 The research and development (R&D) cost for a new drug in the United States has reached $2.3 billion on average. The ever-rising costs of bringing a new drug to market present a significant challenge to pharmaceutical companies for a return on investment (ROI). Drug companies may end up passing costs on to patients.
The size, scope, and length of clinical research significantly impact R&D expenses. The larger and more complex the trial, the more resources it needs to accommodate personnel, participants, equipment, and facilities. Conducting a rigorous feasibility study before commencing trials includes only the necessary procedures. A study should also discover operational requirements, such as patient identification and recruitment. Participant recruitment accounts for up to 40 percent of the clinical trial budget. Poor patient identification results in a high dropout rate. Three in 10 patients quit the trial mid-way, increasing R&D costs further. Being upfront about the goal of the clinical trial and what is required of participants increases transparency. Sharing as much information as possible raises participant awareness, helping attract and retain participants. Working with a patient recruitment service provider who puts patients first also helps lower dropout rates. A lack of compliance can also increase R&D expenses significantly by delaying approvals. Creating a detailed compliance plan is not enough. Drug manufacturers must also anticipate potential pitfalls and have contingency plans, such as backup participants to replace those who fail requirements. Training personnel on their obligations and regulatory requirements ensures that everyone sticks to the design protocol. As a drug trial enters Phase 4, the study may move to a global level, which can be another source of expensive logistical problems. Transportation for personnel, products, and equipment costs rise. At this point, researchers must decide how to navigate the resultant costs. Prior studies may also offer insights. Some trial destinations, like New Zealand and Australia, are economically friendly. Destination-specific factors that significantly impact trial costs include local infrastructure, regulations, and availability of qualified personnel. Researchers may recruit various vendors for support. Service providers may include IT specialists and recruitment and marketing personnel. The lower the headcount for operations, the lower the costs. Working with a vendor that offers more than one required service may be more cost-effective than contracting two separate service providers. For example, hiring a firm that can recruit patients, educate them, and market the drug may be cheaper than hiring three separate vendors. Also, hiring easy-to-use, easy-to-set-up vendor services also helps eliminate waste and time delays due to redundancies or tech friction. A detailed feasibility study does not guarantee cost-effectiveness or budget predictability. Regular reviews are the key to staying on budget and schedule. Reviews may reveal unnecessary steps and personnel. Monitoring and evaluating operations also allow for cost-benefit analysis. However, reviewing operations is not enough. Drug companies must have plans to improve them. Process improvement can streamline operations by cutting inefficiencies and enhancing accuracy, reliability, patient safety, and research outcomes. Not all drivers of high R&D costs are within the control of pharmaceutical companies. However, avoiding overly complex design protocols and unnecessary procedures that might needlessly prolong the study helps prevent waste and delays.
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