Author: Natansh Modi
Modi, Natansh, 2024 Exploring the Value of Shared Clinical Trial Data: Policy, Application, and Impact, Flinders University, College of Medicine and Public Health
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Clinical trials are pivotal for the evolution of modern medicine, yet the full potential of clinical trial data remains unrealised due to industry-developed data sharing policies that restrict accessibility. This thesis advocates that the democratisation of data sharing practices - making clinical trial data broadly accessible to independent and qualified researchers - is not only important for advancing medical care but also fulfills a moral duty to honour the contributions of clinical trial participants.
Chapter 1 is the introduction that positions the thesis within a global context by discussing the role of data transparency in fostering trust and accountability in medical research. This chapter sets the stage for the thesis’s exploration of transparency issues across the pharmaceutical industry.
Chapter 2 audits the individual patient data (IPD) availability for anticancer medications, revealing low IPD transparency rates, especially for high revenue generating oncology medicines. This chapter raises questions about ethical obligations versus commercial interests.
Chapter 3 evaluates the transparency rates for clinical study reports and IPD in oncology within oncology and proposes actionable, evidence-based strategies to enhance data sharing practices, advocating for industry-wide reform.
Chapter 4 expands the scope to examine IPD transparency for the top revenue-generating drugs across all therapeutic categories, analysing whether oncology's data sharing issues are symptomatic of broader, industry-wide trends, potentially affecting other therapeutic areas.
Chapter 5, examines the pharmaceutical industry's 2013 commitments to transparency, juxtaposing them against current practices to identify gaps and propose essential updates fostering a culture of open data.
Chapter 6 moves to practical applications, detailing the creation of a predictive tool for neutropenia, a side effect of the anticancer drug Abemaciclib, using shared trial data to provide clinicians and patients with insights into differing risks and aiding personalised treatment decisions.
Chapter 7 examines the prognostic value of patient-reported outcomes (PROs) in advanced breast cancer, arguing that integrating PROs with clinical data could offer a more comprehensive approach to patient care, enhancing quality of life assessments alongside traditional metrics.
Chapter 8 synthesises the findings, offering a discussion of key insights, future directions, and the thesis's implications for global data sharing practices. It emphasises the need for ongoing collaboration between industry, regulatory agencies, and researchers to ensure clinical trial data serves its intended purpose.
Keywords: IPD, Data Transparency, CSR, Clinical Trial Data, Prediction Model, Patient-Reported Outcomes
Subject: Medical Science thesis
Thesis type: Doctor of Philosophy
Completed: 2024
School: College of Medicine and Public Health
Supervisor: Associate Professor Ashley Mark Hopkins