Randomized Concentration-Controlled Trials (RCCT)

Better Controls on Exposure Variability

Randomized concentration-controlled trials (RCCTs) are a type of clinical trial design that involves controlling the concentration of a drug in the blood of study participants. In an RCCT, the dose of the drug is adjusted based on the concentration of the drug in the blood, rather than being fixed.

Key Features

The following are key features of randomized concentration-controlled trials:

  1. Drug concentration control: In RCCTs, the concentration of the drug in the blood is monitored and used to adjust the dose of the drug. This allows for individualized dosing, with the aim of achieving a specific target concentration or exposure level in all participants.

  2. Randomization: Participants in an RCCT are randomly assigned to receive the drug at a specific dose or at a dose that is adjusted based on their individual drug concentration levels. This randomization helps ensure that any differences in the outcomes between the groups are due to the intervention and not due to other factors.

  3. Blinding: In an RCCT, participants and study staff may be blinded to the dose of the drug, which is adjusted based on drug concentration levels. This helps to minimize bias in the study results.

  4. Pharmacokinetic/pharmacodynamic modeling: RCCTs typically involve the use of pharmacokinetic/pharmacodynamic (PK/PD) modeling to estimate the relationship between the drug concentration in the blood and the clinical response. This modeling helps to guide the dosing adjustments and determine the optimal target concentration.

  5. Primary outcome: The primary outcome of an RCCT is usually a clinical endpoint that is relevant to the therapeutic effect of the drug, such as symptom improvement or disease progression. The aim is to determine whether the concentration-controlled dosing approach results in better clinical outcomes than fixed-dose regimens.

RCCTs have several potential advantages over traditional fixed-dose trials, including improved efficacy, reduced toxicity, and improved safety profiles. However, they may also be more complex and expensive to conduct due to the need for frequent drug concentration monitoring and dose adjustments.

Interested in learning more about Momentum Metrix’s randomized concentration-controlled trial capabilities, contact us at information@momentummetrix.com.