Regulatory Recommendations for Decentralized Clinical Trials: Considerations for Implementation

Updated on February 25, 2023
Young scientist or tech holds liquid biological sample in gloved hands.

The last three years have catapulted the prevalence and demand of Decentralized clinical trials (DCTs), leaving contract research organizations (CROs) and sponsors scrambling to understand how to best implement and facilitate DCTs into their daily operations. With a 14.8% CAGR and a market value expected to reach almost 19 million by 2028, regulators such as the United Congress and the European Medicines Agency (EMA) have recently stepped in with recommendations on how to best manage decentralized elements of clinical trials, including the use of digital tools in decentralized procedures.

While decentralization might increase the accessibility of clinical trials to participants, it comes with new challenges that have to be carefully managed by CROs, vendors and patients. One unique challenge is managing investigational medicinal product (IMP) integrity. The EMA suggests that when sending IMPs to a participant’s home, it is essential for logistics providers and vendors to have a contract in place outlining how the product is handled and shipped. This is an area where the industry can improve and have better visibility and drug integrity. Additionally, while not considered a requirement, through digital solutions such as barcodes, logistics providers can verify that IMPs are dispensed at the appropriate time, ensuring that the correct product is used in the study and that the integrity of the product is maintained.

Similarly, the EMA has recommended that sponsors further consider the storage and administration of IMPs at the participant’s home when designing a DCT. Patients should have sufficient measures at home to ensure the IMP’s inclusion and exclusion criteria are adequately met. For example, appropriate storage conditions should consider temperature controls and unexpected light exposure. To maintain the safety and efficacy of a product, digital sensors can be used to monitor environmental indicators such as temperature, humidity, vibration, and light. If a patient does not have proper conditions to store a product, then local pharmacies can be utilized as an alternative to shipping the IMP directly to the patient’s home. In that case, the pharmacists should be trained to dispense the IMP using the correct protocol.

Decentralized Clinical Trials should also require drug-centric procedures that consider recall actions in case a return is necessary. If a drug is unexpectedly compromised, it is essential to have a plan for how IMPs will be collected. Real-time tracking can report precisely where IMPs are located until the product is delivered. Recording data is just one consideration to take into account when designing a study that involves proper recall procedures when administrating an IMP at a patient’s home. 

With this in mind, it is also essential to inform patients participating in the trial that third-party vendors will use their data to correctly and safely send an IMP to their homes. This information should be explicitly stated in the consent process, and participants should be made aware of their rights and any potential risks associated with using their data in this way.  

The EMA further recommends that healthcare professionals still be involved in preparing and administering an IMP, even in a decentralized setting. When a participant self-administers an IMP, there should be step-by-step instructions to ensure the correct and safe use of the product. In addition, electronic instructions via accessible methods, such as QR codes, should be considered.  

Other regulations, such as the recently passed Public Law 117-328, otherwise known as the 2023 omnibus appropriations bill, have recently gone one step further, no longer recommending certain procedures, but mandating clinical trials create diversity action plans. The outbreak of the pandemic accelerated the implementation of digital technology, resulting in a significant increase in the use of digital solutions including mobile health tools and tele-healthcare in clinical trials (e.g. video consultations), health data analytics (e.g. data processing systems that support bioinformatics modelling) and digital record systems.

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. The possibilities are virtually limitless, and in the context of trial participation and access to medicine technologies could assist:

  • Reduced assessment times and hence increased patient compliance
  • Improving access to individuals with rare diseases in remote settings
  • Reasonable adjustments to allow equal access for individuals with disabilities
  • Patient engagement from marginalized groups with a preference for remote access

It is critical for sponsors to work closely with regulators to ensure Decentralized clinical trials are conducted safely and in compliance. In the coming years, recommendations such as those posed in this article by EMA will further allow DCTs to advance, teaching sponsors lessons and benefits of this novel approach. Stabilizing guidelines and encouraging the use of digital tools will drive continued adoption and innovation.  

Neta Bendelac is Senior Director of Strategy at 4G Clinical.
Neta Bendelac

Neta Bendelac is Senior Director of Strategy at 4G Clinical.