AARDEX Group

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Introducing ‘Guidance for best
practices for clinical trials’ from the
World Health Organization.

On 24th September 2024, the World Health Organization (WHO) published ‘Guidance for best practices in clinical trials’ which provides the clearest direction yet on what stakeholders working within clinical trials should do to improve outcomes.

The guidance makes several recommendations. Firstly, patient, participant and community engagement are placed centrally in the trial planning and implementation phases. Secondly, trials in underrepresented populations such as children, pregnant women and older adults are better enabled and implemented. The guidance also details how trials should focus design and oversight on the key scientific and ethical considerations that determine whether trials are ethical, efficient and informative

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The clearest direction yet that Medication Adherence Solutions should be implemented to ensure optimised clinical trial outcomes.


This guidance responds to requests by the World Health
Assembly to the Director-General in resolution WHA75.8
(2022) on strengthening clinical trials. It aims to provide
the following…

  • High-quality evidence on health interventions to improve research quality and coordination
  • Identify and propose best practices and other measures to strengthen the global clinical trial ecosystem
  • Review existing guidance and develop new guidance as needed on best practices for clinical trials
  • Enhance clinical research efficiency and minimize research waste
  • Provide guidance on sustained clinical trials that are always functional and active for endemic conditions and can pivot in time of emergency or pandemics.

WHO cares. Regulators care. It’s now time you did


‘Automated and digital processes should be encouraged and supported globally to increase clinical trial speed, efficiency and transparency.’

But it isn’t just the WHO that cares. Medication adherence has increasingly become a focus for regulators. Indeed, the In US Food & Drug Administration (FDA) has targeted improvement around dose-selection strategies for oncology drugs through Project Optimus, an initiative of the Oncology Center of Excellence (OCE).

AARDEX is the only mature, robust and proven adherence solution on the market today, one that delivers the clarity, integrity and certainty you need to proceed with complete confidence in the exposure-response.

A library of resources designed to give you the hard evidence you need for your trial.

 

In this section you will helpful resources created to help you understand the WHO guidance, navigate the pathway to better adherence and deliver the hard evidence you need for your trial.

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WHO Cares.

It's now time you did

WHO Сares.

A pro-adherence strategy means little without the drive for better data quality

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Frequently Asked Questions

Given our extensive experience in the medication adherence field since 1984, it's safe to say that we've acquired a vast amount of knowledge on the topic. Listed below are the most commonly asked questions we receive, along with their respective answers.

Digital adherence monitoring refers to the use of technology to track dosing histories and improve medication adherence in clinical trials. This includes smart packages, smart drug dispenser devices, ingestible sensors, and mobile apps.

Adherence monitoring ensures that trial participants follow the protocol-specified dosing regimen, which is critical for accurate efficacy and safety assessments of the drug under investigation. Poor adherence can lead to unreliable trial results and regulatory challenges.

Common digital adherence technologies include:

a. Smart pill bottles and blister packs with sensors

b. Electronic drug delivery devices, like smart injectables or smart inhalers

c. Ingestible sensors embedded in medication

d. Mobile health apps for patient self-reporting (e-diaries)

While all methods aim to track dosing histories in real time, they differ significantly in data teness. In general, the closer a method is to the actual act of medication intake and the less effort it demands from patients (i.e., more passive approaches), the more accurate and robust the adherence data.

By providing real-time data on medication use, they help:

a. Detect and address non-adherence early

b. Improve patient engagement and retention

c. Reduce trial costs by preventing data loss due to non-compliance

d. Enhance the accuracy of trial results

Digital adherence monitoring should comply with:

a. ICH Good Clinical Practice (GCP) guidelines for trial integrity

b. FDA and EMA regulations on digital health technologies

c. WHO guidance on best practices for clinical trials

d. Data privacy laws (e.g., GDPR, HIPAA)

Patients are key stakeholders in digital adherence monitoring. Their engagement is essential for the success of adherence monitoring. Educating participants on how and why adherence tracking benefits them can improve compliance and trust in the technology.

Adherence data is gathered either in real-time or at scheduled intervals. Using advanced analytics and AI, patterns can be identified, non-adherence flagged, and valuable insights generated to support informed decision-making for all stakeholders, including patients, investigators, study managers, and sponsors.

Clinical trials using digital adherence monitoring must comply with strict data protection regulations. Encryption, anonymization, and secure data storage are commonly used to protect patient information.

Advancements in technology will continue to make adherence tracking more seamless, patient-friendly, and cost-effective. As digital monitoring evolves, it is expected to become a standard tool for remotely assessing appropriate drug exposure in modern clinical trials.

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Schedule Meeting with our Adherence Expert

Having co-authored over one hundred peer reviewed papers alongside mentoring trial sponsors on medication adherence, our Scientific Lead, Bernard Vrijens, is considered an expert in the field.

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