GBI Research, the leading business intelligence provider, has released its latest research, “Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management”. The report provides in-depth analysis of various strategies adopted for reducing the time and cost involved in clinical trials. The report analyzes the key factors which should be considered in efficient clinical trial processes. It gives a robust idea about how the application of technology can lead to time and cost efficient clinical trials.
Clinical trials are one of the most important parts of the drug development process. The various aspects involved in clinical trials such as implementation of technology, efficient supply chain management, proper site selection, patient recruitment, database management and others are important.
The Clinical Research Process – Clinical Development is one of the most time consuming stages so time efficient methods need to be incorporated
Clinical research is critical to the success of biopharmaceutical companies. Within it, the clinical trial is the most time consuming stage of drug development. Therefore, biopharmaceutical companies are focusing on ways to improve their efficiency of the clinical research process in order to maximize gains. This requires considerable investment from biopharmaceutical companies for the conduction of quality clinical trials.
Source: GBI Research
The above figure shows the step-by-step process for a drug to be developed along with the time-line to pass through all the phases of clinical research to reach the patient population. Clinical research is conducted in humans to verify if a new drug or therapy is safe and effective for treating a disease or condition. Clinical trials are conducted in different phases and on average it takes 12 to 14 years to discover and market one new drug. Pharmaceutical and biotechnology companies spend approximately $900m in bringing each new drug into the market.
Cost Saving Scenario in Electronic Data Capture (EDC) – Use of Electronic Method Leads to Reduction in Cost of Clinical Trial
Source: GBI Research, www.targethealth.com
If EDC is utilized in a multi center clinical trial study of 40 sites with 1,000 patients and 100 CRF’s, then potentially around $1.12m in cash could be saved. This clearly signifies that the EDC system should be implemented in order to reduce the cost of clinical trial.
Site Management Organizations (SMOs) – Reduces Study Timelines and Leads to Timely Completion of Clinical Trials
It has been observed that the use of SMOs leads to an overall reduction in study timelines. One of the characteristic factors responsible for this reduction in study timelines is the effective patient recruitment by SMOs. There is an improvement in pre-study planning and feasibility because SMOs are committed to the proper functioning of the clinical trial site. There is efficient communication among the subjects, Principal Investigator (PI), and sponsors which leads to improvement in patient retention and faith of patients on the trial. The ethics committee effectively deals with the region- specific ethical issues associated with the clinical trial.
ePRO (Electronic Patient Reported Outcomes) Reduces the Cost of Clinical Trials and Improves Data Quality
Use of ePRO instead of paper helps in improving patient compliance and quality of data which is gathered. By the use of ePRO the increase in patient compliance can improve by 97%. The acceptance of ePRO data by Food and Drug Administration (FDA) and European Medicines Agency (EMA) has led to an increase in its use. The choice of data collection method depends upon many factors such as number of patients, number of responses required, trial end point, and indication which is being studied. The choice of data collection method should lead to cost and time reduction without any compromises on the quality of data which is collected.
The initial cost of setting up ePRO is higher than the paper based method of data collection but the overall return on investment is larger. ePRO leads to long term reduction in the cost of data collection which is the reason why the majority of pharmaceutical companies are now switching to ePRO from the paper based data collection method. Cost reduction in clinical trials and thus in the overall drug development by ePRO is because of the increased patient compliance resulting in improved quality of data collected. ePRO helps in efficient data management by reviewing and verifying data.
If process mapped, by using ePRO solutions, a company would be able to save the cost of data entry, site monitoring, site review and data collection
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