Clinical supplies (CS) can be a rate-limiting factor to initiation of studies because of factors such as insufficient bulk material, inadequate forecasted demand, accumulation of delays (such as manufacturing delays), or a sudden acceleration in the timeline for the study’s start.
As the care partner of a two-time cancer survivor who has benefited from being in more than one clinical trial, I am passionate about banging a loud and insistent drum that more patients need to have the opportunity to get "tomorrow's medicine today." After all, isn't that what clinical trials are all about? My life partner participated in a Phase II clinical trial for chronic lymphocytic leukemia (CLL) 17 years ago — and has been in remission ever since. The combination therapy he received in that trial is now one of the standard treatments for CLL. We are both grateful. So, why are only a tiny percentage of all cancer patients participating in clinical trials?
To some extent, the Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2)1, released Nov. 9, 2016 (and affectionately referred to as ICH E6 (R2)) has come and gone without much fanfare.
Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment.
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.
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.
The lack of diversity of age, race, and gender in clinical trials significantly impacts healthcare in several ways. Most acknowledge the importance of a diversified patient pool in accelerating medical discovery and pre-empting safety issues that may surface post-approval. A lack of diversity can foster ongoing distrust of medical institutions. And trials designed for a homogeneous group often result in avoidable hurdles to recruitment and retention.
Understanding the proper role of social media is an important challenge for pharmaceutical companies when it comes to “connecting” with potential patients and building their levels of trust. In 2017, strategies that involve traditional mass media — such as TV and print ads — are far from dead; however, social media offers clear advantages to building recognition for a drug — and awareness of its efficacy — in ways that can be targeted to very specific audiences.
Return on investment (ROI) is a key metric for business performance, and well-functioning organizations typically bring their stakeholders high ROI. The “return on” concept can also be applied in measuring how well organizations engage with their customers.
There are so many challenges around designing clinical trials that it can often be difficult to decide where to focus your efforts and resources to improve the process. Based on our recent surveys of clinical trial participants, we see that early engagement with patients can change the course of a study for the better — and research shows it can directly impact the cost of conducting the trial as well.
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