Intriguing partnerships have made big headlines this year. Retail giant Amazon bought Whole Foods. Prince Harry, Duke of Sussex, married divorced American actress Meghan Markle. And the president of the United States made nice with the volatile leader of a renowned nuclear threat.
Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.
Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?
Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.
The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.
In the first installment of this series, we explored payers’ increasing willingness to provide guidance on clinical trial design and pharma’s increasing desire to seek it. With billions of dollars potentially at stake for each party, there is growing awareness that pharma and payers cannot afford missteps in the drug development process. The traditional arm’s-length (or even adversarial) relationship between drug developers and payers is not ideal for both financial success and patient welfare.
As the CRO industry continues to consolidate at breakneck speed, how pharma and biotech seek external development expertise and labor support for their potential compounds has evolved. Strategic preferred provider partnerships have often turned out to be neither strategic nor preferred, leading many companies to rethink their entire research strategy and revisit insourcing (traditional staffing) and the functional service provider (FSP) models.
There are some easy ways to improve communication on your clinical trial. But before we get into that, let’s consider how poor communication can derail your clinical trial.
The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.
The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the second of two articles that shares interview findings and insights published in the new Deloitte report, Digital R&D: Transforming the future of clinical development.
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