Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?

When designing a trial there are three fundamental questions that must be asked for every study.

• What is the purpose and research question of the study (e.g., to show the treatment is safe or efficacious)?
• What data are needed to answer the research question?
• How will the data be captured?

Traditional and decentralized clinical trials start to divide with respect to how the data will be captured. Once it is clear what data are needed for the trial, conversations can start to determine the requirements for each procedure. What must be performed at a central facility? Can information be collected using mobile technology? Are local or home health care visits an option? Once these high-level requirements are determined, more time can be invested in determining which aspects of decentralization are most appropriate for a trial and how to operationalize the logistics of remote data collection and communication. Both the Clinical Trials Transformative Initiative and the Association of Clinical Research Organizations have released documents outlining recommendations and considerations for implementation of decentralized trials. Below is a high level summary of key recommendations and considerations during protocol development:

• Engage with stakeholders during the protocol development process. This can include FDA regulatory agencies, patients, clinical research organizations (CROs), and experienced third-party vendors providing services such as tele-health or home health care providers.
• Determine if additional requirements are needed to maintain protocol compliance. This can include the creation of updated work flows, additional trial-specific training, and supplemental/virtual education materials. For example, if consent is being captured remotely additional participant educations materials may be required.
• How will technological support be provided? Support will need to be available to trial participants, tele-health providers, home health care providers, etc. and may be handled by different entities such as the Sponsor, CRO, or a third-party vendor.
• How will data coming from multiple sources be handled? The data flow should be mapped to specify who the recipients of the data are and how data will be securely transferred. How will participant privacy be protected to ensure no personally identifying data are mishandled.
• Understand dispensing laws and regulations to ensure compliance if investigational medical product is being delivered directly to the participant.

The level of complexity in implementing a decentralized trial will largely be determined by the level of decentralization (e.g., a hybrid or fully decentralized trial). Meeting with experienced third-party vendors and CROs can provide a wealth of information when designing a protocol to better understand the best approach to collecting the required data for the trial. Diligent planning during protocol development will help ensure the reliability of the data required to answer the research questions of interest.

Heather Kopetskie, Director of Biostatistics, has over 16 years of experience in statistical planning, analysis, and reporting. She brings an extensive background of statistical and project leadership experience working on NIH and industry funded clinical trials in all phases of clinical development. Ms. Kopetskie has contributed to the publication of peer reviewed manuscripts and industry publications.