The foundation of a good clinical trial is planning. The steps you take before you ever distribute the first medication or treatment can lay the groundwork for easy data collection and positive patient experiences. The developmental stage in a trial can ensure the data is usable, accurate and defendable. You can present your information with confidence and bring a drug to market in good time.
Successful preplanning requires the right tools. Here’s how RTSM Master by Anju Software can streamline this process so you can move forward with your clinical trials.
Recruitment is a major part of clinical trial development, and needs to be done effectively. While an organization might have dozens of interested participants, their recruitment efforts are all for naught if none of them are qualified to receive the treatment. Ineffective recruitment can slow down the trial process as researchers try to find the right patients.
An effective pre-screen process can help researchers identify whether a patient is qualified for a clinical trial.
“When a patient is identified, the research organization should have an effective screening process that is minimally invasive and/or requires little travel,” according to biotechnology company Neoteryx. “Technologies such as remote sampling have made such processes possible. Identified candidates can submit samples from wherever they are and at any time without visiting the research facility. Little training is required for sample collection.”
With the right patients ready to start a clinical trial, researchers can move forward with different treatment groups. Randomization is key to removing bias and protecting the integrity of trial data. While randomization may vary by trial, the goal is to ensure demographic factors don’t lead to biased results.
“There are really no cons to randomization,” writes Jack Knorr, senior research scientist at Eli Lilly. “Research teams don’t lose anything by doing it and gain a lot of benefit. Several studies also compensate for requiring participants to be on placebo by ensuring that participants get access to the investigational medicine once the primary portion of the study is over.”
The RTSM Master has a randomization simulator that enables you to analyze large numbers of potential participants. You can set various parameters and goals to ensure you account for any bias in your trial design.
Clinical trials operate against a ticking clock. The longer trials take, the greater the chance that patients drop out or decide against participation. This further slows your trial as you will then need to recruit and screen replacement patients. Slower trials also prevent you from submitting your treatments to the FDA for approval in a timely manner, which in turn keeps the drugs off the market for the patients who need them.
“The clinical trials enterprise is just hopelessly complicated,” says retired cardiologist John H. Alexander, director of cardiac simulations at KindHeart. “There are two key goals in a clinical trial: one is to protect participants and not put them at unnecessary risk; the other is to collect high-integrity data to answer the research question. There are just dozens of things that we have layered on that don’t achieve either of those goals.”
The right software systems can reduce unwanted barriers that slow your trial and frustrate patients and researchers alike. They can protect the integrity of your study without bogging it down.
Not all clinical trials are successful, but no one wants to end a trial because of incomplete or incorrect data. With the right planning, you can find qualified patients who will randomly receive the treatment or a placebo. You can protect the integrity of the data while creating a positive patient experience. You can also continue to learn from and rely on the data collected in your clinical trials, improving the treatment as needed and moving forward with confidence.
Learn more about RTSM Master by Anju today and see how it can improve your trial processes.
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