Sarcouncil Journal of Applied Sciences Aims & Scope

Abstract: Over the past decades, there has been an acceleration of the Oncology Drug development with therapeutic breakthroughs that transformed patient outcomes, even though cancer continues to be a leading cause of mortality worldwide. The quality, accuracy, and compliance of clinical trial data must also be maintained at a high level in order to translate the laboratory findings to regulatory-approved therapies. Clinical data management forms the necessary basis that underlies regulatory filings, therapeutic approvals, and patient access to novel medicines. An example of this is a Phase III open-label, non-inferiority randomized trial that compared the study drug to sorafenib in unresectable hepatocellular carcinoma, where careful data management control throughout the study to regulatory submission has resulted in high-quality audit-ready datasets. On the same note, another trial, which is a Phase III randomised-blind, placebo-controlled trial of adjuvant nivolumab versus placebo in resected Stage IIB or IIC melanoma, exhibits complete data management leadership in the development of immunotherapy. The two trials highlight the fact that the Lead Project Data Manager position is not about doing work technically but also about strategic management, cross-functional interaction, vendor interactions, and the integrity of data security in the trial lifecycle. Effective implementation of these key trials sheds more light on the key leadership competencies such as strategic planning, risk management, stakeholder engagement, technical skills, and culture of quality development. Approval of lenvatinib to treat hepatocellular carcinoma and nivolumab to treat early-stage melanoma are the kind of breakthroughs that can be accomplished by excellence in clinical data management, both to rapidly translate scientific findings to life-prolonging treatments and to enhance societal confidence in clinical research.