After issuance of the final guidance document by FDA on Oversight Of Clinical Investigations - A Risk-based Approach to Monitoring, bio pharmaceuticals, medical device companies and CROs are actively embarking on this paradigm shift in clinical research to reap the benefits of risk-based monitoring (RBM). The correct identification of study-specific risks, their sources, categorisation and implementation of risk-based study-specific monitoring strategies, plans are the critical components in implementation of the RBM approach to ensuring high quality, integrity of data, and enhanced human subject protection.
One of the major challenges that biopharmaceuticals and medical device companies are facing nowadays is delay in getting their drug/device to market through a successful development programme. The most common reason for delays in clinical trials or development programmes is failure to recruit potential patients on a study as per the planned timeline. Patient recruitment timelines represent 22.3% of entire clinical development timelines
The last decade has seen information explosion in the field of molecular biology in cancer. The challenge is to translate this information and advance it into patient care. There are well trodden routes for translating new clinical information into drug therapy. However, translating new information into susceptible and specific diagnostic, predictive and prognostic tests are still in progress. Likewise, the information obtained from profiling of tumor molecules and markers to optimize therapy for individual patients is still underway. This review is a brief account of one such current technology involving tumor markers that help forecasting treatment response and prognosis in cancer medicine. In spite of tumor markers’ significance, the detection and analysis has been a challenging endeavor, and their potential not completely understood. Nevertheless, in the last few years, technological development has contributed an interest in the field.
The principal objective is to develop a methodology where it will be possible to address all the anticipated issues as at the beginning of the trial and as well as all unidentified issues which generally lands during the conduct and analysis of the study. Adoption of a strong study design planning is a must do impression in order to make the trial execution more effective. It helps to bridge between risk factors and outcome. A well established study design can reduce the systematic errors (Bias). Central importance of Clinical Trials based on their study designs by which the advantages outweigh the disadvantages of the errors those are the most frequent and common for maximum trial type. Prevalent errors which may prove to be vulnerable towards the achievement of specified goal of the study can be avoid by a robust planning and designing of the Clinical Study.
This paper describes about the challenges working with non‐CDASH designed CRF data while converting into SDTM domains at different stages such as identifying domains, annotating CRF, preparation of mapping specification and SAS Programming along with few examples. Based on the study design one can identify domains, annotate CRF and map them accordingly.
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