A recent publication in JAMA on 1st July 2024, the Pharmaceutical Research that underwent at the FDA and Philadelphia-based University of Pennsylvania disclosed the role of payers in clinical trials. The statement disclosed that the closer collaboration between healthcare payers and researchers will not only ease the drug development process but also boost Medical Research Partnerships. Citing the statement, it was also disclosed that the collaboration will result in better healthcare policy coverage and leverage a positive impact on patient outcomes.
According to the FDA reports, insurance providers in research can play a key role in clinical trial funding. Let us look into the 5 main aspects of how payers in clinical trials can play a major role under the FDA Guidelines.
Top 5 Roles of The Payers in Clinical Trials As Per FDA Guidelines
1. Cost Reduction
The first reason how the collaboration between health insurance and clinical trials can be beneficial in clinical trial funding is the reduction in costs. Primarily, it is seen that the manufacturers that undergo designing and conducting the clinical trials are often required to consider how a drug can reduce certain costs and improve healthcare services. Fortunately, this probably will not involve a slew of new endpoints but rather a different way of looking at existing endpoints.
For example, if a manufacturer of a lipid-lowering medication is analyzing the impact on the incidence of myocardial infarction (MI), the trial readout may include how many MIs occurred in each arm of the trial and compare them for statistical significance. For the cost-savings analysis, trial investigators may recruit the services of a healthcare economist who could research the mean costs of hospitalization due to MI as well as supportive care medications.
Considering this, the length of hospital stay and associated emergency department (ED) costs are also valuable. However, if there is a collaboration between health insurance and clinical trials, the manufacturer can get the opportunity to discuss the trial data in both clinical and financial terms and this will ease the drug development process.
2. Trackable Endpoints and Trial Funding
The second reason for how payers in clinical trials can play a major role in clinical trial funding is to set up certain trackable endpoints. Majorly, it is seen that the manufacturers often present the patient outcomes to the healthcare payers that may not be trackable by them.
For example, patient outcomes like ACR20 response in a rheumatoid arthritis trial or an improved HbA1c in a diabetes trial may be sufficient for the FDA, but such endpoints rarely show up in a health plan’s data set. While the primary endpoint of a clinical trial will always need to follow FDA Guidelines. Citing this, if there is a Medical Research Partnership between health insurance and clinical trials, the healthcare payers would be guiding the manufacturers to include secondary or exploratory endpoints that payers can review in their data.
This, as a result, will boost clinical trial funding and lead to the use of healthcare resources such as hospitalizations or visits to the ED or clinic. Enforcing this, the drug development process will get smoother and will help the patients avoid the use of certain supportive or chronic drugs. This will help the healthcare payers to estimate the savings and strengthen the value message of the data leading to a boost in overall value.
3. Driving Long-Term Data
The third reason for how payers in clinical trials can play a major role in clinical trial funding is to boost the long-term data. Primarily, the clinical trials are designed for the shortest duration to save money and get the drug to market. However, healthcare payers hesitate to adopt new medications for the patients as the data lack long-term value.
If there is a collaboration between health insurance and clinical trials, the healthcare payers can help the manufacturers plan long-term analyses that will enhance the pivotal clinical trials. This will lead to the development of a publication plan to communicate these long-term results. This is especially important for new cell-based and gene therapies, where healthcare payers face high upfront. By helping the manufacturers get long-term data, the healthcare payers can better assess the drug’s value, and boost clinical trial funding and cost savings over time.
4. Integrating Quality Measures
The fourth reason for how payers in clinical trials can play a major role in clinical trial funding is the boost in the quality measures by focusing on endpoints. Primarily, as the healthcare market is focusing on Value-Based Care, the significance of quality measures has increased. While not all diseases have associated quality measures, clinical trial designers should review the quality metrics relevant to the study’s disease when selecting endpoints.
For instance, a drug that reduces re-hospitalization rates can improve the quality scores of a health plan or IDN, making the medication more appealing to healthcare payers. By aligning trial endpoints with these quality measures, payers can help to ensure the data generated is both valuable and actionable and boost patient outcomes.
5. Bridging Real-World Applicability
The fifth reason for how payers in clinical trials can play a major role in clinical trial funding is to increase real-world applicability by bridging the gap between controlled trial settings and everyday patient experiences. While clinical trials follow strict FDA guidelines and involve a selective population, the broader, real-world population often presents more variability in response, safety, and adherence. Insurance providers, being key stakeholders in the drug development process, can assist in several ways.
Firstly, payers can work with manufacturers to ensure that the trial populations closely resemble real-world patient demographics. This can be achieved by selecting more diverse participants and considering common patterns during the trial design phase. Secondly, payers can help manufacturers develop a robust real-world evidence (RWE) strategy that continues beyond the initial trial phase. This involves collecting and analyzing data from the broader patient population once the drug is marketed, including post-market surveillance and real-world studies that provide ongoing insights into the drug’s performance.
Lastly, healthcare payers can support the development of publication plans to communicate real-world findings to health plan customers, ensuring that the real-world experience of a drug is well-documented and available for review. This helps build confidence in the drug’s efficacy and safety, aligning with FDA guidelines and the overall drug development process.
Conclusion | Role of Payers in Clinical Trials
In conclusion, payers in clinical trials can play a key role in the drug development process and clinical trial funding. Abiding by the FDA guidelines and closer collaboration between health insurance and clinical trials can significantly benefit the healthcare sector and boost Medical Research Partnerships and patient outcomes.
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FAQs on Crucial Role of Payers in Clinical Trials
1. How do payers contribute to cost avoidance in clinical trials?
Ans. Payers help manufacturers reduce costs by discussing trial data in both clinical and financial terms. This collaboration allows for a comprehensive analysis of cost savings related to healthcare services, such as hospitalization and supportive care, improving the efficiency of drug development
2. What role do payers play in setting trackable endpoints for clinical trials?
Ans. Payers guide manufacturers to include secondary or exploratory endpoints that are relevant to healthcare payers and can be tracked in their data. This ensures that trial outcomes are valuable for both regulatory approval and practical healthcare application, thereby enhancing clinical trial funding.
3. Why is long-term data important in clinical trials, and how can payers help?
Ans. Long-term data is crucial for healthcare payers to assess the sustained value of new medications. Payers can collaborate with manufacturers to plan extended analyses and develop publication plans, providing a better understanding of the drug’s long-term benefits and improving clinical trial funding and patient outcomes.