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Related Concept Videos

Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Bioequivalence studies: Biowaivers01:13

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Related Experiment Video

Updated: Apr 6, 2026

Visualizing Field Data Collection Procedures of Exposure and Biomarker Assessments for the Household Air Pollution Intervention Network Trial in India
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Decentralised clinical trials in India: Stakeholders' perspectives.

Arghya Biswas1, Jeroze Dalal2

  • 1Department of Clinical Research, Texila American University, Guyana, South America.

The Indian Journal of Medical Research
|April 4, 2026
PubMed
Summary

Decentralised clinical trials, particularly hybrid models, are gaining traction in India, improving patient convenience and diversity. However, limited digital literacy and regulatory uncertainty pose challenges to wider adoption.

Keywords:
Decentralised clinical trialsDigital healthIndiaPatient-centric researchRegulatory complianceTelemedicine

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Area of Science:

  • Clinical Research
  • Digital Health
  • Health Services Research

Background:

  • Decentralised clinical trials (DCTs) utilize digital technologies to improve accessibility and efficiency in research.
  • This study focuses on the adoption of DCTs among Indian clinical research professionals.

Purpose of the Study:

  • To assess the adoption, perceived benefits, and challenges of decentralised clinical trials in India.
  • To understand patient satisfaction and future expectations regarding DCTs.

Main Methods:

  • Sub-analysis of a global cross-sectional survey (n=288) involving 47 Indian site professionals.
  • Data collected on roles, trial types, therapeutic areas, benefits, challenges, and patient satisfaction.
  • Descriptive statistics, weighted averages, and mean rank analysis were employed.

Main Results:

  • Hybrid trials (71%) were more common than fully decentralized trials (29%).
  • Home health visits and remote monitoring were frequently adopted components, especially in oncology and cardiovascular trials.
  • Key benefits included improved patient convenience (3.8) and diversity (3.5); challenges included limited digital literacy (2.3) and regulatory uncertainty (6.1).
  • Patient satisfaction averaged 4.0, with 83% expecting continued growth in hybrid trial adoption.

Conclusions:

  • Hybrid DCTs show potential for enhancing inclusivity and efficiency in India, particularly for non-communicable diseases.
  • Gaps in digital literacy and regulatory clarity impede the scale-up of DCTs.
  • Strategic investments in training, infrastructure, and regulatory frameworks are essential for maximizing DCT potential.