Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.
You’ve heard the phrase “two-way street,” where a situation or relationship involves mutual give and take. Perhaps the first example that comes to mind is a friendship. But have you ever thought of clinical trial development as a two-way street?
This three-part article series will look at how best to procure, manage, and implement best practices in this complicated market.
Patients have an irrefutable role in shaping the care they need. We have come a long way since the days when the idea of involving patients in healthcare product development was controversial, if not unheard of. In recent years, the healthcare ecosystem, and the role patients play in it, has evolved in a promising direction, leading to a much deeper understanding of the impact the patient voice can and should have in healthcare.
Most of my career has been on the good manufacturing practices (GMP) side of industry, where, despite moments of ambiguity or confusion, everything is presented in black-and-white terms. And over the last five years or so, I have had the pleasure of supporting and/or overseeing the good clinical practice (GCP) side of industry, experiencing the more “human” side of the business.
In your opinion, what’s the No. 1 problem when it comes to clinical trials?
In my 2016 book about drug development, Nesiritide,1 I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.
Clinical events classification (CEC) — a scientifically rigorous, systematic, comprehensive, unbiased, blinded, and independent assessment of clinical outcomes, particularly for studies that span regions and clinical settings — is a critical step in clinical research. CEC is essential to secure U.S. Food and Drug Administration or European Medicines Agency approval for drugs and devices in many therapeutic areas, such as cardiovascular, nephrology, endocrinology, gastroenterology, infectious diseases, oncology, pediatrics, and respiratory medicine.
Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.
Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.
|
|
|
|
|
|
|
|
|