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Phases of Clinical Trials, Preclinical and Clinical Phase 1, Phase 2, Phase 3, and Phase 4 Studies.Vaccine, FDA, NIDA Clinical Trials.
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Decentralized Clinical Trials

Decentralized clinical trials also termed as “direct-to-participant trials” “site-less” “remote” or “virtual” studies—are characterized by less dependence on traditional research facilities or specialist intermediaries for data collection. DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual healthcare interfaces, and direct delivery of study drugs and materials to patients’ homes. In a fully decentralized clinical trial, subject recruitment, delivery and administration of study medication, and acquisition of trial outcomes' data all proceed without involving in-person contact between the study team and the patient/subject.

Clinical Trials Transformation Initiative (CTTI) Recommendation Guidelines for DCTs;

  • A DCT does not have to be an all-or-nothing approach.
  • Engage with all stakeholders during the protocol design process.
  • A DCT will require some fit-for-purpose protocol design and conduct considerations.
  • Proactively address and map data flow, data storage, and associated procedures.
  • Streamline telemedicine implementation into clinical trials.

eCOA Clinical Trials

Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA employs technologies such as handheld devices, tablets, or the web to allow trial participants, physicians, and caregivers to directly report information related to healthcare outcomes. For example, trial participants or their caregivers may complete diaries or collect certain medical outcome information at home as a way to make participation more convenient.

Guidelines for eCOA Clinical Trials

In trials where participants live exclusively in the United States, all eCOA activity—ranging from participant-entered data to assessments recorded during telehealth visits, must be compliant with patient privacy regulations such as HIPAA (Health Insurance Portability and Accountability Act).

For trials that involve participants living in the European Union and United Kingdom, GDPR (The General Data Protection Regulation) is an even more strict set of regulations designed to keep all personal data (not only health-related information) of EU citizens private and secure.

GDPR equivalent regulations are now in place within Asia-Pacific countries as well.

Hybrid Clinical Trials

A hybrid trial is a clinical trial that includes both traditional and pragmatic clinical trial elements. It begins as a traditional clinical trial where participants are randomized to different intervention groups. Some of the data are collected using standardized procedure s and case report forms (CRFs) through protocol -defined visits. The remaining data are collected through routine health care visits via sources such as EHRs, medical claims, pharmacy databases, etc. This clinical trials design preserves the benefit of randomization, provides real-world outcome data while potentially accelerating product development and lowering the cost of data collection and patient follow-up.

Subtypes

Testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation.

Dual testing of clinical and implementation interventions/strategies.

Testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes.

Guidelines for Hybrid Clinical Trials

Data Quality and Relevance: One of the key elements to the success of hybrid designs that seek to collect RWD from routine health care practice is the relevance of the data to the question being addressed in the clinical trial.

Site Selection: Site selection is also critical for the success of hybrid trial s as a site’s EHR is one of the most important sources of RWD.

Assessment of EHR system includes whether critical data fields pertaining to the research questions to be answered including drug or vaccine exposure, clinical outcome and important covariates are present, and if not whether these variables can be algorithmically derived using existing data fields.

Assessment of an EHR system also includes checking the reliability of the system. Another consideration is the expandability of the site’s EHR system to add research data modules dedicated to the hybrid trial.

  • Randomization: The ability to randomize study participants is mandatory for the success of hybrid studies. This can be achieved through individual randomization, cluster randomization or cluster - Journal Pre-proof Journal Pre-proof crossover randomization.
  • Outcome Adjudication In hybrid trials, data from multiple sources may provide overlapping or even conflicting information. In some situations, data from several structured or non -structured fields need to be combined to determine a participant’s health status or disease outcome. Hence, it is necessary to have an independent adjudication committee to review selected data elements and determine the clinical outcome.
  • Blinding and Bias: An unbiased estimate of treatment effect is essential for the assessment of effectiveness of a new intervention, and every effort should be made to ensure an unbiased estimate is obtained.

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