statistics which can control variability hence enabling the estimation of the unbiased treatment effect.

t’s critical to keep in mind the special problems that come with oncology clinical trials when planning and performing them. Finally, these considerations can aid clinical trial success and increase the number of novel therapies available to patients who require them.


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Emilie Collard