Real-world evidence is a hot topic in clinical research right now. But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.
Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.
The past several years have brought significant changes to the clinical trial landscape. Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.
With the age of remote clinical trials upon us, it bears asking: What do these trials mean for the common business-related tasks of clinical trials? One under-emphasized place of change will likely be investigator site budgets.
IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.
The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.
To some extent, the Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2) has come and gone without much fanfare. Perhaps that’s because prior guidance documents surrounding risk-based quality management practices stole its thunder, and sponsors, CROs, and investigators were already well on their way to finding ways to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results,” as advocated by ICH E6 (R2).
In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.
Payer receptivity to high orphan drug (OD) prices and, hence, revenue, will almost certainly begin to wane as budgets are increasingly strained by new therapies and as payers increasingly scrutinize the value of ODs. Indeed, there are signals that payers are becoming increasingly sensitive to the cost of newly approved ODs, even those that confer a clear clinical benefit to patients.
The clinical CRO market is defined as the combination of Phases 1 through 4 clinical activities, excluding discovery, preclinical, central laboratory, and post-approval/commercialization services. Within the $34 billion to $39 billion CRO market, the clinical CRO market alone is valued at $25 billion as of 2017, with an expected CAGR growth rate of 7 percent until 2020 (Figure 1). Almost 80 percent of the global CRO market revenue comes from the clinical CRO market.