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.
The current late phase market in India is close to 60 million US Dollars which accounts for about 15 % of the total clinical research market. At present phase IV and Post Marketing Surveillance (PMS) studies mainly contribute to the late phase market in India. PMS market is likely to grow faster as DCGI is insisting to do PMS studies on new drugs, new biologics and follow-on biologics/biosimilars before or after launching in India.As health insurance is gaining wide acceptance, cost effectiveness and quality of life assessment studies like outcomes research is the new area which would gain momentum in few years.
“Targeting the right people in the right way will keep trial numbers high” Researches managing clinical trials will sight patient recruitment as their single most difficult barrier for meeting study timelines. According to center watch reports 45% of study delays are because of slow patient recruitment and on an average most delays exceed more than six months. Despite the prestudy promise of patients an estimated 30% of study site fail to recruit single subject.
Patient optimization, recruitment and retention, a key determinant of the success of a clinical trial, has always been a challenge. It is becoming more challenging with the increased complexity of clinical trial design, stringent eligibility criteria and the trend toward more targeted patient population. Considering importance of patient recruitment & retention in clinical trials to achieve the business objective but surprisingly, many companies do not dedicate any funds to this activity in the initial budgeting process. In fact, many companies do not plan for patient recruitment at all, believing that patient recruitment will happen some companies invest a lump sum to CROs, SMOs or sites and rely on them to recruit patients.
Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study (Questionnaire for planning Recruitment and retention).
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