Bringing Clinical Trials to Patients: ACRO Decentralized Clinical Trials Working Party

Clinical trials play a vital role in the development of new therapies for patients that need them. Traditionally, trial activities have been centered around trial sites, the locations where patients receive treatments and are evaluated to determine the safety and efficacy of the intervention. Traditional clinical trials require patient travel, which may be time-consuming, inconvenient, or costly, and could restrict access for individuals who live far away from a trial site, have limited mobility, or cannot spare the time away from work. Any unnecessary burden on patients could make it difficult to enroll and retain a sufficient number of participants in the trial.

Innovations in clinical trial design are leveraging emerging mobile technologies and increased connectivity to transcend some limitations of conventional trials by incorporating decentralized, patient-centric approaches. With digital capabilities such as wearable devices, telemedicine, and real time data collection, it is now possible for patients to participate in trials and be monitored remotely. This allows patients to be included in trials from different geographies and from groups that are typically under-represented in clinical trials. 

Despite clear benefits to patients, gains in efficiency and general acceleration of treatment development, there has been a lack or slow adoption of this decentralized approach. Feedback from industry highlighted multi-faceted reasons for this, including the risk averse nature of sponsors to deviate from the traditional conventional trial models. Overwhelmingly, it was considered that there was a lack of end-to-end guidance on decentralized trials that could mitigate this. 

As a result, last year the Association of Clinical Research Organisations (ACRO) established the ACRO Decentralized Clinical Trials Working Party (ACRO DCT WP), which has paved the way to examine the detailed end-to-end process and unique benefits and challenges of decentralized clinical trials (DCTs) with the aim of creating tools for industry to support and mitigate the uncertainty around creating and implementing DCTs. 

ACRO DCT WP, chaired by Medidata, is a collaboration of global clinical research and technology companies and experts in general DCT innovation, patient-centric approaches, international regulations, operational clinical trial process, data management, and technology. The group has worked to compare and contrast the lifecycle of a DCT with that of a traditional clinical trial in order to illustrate what a traditional clinical trial and a DCT share in common. 

The team has since released a white paper titled “Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework” and an accompanying toolkit. These provide a set of operational best practices for the implementation of decentralized clinical trials that will be helpful to sponsors and research organizations as the industry increasingly sees technology-enabled trials.

The toolkit consists of: 

• Bringing the trial to the patient: A Quality by Design Manual for Decentralized Clinical Trials which compares a conventional trial with a DCT to examine unique aspects and provide a framework for quality each step of the way.
• A Decentralized Clinical Trials Risk Assessment Considerations Spreadsheet which aims to complement (not replace) organizations’ current risk assessment tools.

The COVID-19 pandemic has further highlighted the value and necessity of elements of DCTs. Now, a set of general principles is available to guide effective, patient-centric planning and execution. Where appropriate, decentralized trials are providing a way to continue to treat patients and to keep clinical trials running despite site access limitations during the pandemic.

Throughout this initiative, the working party received consistent support and feedback from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Research Authority (HRA), as well as significant contributions from the ACRO DCT WP members. To date, the group has focused on the UK clinical trial process and the ACRO DCT WP is now looking to carry out the same initiative in collaboration with other countries’ healthcare authorities.

Read the full white paper, Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework.

This blog was authored by Fiona Maini, global compliance and strategy principal at Medidata. Fiona focuses on the evaluation of relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the life science and healthcare industries.