Legal and Regulatory Considerations to Implement Decentralized Clinical Trials

The benefits of Decentralized Clinical Trials (DCTs) are many. These trials reduce the burden of research on participants through the power of technology. DCTs also maintain patient safety, maintain data quality and integrity, increase access to care, and may lead to better research outcomes. They represent a more efficient manner of implementing trials in the clinical research enterprise globally.

Key Highlights

With Decentralized Clinical Trials (DCTs) becoming more prevalent, so have the initiatives, recommendations, and regulations. Read about what to consider when implementing DCTs.

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Dr. Isaac Rodriguez-Chavez
Dr. Isaac Rodriguez-Chavez
SVP, Scientific & Clinical Affairs

Increasing trends in clinical research point at a paradigm shift from brick-and-mortar-centric activities in traditional clinical trials to trial participant-centric activities in DCTs. Trial participant-centric activities leverage telehealth, communication platforms, digital health technologies (wearable devices), standard health care systems, and other approaches to maintain trial participants in their ecosystems.

Important benefits of DCTs have been described, including the potential for faster recruitment of trial participants, improved participant retention, a greater measure of control, convenience and comfort for participants, and increased diversity among the participant pool.

However, as with any innovation in the clinical research field, there are regulatory and legal matters that must be addressed before a DCT can begin.

Considerations for Decentralized Clinical Trials

Recently, considerations have been published surrounding legal and regulatory considerations that sponsors should address when conducting DCTs. The primary set of considerations cover a range of topics, from remotely informed consent, participant identity verification, and the shipping of products across the United States and in different countries.

In the United States, state-level laws may present legal barriers for DCTs. Some states require licensure of supervising physicians to practice medicine in the participants' states. Other states do not allow the shipment of products directly to trial participants—and within states that do allow this, receipt and accountability for these products may present logistical complexities.

Several suggested solutions have been developed. To start, sponsors should review and understand the individual, state-level laws that govern clinical trials, medical practice, investigational medical practice distribution, and telemedicine in the United States. From there, identification of physicians with medical licenses in multiple states, clarifying where laws are standardized between states, and simplifying trial processes where necessary may ensure that trials aren’t paused due to legal matters. Similar legal and regulatory principles apply when implementing DCTs in different countries.

This is because compliance with local and country laws and regulations is paramount for the successful conduct of DCTs globally.

Learn more about the regulatory considerations for other areas of clinical research

Data and Privacy

Data privacy and security are of the utmost importance where personal health information is concerned. The advent of digital health technologies outside of the clinical trial landscape set off a chain reaction in the modernization of standards for “privacy, safety, ethics, and regulation.”

In DCTs, where data is being transmitted across countries, protecting personal health data from breaches is even more paramount. Data similar to GPS location records might put trial participants “at particular risk for legal actions and economic loss due to stigma.”

Privacy concerns are directly tied to recent developments in privacy laws. These laws require even more explicit participant consent and “set a higher bar for data to be considered ‘de-identified.’” DCT sponsors must adhere to these more complex laws when operating in areas governed by them.

Regulatory Considerations

As with traditional clinical trials, DCTs may collect large amounts of high-quality data. For instance, while many trials have pivoted to digital, there are still regulatory considerations that should be addressed regarding the submission of digital endpoints in all clinical investigations, including Phase III DCTs. The COVID-19 pandemic, however, has required quick adaptation by regulatory agencies to determine how digital endpoints are acceptable clinical outcome measures.

The quality and integrity of data obtained in DCTs are also key regulatory considerations for the successful implementation of these trials. Digital data may be stored and transferred in multiple electronic systems owned by different stakeholders. Mapping data transference is an equally important regulatory matter as data verification, validation, and original source should be carefully established in DCTs. Another key regulatory element of consideration is the obligation to maintain data privacy and the confidentiality of trial participants as described above.

The use of mobile healthcare providers, rather than trial-specific staff, represents another regulatory consideration. Sponsors should make sure that these mobile providers are qualified for all tasks required of them—which may include clinical assessments, laboratory blood draws, administration of products or other treatments, participant education, and in-home compliance checks. Again, this further ensures that the data collected is of the highest quality and not compromised by unsuitable practices.

Regardless of trial type, it’s important to remember that DCTs should be held to the same standards as traditional clinical trials. All ethical, Good Clinical Practice (GCP), legal, and regulatory requirements apply to this type of research, and all DCT protocols must be adhered including all remote activities led by DCT sites. Although regulatory bodies are still working to meet this paradigm shift—particularly in the face of the COVID-19 pandemic accelerating the pivot to a DCT model—the legal and regulatory future for clinical trials remains optimistic.

We’re reducing the burden of research on the trial participant—regardless of their race, gender, socioeconomic status, or ethnicity—through the use of communication and digital health technologies.

Learn about our expertise on DCTs

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