Are We Dismissing the "Business" Of Clinical Research?
Many of us concur that the biopharmaceutical industry is facing a crisis, and that the R&D process needs to transform entirely in order to address skyrocketing costs and minimal effectiveness.
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Many of us concur that the biopharmaceutical industry is facing a crisis, and that the R&D process needs to
The Rut the Biopharmaceutical Industry is in
The biopharmaceutical industry is experiencing significant challenges surrounding cost control and strategies in R&D. Figure 1 demonstrates that the amount of capital spent on R&D has continually increased since the 1970s, and has become increasingly volatile since 2004 [1, 2]. In 2010, the cost of receiving an NME/NBE was $2.35 billion.
Furthermore, the biopharmaceutical industry continues to experience sluggish profitability. Figure 2 illustrates a variety of financial ratios for varying SIC codes, and the biopharmaceutical sector (SIC 2834) exhibits negative median profitability compared to other industries [3]. While some biopharmaceutical enterprises are highly profitable, these negative outcomes make sense due to the high failure rate of medical innovation (particularly with small biopharmaceutical enterprises), as 5 out of every 5000 innovative compounds will reach clinical trials, and only 1 will receive FDA approval [4].
Some enterprises, such as
Despite breakthroughs in scientific innovations, there seems to be minimal talk about the
Simple and Effective Business Models for Cutting R&D Costs
According to a
from The President’s Council of Advisors on Science and Technology, high costs and sluggish productivity associated with R&D involve not only long time to market, regulatory uncertainty, and high failure probabilities, but particularly high expenses in the drug development process, with clinical trials being the most expensive [1]. Many of the aspects affecting clinical trial productivity are
A combination of suboptimal protocol design, and substantial increases in data collection are placing financial and time strains on not only sponsors, but also study sites and subjects. To demonstrate, mean endpoints/protocol increased by ~100%, and the total number of procedures increased by 57% from 2000-2010 [5]. Moreover, complex inclusion and exclusion criteria attributed towards clinical trial subject recruitment delays and retention difficulties [5, 6].
Suboptimal protocol design also increases clinical trial time and costs due to protocol amendments. The average number of protocol amendments for phase I, II, and III trials were 1.9, 2.7, and 3.5, respectively, and the costs associated with each protocol amendment was estimated at ~$454,000 (excluding internal resources, re-submissions to local authorities, and translation fees) [7]. Changes in study strategy, protocol design flaw, recruitment difficulty, and inconsistency/errors in protocols ranked in the top 10 causes that triggered protocol amendments. It is of particular interest in this context that the first amendment is in the majority of the cases implemented before the first patient was included into the trial [7].
Implementing
Another area of concern to the biopharmaceutical industry involves
While Transcelerate has issued a position paper on risk-based monitoring, much of the industry continues to exhibit a level of bewilderment on the topic, as clinical research personnel are not fully equipped with the necessary skill sets required to conduct
Nonetheless, the benefits of
The Gaps in Post-Marketing Communications and R&D
Other factors affecting protocol design and amendments include changes in post marketing strategies for clinical trial data collection, given healthcare reform and subsequent pressures affecting pricing strategies. Biopharmaceutical enterprises are now implementing post-marketing strategies to demonstrate the value of their medical products, which includes quality of life, and comparative effectiveness measures [10, 11].
Despite these efforts, biopharmaceutical enterprises are unable to implement
Unfortunately the gap currently exists with
How Soon Will We See Advancements in R&D Productivity?
While it is unlikely that we will reach the rates of R&D spend / NME approval in 1975 (Figure 1), it is probable that we would realize improvements in productivity to cut the aforementioned rate by 50%, and possibly more. Breakthrough scientific technologies during the discovery phase will likely reduce the failure rate of new medical products, and correspondingly, reduce R&D costs; this would, naturally, improve biopharmaceutical ROI in the long run. Additionally, changes in regulatory approval pathways to improve FDA communications efficiency with biopharmaceutical sponsors would also enhance NME approval rates. Nevertheless,
References:
[1]
[2]
[3]
[4]
[5] Kenneth Getz, Et Al., New Governance Mechanisms to Optimize Protocol Design, Therapeutic Innovation & Regulatory Science 10 July 2013
[6]
[7] Kenneth Getz, et al. Measuring the Incidence, Causes, and Repercussions of Protocol Amendments. Drug Information Journal, May 2011 45:265
[8] Robert M Califf. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 2006 3:496
[9] Eric Einstein et. Al. Sensible approaches for reducing clinical trial costs. Clin Trials 2008 5: 75
[10]
[11]
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