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Important Features Of Clinical Trial Design

Clinical trials are research studies designed to explore if a medical strategy, device, or treatment is effective and safe for human use. And an Oncology trial design by reliable research organizations like Veristat is no different. It’s laid out to determine whether a pharmaceutical product is safe and effective for cancer patients. These research studies also show the best medical approach that is the most effective for patients. The studies also help improve patients care. Clinical trials have important features that ensure their success. They include:

Alternative Hypothesis

The first feature in an oncology clinical trial design is an alternative hypothesis which is the claim that you want to make upon completion of the trial. It’s a scientific method that states that “in order to prove something, you have to assume the compliment is true” therefore look for contradictory evidence. This hypothesis is what the trials desire to prove as true. For example, a hypothesis showing that the treatment is better than a placebo. You assume that the compliment, referred to as the null hypothesis, is assumed to be true and then proceed to look for evidence that disapproves the null hypothesis. Disapproving the null hypothesis means that you now claim that the alternate hypothesis is true.

Null Hypothesis

This is a claim that you wish to prove as untrue. It is the opposite of the Alternative Hypothesis discussed above.

Intent To Treat – (ITT)

This is the strategy that you wish to conduct the trial and analyze the data with. The strategy aims to analyze that data regardless of the results of the treatment received.

Phase 1

The main objective for phase 1 in the trial is to assess whether the drug is safe for human consumption and what doses are safe. During this phase, you should predict if there is any toxicity associated with the drug. You will need to collect data on the dose-response connection and the safe dose range, as well as its side effects. This phase is performed by a clinical pharmacologist and takes about six months to end.

Phase 2

At this phase, the drug is administered to patients to see further if the drug is safe. You get to see whether the drug has the desired therapeutic effects on patients. You will also compare the effectiveness of the drug with the drug that currently exists in the market. This phase has 20-200 patients with the illness being researched.

Phase 3

This phase is done on a large scale and is more randomized. It targets to have 250-1000 patients for the trials and clinicians perform it in a hospital setting. This phase will confirm whether the drug has the desired effect and works for its ultimate general use. You will also compare experimental drugs against the new therapies to see which works better for the patients.

Post Marketing Surveillance

This is the study done after the drug is marketed to gather information from different populations. It also studies the long-term effects of the drug, drug interactions, and new drug uses.

A successful clinical trial has to follow all the features for its ultimate success. Skipping any of these steps might invalidate your trial and loss of a huge investment.

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