Clinical trials are an integral part of the drug development process, serving as crucial platforms for evaluating the safety and efficacy of new medical interventions. Over the years, clinical trial practices have undergone significant transformations, driven by advancements in technology and a growing emphasis on efficiency and patient-centricity.
The landscape of clinical trial practice continues to evolve in 2023, with a focus on optimizing trial supply management through the adoption of innovative systems like IRT (Interactive Response Technology), RTSM (Randomization and Trial Supply Management) support and improved blinding techniques. These advanced technologies streamline and optimize trial operations, enhancing data accuracy, patient safety and overall trail efficiency.
According to a study published in the Journal of the American Medical Association (JAMA), trials that implemented IRT-based randomization experienced a 25% reduction in potential bias compared to conventional methods.
IRT System and RTSM Support
One of the key developments in clinical trial practice is the increasing utilization of IRT systems, which integrate various functionalities to streamline trial operations. IRT systems, such as randomization, drug allocation and trial supply management, have proven invaluable in enhancing efficiency, accuracy and data quality in clinical trials.
According to a survey conducted by Industry Standard Research (ISR), 75% of clinical trial professionals reported using IRT systems for trial supply management and randomization processes. The survey highlighted that IRT systems significantly reduced drug wastage, improved drug accountability and facilitated real-time monitoring of supplies, leading to enhanced trial execution.
The adoption of RTSM support, which combines randomization and trial supply management functionalities within a single platform, has gained traction this year. This integrated approach enables seamless management of patient enrollment, randomization, drug allocation and inventory control, minimizing errors and ensuring the availability of necessary supplies throughout the trial.
Anton Enchev, Assistant Project Manager, HCLTech stated: “The purpose of IRT systems is to control patient’s randomization efficiently and accurately. This application automates the drug supply and the resupply to the depots, sites and handling drug dosing and dispensation.”
He adds: “We started working with a top pharma company in 2014 on a project to create an in-house system for randomized patients and managing medication supplies to old hospitals (called sites). This system randomizes patients and dispenses medication to those patients who are participating in clinical trials.”
Randomization in clinical trials
A study conducted by the NIH (National Institute of Health) found that proper randomization in clinical trials significantly reduces the likelihood of treatment group differences, resulting in more accurate and robust findings.
Randomization is a crucial aspect of conducting clinical trials, as it helps to ensure the validity and reliability of the results obtained. By randomizing participants into different treatment groups, researchers can minimize bias and confounding factors that may influence the outcomes. “Randomization is one of the most important processes in clinical trials. To prove if a drug is efficient, in most cases, one needs to compare it with a drug that is already available in the market. So, when the patient signs up to participate in a trial, the system decides if the patient will take the test drug or the one that is available on the market. This process is called randomization,” adds Enchev.
The system is set in a way that ensures that the ratio between the patients on the test drug and the patients on the treatment being tested is kept as per the protocol requirements. One of the most important factors when deciding if the new medicine is effective is also unbiased results—new results without any influence, tweaks or inputs by any of the participants.
Blinding, the process of withholding information about the assigned treatment from patients, investigators and other study personnel, remains a critical aspect of clinical trials to minimize bias.
Commenting on blinding, Enchev states: “There are different levels of blinding. Generally, neither the doctor nor the patient knows what drug the patient is taking. Whether it's the new drug, or the one that is already available in the market. In addition to randomizing patients, the system does not tell what type of medication it dispenses—it just tells the doctor which box they need to give to the patient, without specifying what context. The box just has a number on it and the system says give this box with this number to this patient.”
Preserving the blinding is one of the most important things in the clinical trial to prevent bias, which occurs when the trial’s results are affected by human choices or other factors not related to the treatment that is being tested.
However, maintaining blinding integrity presents challenges in trial supply management. To overcome these challenges, innovative blinding techniques are being employed. For example, the use of dummy packaging, identical in appearance to the active drug, helps maintain blinding while facilitating accurate drug dispensation. In 2023, advancements in printing technology have enabled the creation of visually indistinguishable dummy packaging, further enhancing blinding integrity.
Challenges in trial supply management
Despite the progress in clinical trial practices, several challenges persist in trial supply management. These challenges include complex supply chain logistics, demand forecasting uncertainties and manual dispensation processes.
Supply chain disruptions caused by global events, such as the COVID-19 pandemic, have highlighted the need for robust contingency plans to mitigate risks and ensure uninterrupted supply of investigational drugs. Moreover, accurate demand forecasting remains a challenge, as variations in patient enrollment rates and protocol amendments can impact drug requirements.
Enchev adds: “Insufficient supply is a critical logistic challenge. For instance, the patients in the hospital wait for medications but the system may not have enough medication. In such cases, the state is usually asked to reschedule the visit. But this is not always possible, as some patients have traveled long distances or there might be a health risk to the patient with the dely.”
Optimizing the trial supply management process
To optimize the trial supply management process, several strategies can be employed:
- Implementing real-time inventory management: Utilizing advanced technologies, such as IoT-enabled sensors and RFID tags, enables real-time tracking of drug supplies, reducing the risk of stockouts or excess inventory.
- Leveraging predictive analytics: Integrating historical data, enrollment patterns and other relevant parameters into predictive analytics models assists in accurate demand forecasting, minimizing drug wastage and delays.
- Embracing automation: Automating manual processes, such as dispensation, reduces human errors, improves efficiency and ensures adherence to protocol requirements.
The clinical trial landscape is evolving rapidly, driven by technological advancements and a focus on optimizing trial supply management processes. The players in the ecosystem are constantly working towards making meaningful and creative use of technology to bring together applications, infrastructure and IoT-enabled devices.