Everything you need to know about adaptive clinical trials

As a research investigation, clinical trials traditionally test a single new drug or a specific part of a treatment, and it is common for only one pathway to be tested at one time. Furthermore, although there is no set time frame for a drug or treatment to be tested in, it can take years for a trial to generate results, whether the outcome be negative or positive. This is usually due to the inflexibility of such trials.

The problem with conventional clinical trials is that patients with progressive illnesses, such as brain tumours, do not have enough time to participate in various trials that only explore a single potential treatment at a time.

What are adaptive clinical trials?

In contrast, an adaptive clinical trial provides researchers with the opportunity to alter the trial by modifying the combination of therapies, or by introducing new drugs in correspondence to the improvements or deterioration a patient may experience as a consequence of the treatment.

Researchers may alter such aspects of the adaptive trial, including the criteria by which patients are selected, the dosage of the drug and the mix of drugs administered. It’s a continual process that can add or abandon drugs in response to information acquired. Phases of the trial are still adhered to, including the adaptive phase 1 studies, including those found at http://www.richmondpharmacology.com/specialist-services/adaptive-phase-i-studies, in accordance with the set protocol.

Although modifications are made during the process of an adaptive trial, data does not need to be shared with the relevant authorities or committees, only in the event that researchers wish to implement alterations to the trial that go outside the boundaries that have previously been approved.

For a comprehensive understanding of the differences between conventional trials and adaptive ones, click here.

Aim of adaptive trials

The overall aim of an adaptive clinical trial is to accelerate identification of treatments or drugs that have a positive effect on the patient. By developing a flexible approach, organisations that conduct adaptive trials can produce outcomes in a more efficient manner.

Patients also receive increased benefits. For instance, if a type of medicine shows apparent perks towards a disease, researchers can decide to increase the sample size so that the studied drug can get to the hand of more patients in need. Especially in case of cancer, this adaptation serves undeniably well.

As a result, new treatments can be introduced to the market quicker than those from a conventional trial. Moreover, adaptive trials ensure that more patients affected with an illness can participate in clinical trials, giving the opportunity to try new treatments that can have a positive effect.
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