According to meta-research, up to 50% of all clinical studies are repetitive and bring little benefit to patients. And owing to how 2020 ended, the science sectors have been forced to rethink and restructure their trials designs into more patient-focused ones. This redesign is to be included in addition to what patients expect, for instance, patients’ safety. For this reason, a clinical research organization (CRO) like Veristat and its sponsors have been looking for ways to improve their clinical trial design and acquire data from still-running trials in a secure manner. Some of these ways include;
Using technology to reduce burdens
Advancements in technology have made it possible for researchers to carry out clinical trials remotely. This reduces the need for in-person visits which in turn reduces the burden often laid on the patients. Such advancements also help to make trials more patients centered. The availability of at-home equipment such as oximeters has also led to an increase in patients enrolling in clinical trials. This is because patients can quickly and conveniently register, test, and record their details, then sends them to the trial investigator in the comfort of their homes. Since this information is sent electronically, the need for trial investigators to travel to the sites for data reviews has also been reduced, thus reducing the trial cost. However, not all tests can be done remotely, and this can limit come clinical trials from being entirely remote.
Using adaptive designs
The FDA is required under the 21st Century Cures Act, passed in 2016, to offer updated recommendations on how research organizations can use adaptive trial designs. This has seen adaptive designs become more practical. With such designs, data is garnered from two reliable sources; patient-level data from previous trials and data from electronic health records. This information is then utilized to determine the proper amount of patient-to-patient variability expected from a trial, which helps predict when the results of a study will be mature enough for adaptive designs.
Optimizing for speed
Flexible designs can help clinical trials boost their chances of success, save money, and obtain answers faster, all at the same time. By correcting assumptions that could otherwise obscure a drug’s true potential, such as how a disease will progress, flexible designs can improve its chances of success. Though it’s difficult to say how many studies have failed due to design errors, the FDA found that avoidable flaws, including the inability to identify appropriate therapeutic doses, were among the reasons for disapproval in a review of 150 failed drug applications. Since optimizing for cost by staging the trial’s investment under the old clinical research approach slows it down, researchers should consider pursuing more programs by optimizing for speed. This helps minimize spending on studies that will ultimately fail.
Redesigning clinical trials into adaptive designs could help reduce the time, effort, and resources used in undertaking less promising trials. It will also reduce the instances where assumptions interfere with the drug’s effectiveness. Through technology, trials can adapt better and improve ways of functioning.
