Rise of decentralized clinical trials

When the COVID-19 pandemic sent countries and communities into lockdown, one of the most severely impacted areas of healthcare was clinical studies. To safeguard patients and researchers, medical centers were forced to temporarily shut down many clinical trials.

According to one study, there was a substantial decline in the number of U.S.-based studies initiated between February 2020 and May 2020. While the drop in the number of new studies was less severe in non-US-based studies, there was also a sizeable reduction.

Even before the pandemic, however, there have long been challenges with the traditional clinical trial model, with an Institute of Medicine report noting that as many as 75 percent of investigators are unable to enroll the target number of patients.

With trials forced to adjust for COVID-19, the move to decentralized clinical trials (DCTs) has gained momentum. Over the past 18 months, the industry has witnessed a rapid uptake of DCTs and a willingness to embrace digital solutions to support patient-investigator interaction.

A tighter regulatory framework

Integral to supporting DCTs is a regulatory framework that harmonizes rules for conducting clinical trials and that simplifies and centralizes the way submission data and other clinical trial information is sent and received.

This is the objective behind European Regulation n. 536/2014 (better known as the Clinical Trials Regulation) and the Clinical Trials Information System (CTIS). The health authority has also issued strategic goals for regulatory science to 2025, including a commitment to further develop the regulatory framework for emerging clinical trial data generation, including modernizing good clinical practice oversight to support DCTs, improve access and participation in such trials, and develop the capability to assess complex datasets captured by wearables and other similar technology.

Ultimately, the goal is to ensure Europe retains and expands its competitiveness when it comes to carrying out clinical trials, and ensuring high quality standards that place the patient at the center.

EMA Support to DCTs

When the new Clinical Trials Regulation comes into force on January 31, 2022, the CTIS will become the single-entry point for the submission and supervision of clinical trials in the European Economic Area (EEA), comprising the EU and Iceland, Liechtenstein and Norway.

It will encompass the EU portal and the EU database for clinical trials, and will interact with various systems such as the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the International Clinical Trials Registry Platform (ICTRP), the World Health Organization platform.

The CTIS will allow sponsors to:

–      Request a clinical trial in up to 30 EU / EEA countries with a single request

–        Facilitate the involvement of trial participants, allowing easy expansion of trials to other EU / EEA countries

–      Collaborate between countries to achieve better results and share knowledge

–      Ensure that more publications and clinical studies are conducted in the EU/EEA for greater

competitiveness of Europe.

(Learn more about the CTIS and how it will be used)

DCTs Win Clinician Support

As more and more clinical research professionals and pharmaceutical companies embrace DCTs, the wider healthcare industry has quickly adapted and responded. Hospitals and doctors are already developing and organizing pilot projects aimed at assisting and monitoring patients enrolled in clinical trials outside the hospital.

The goal is to identify quality measures to ensure continuous care, providing the enrolled patient with medical devices for reading certain parameters (e.g. heart rate) or applications that allow the patient to update the doctor on the progress of the therapy, ensuring ongoing support for the patient. At the same time, it has increasingly been shown that DCTs help to address many unmet patient needs, such as easier access to clinical trials, less travel, and a better overall experience.

Since the start of the pandemic, telemedicine has become far more widely used. Its benefits to both healthcare providers and patients are apparent – it allows  for more agile and effective continuity of care and remote clinical monitoring in total safety, more homogeneous treatment, less bureaucracy, and greater regional hospital integration.

The role of the pharmacist is also changed by DCTs. Broadly speaking, hospital pharmacists are important intermediaries in clinical studies, providing their expertise in medicines, pharmacotherapy and pharmacokinetics during scientific research. With the rise of DCTs, pharmacists could also prove to be strategic supervisors during clinical research by helping to manage more complex health assessments for patients, rather than requiring trial participants to visit less easy-to-access research clinics.

Progressing clinical research

With so many clinical trials failing to recruit enough patients, resulting in delays to studies, the move to better harmonize the clinical trial process in Europe through the new CTR, combined with growing acceptance of DCTs, could prove to be transformational. The EMA is committed to fostering innovation and research. Greater transparency, a more streamlined process, and a more patient-centric approach are all key to achieving this goal.

On January 31, 2022, when the new Clinical Trials Regulation comes into force, the Clinical Trials Information System (CTIS) will become the single-entry point for the submission and supervision of clinical trials in the EEA. The CTIS will be used for the submission of the initial application of the CTA (Clinical Trail Application) dossier by the sponsor. The procedure will be divided into:

–      Validation phase: (takes place in 10 calendar days)

–      Evaluation phase: (divided into two steps of 45 calendar days each: coordinated assessment and national evaluation)

–      Final decision: (takes place in 5 calendar days through a joint evaluation of the Member States and sent with a notification to the sponsor through the EU Portal).

This procedure permits:

• Harmonization of the documents (protocol, investigator’s brochure, the Investigational Medicinal Product Dossie, risk/benefit)
• Specific timeline
• Nomination of a Reference National Competent Authority to lead the assessment and collect the comments of the other NCAs involved
• Coordinated assessment of the CTA, thus leading to a single harmonized decision among the Member States involved
• A fast-track national authorization.

Only the studies that have received the final decision will be able to be published.

EMA will make the clinical trial application form and supporting dossiers stored in CTIS publicly available. The CTIS system will:

• Support the day-to-day business processes of member states and sponsors throughout the lifecycle of a clinical trial in a user-friendly way
• Provide regulatory oversight of clinical trials and tools for supervision and monitoring
• Contain collaboration tools as well as workflow and document management capabilities accessible via individual workspaces, the Sponsor Workspace and the Authority Workspace. The Sponsor Workspace will assist companies that run clinical trials to prepare and compile data to submit to the system for assessment by member states; the Authority Workspace will support the activities of member states and the EC in overseeing clinical trials
• Enable members of the public to access detailed information on all clinical trials conducted in the EU, in all official EU languages, through a dedicated Public Website.