Three Ways to Reduce Cost and Complexity in Clinical Trials
Medicine research and clinical trials are crucial to the success and growth of healthcare industry. However, it is also the segment that faces varied economic challenges and fluctuations. Furthermore, the looming expiry of their products’ patents keeps the industry constantly on its toes and work on its operational efficiency to survive and grow.
Clinical Trials – The Cost Factor!
Clinical trials are one of the largest cost drivers in the healthcare industry. These trials are sponsored by healthcare and/ or biotech companies. According to an article published on clinical trials arena in 2018, “the average cost of moving from phase 1 to phase 3 is over $79.1 million and is as high as $52.9 million for single phase 3.” This cost may go up anytime due to various factors and it impacts the performance of the industry in a big way. Hence, it is imperative to work on cost control strategies for clinical trials.
Factors to be considered:
- Streching timeline
Delays affect clinical trial budgets to a great extend and can be financially damaging too. One of the most common reasons for delays in clinical trials is patient recruitment and retention, which is quite a complicated and tough aspect of the trial. A research claims, “69% of patients final pre-screening, 58% decline consent and 8% drop out after the enrolment.” Researchers are adopting a patient-centric approach, wherein, patients’ point of view is considered. The approach would aid in patient recruitment and retention and control the delays in trial. It also emphasizes on the importance of site selection.
- Logistics Decisions
Most of the clinical trials in phase 3or 4 are conducted on a large scale at a global level. And hence logistics cost comes into the picture. More often than not, the product shipment decisions are based more on previous experiences and less on the feasibility of the site. It is best to take a pragmatic approach to it and analyze if it would be feasible to ship the product to clinical site directly or make sense to have a local depot there. Prior study may be factored in, although may have less or zero relevance to a new trial. Instead, a study must be conducted on demand and supply for the site and the logistics and operational costs must be evaluated before deciding.
- Interactive Response Technology (IRT)
Automating the processes through IRT can bring down the costs significantly. It reduces manual oversights, the risks of stock outages and aids in supply management. IRT systems can be programmed to monitor depot inventories, batch expiries and keep supply managers updated about the it through alerts. IRTs can be custom-built to provide real-time feed on varied aspects of operations in clinical trials including stocks, supply-chain, shipment, etc. This small investment can optimize the operations greatly and aid in cost control. It also simplifies the entire complexity of the tedious processes.
Cost control and increasing operational efficacies are the key to profitability of any clinical trial. And there are several opportunities to pursue this goal. A tactical approach and its successful execution would mean saving millions of dollars and improved worth of the drug in investigation.
Current Outlook of Clinical Research in India
India is rapidly gaining acceptance globally as the go-to destination for clinical research. The country offers the advantages of having experienced personnel, good infrastructure such as well-equipped hospitals and laboratories, and a diverse patient pool. Moreover, the increase in life expectancy rate to 65 years and above gives rise to a host of lifestyle diseases such as diabetes, hypertension, neurodegenerative diseases and more, paving way for many multinational pharmaceutical companies to invest in clinical trials in India. Apart from this, cost effectiveness is an important factor that drives outsourcing of clinical trials to India.
The recent amendment made by the Ministry of Health and Family Welfare, Government of India, to the regulatory laws (New Drugs and Clinical Trials Rules, 2019) was with the aim of increasing the percentage of clinical trials conducted in India that hit an all-time low in the period between 2011 and 2013. In a bid to streamline approval processes, well-defined timelines have been introduced. The new rules have shortened the approval timeline for clinical trials of drugs manufactured outside India to 90 days. For drugs manufactured in India, the clinical approval timeline is 30 days. Pre-submission and post-submission meetings between the sponsor and the Drugs Controller General of India (DCGI) are attempts to increase transparency in all dealings related to the clinical trial. In addition, the non-refundability clause of the compensation package was removed as this was seen as a major deterrent for international companies, especially if a death/injury was proved to be unrelated to the trial at later stages. Apart from clinical trials, there has been a boom in the field of data management and medical writing with a number of homegrown clinical research organizations (CROs) demonstrating expertise to handle end-to-end services for sponsor companies.
Last but not the least, concerted efforts and joint participation of the Indian government and Indian pharmaceutical companies in policy-making decisions and prioritization of patient’s safety and health will build confidence in international companies about India’s capability in contributing to the clinical research industry.