Overcoming Barriers for Use of Real-World Evidence Among Payers, Drug Manufacturers


The certification of data could lead to widespread use of real-world evidence regarding the efficacy of drugs in clinical trials.

The standardization of real-world evidence (RWE) from observational studies could potentially benefit drug manufacturers and payers, according to a recent study.

The importance of randomized clinical trials (RTCs) has come under scrutiny recently due to the fact that most trials cannot provide RWE that includes data such as long-term outcomes, comparisons to other treatments, and utilization.

RTCs also typically do not include cost-benefit analyses that outline the benefit-risk balance and value, which both patients and payers value, according to the study published by the Journal of Managed Care and Specialty Pharmacy. A potential barrier for implementing RWE is that payers who collect data from studies conducted by manufacturers feel that there may be a conflict of interest, such as a financial incentive, the researchers noted.

Payers also expressed concern that data from observational studies will not apply to their customer base. Skepticism can be increased through study methods such as pragmatic or adaptive trial designs, combining results using Bayesian methods, using retrospective cohort designs, or using electronic health records that require adjustments, according to the study.

Due to increased interest in RWE, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) created a Real-World Data Task Force that created a report outlining the different methodological considerations for researchers looking to create studies that measure RWE. The task force also expressed a need for additional organizations to analyze evidence from observational studies in health technology assessments, which also include information from clinical trials.

However, researchers in the current study are proposing a “seal of approval” process that suggests transparency would be effective for verifying the accuracy of data, especially for studies conducted by manufacturers. Through submitting the results of a study for review and certification by qualified independent organizations, researchers believe it could facilitate payer use of manufacturer-generated RWE.

These third party organizations could review the studies and confirm that they meet requirements, thus creating valid and unbiased results payers can trust. Researchers also suggest this process should be voluntary and not required for all RWE studies.

Although this is a potential way to overcome the barriers of accurate RWE, the implementation of a certification process comes with some barriers as well. The most significant barrier is a third party organization reviewing the observational studies, according to the study.

This organization must be credible, knowledgeable, and impartial so their results can be trusted by payers. Researchers also identified streamlining the process of certification to make it timely so that more manufacturers will submit their studies for review, and do not deem it to be a waste of valuable time.

Other issues such as creating examples to demonstrate the process, and funding could potentially be barriers for this process. With certifications, researchers can trust the studies provided for the drugs they consider adding to their formularies and manufacturers can benefit from payer acceptance of their studies, the researchers concluded.

Certifications for RWE data from observational studies have the potential to create a more standardized process for RWE and could be valuable for manufacturers and payers alike, the study concluded.

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