By Robin Brodrick

The (Clinical) Trials & Tribulations of Drug Development

Veristat had the good fortune of hosting Ken Getz as a guest speaker at its 2nd Annual International Company Meeting last month. Getz is the Director of Sponsored Research Programs and Associate Professor at CSDD, Tufts University Medical School.

Getz's talk provided an overview of the clinical trials arena and walked through how the industry has changed over the last 25 years. One of his most compelling points was that, while we have spent an immense amount of time and money trying to increase development efficiencies, the clinical trials industry is no faster today than it was two decades ago.

Primary Strategies Driving Development Productivity and Performance

Operating Changes

1990 to 1999 was the era of Project Management. The millennium brought with it: globalization, downsizing, and consolidation, which have only continued to drive productivity and performance since 2010. The addition of variable and virtual staffing is another strategy that is enhancing these initiatives.

Alliances

Mergers and acquisitions (M&A) have been prominent in the clinical trials arena for a quarter century. Other alliances in the 90's included public/private partnerships and transactional outsourcing. In the 2000's the landscape shifted to in-licensing, joint ventures, and functional service provider (FSP) outsourcing. More recently, the picture has reverted back to public/private partnerships, and has also grown to include open research and development (R&D) alliances, precompetitive consortia, and integrated outsourcing.

Technology

Technology has played a large part in the industry's efforts to expedite productivity and performance. The 90's used rapid screening, combinatorial chemistry, electronic data capture (EDC), and interactive voice response systems (IVRS). The next decade led to emerging scientific research and exploration of many '-omics' (genomics, proteomics, etc.). This was also the time period in which the concept of a clinical trial was able to be systematized, which led to eClinical Trial Solutions such as clinical trial management systems (CTMS). The twenty-tens has ushered in an era of platform technologies, companion diagnostics, integrated real-world data, and social media and mobile health (mHealth).

How Can We Drive Development and Performance Then?

First, we must understand why the industry's efforts have not succeeded. According to Getz, there are four main reasons that performance optimization has eluded the industry: protocol design complexity, collaboration and technology solutions inefficiencies, regulatory burden, and poor public and patient engagement.

Two possible strategies for mitigating some of these issues are reviewed below.

1. The Art of Collaboration

Pharma and biotech companies are realizing that they cannot be successful alone, and that having confidence in the expertise of CROs and FSPs can help achieve aggressive goals. This can be seen in Getz's slides below, which illustrate the industry's growing reliance on outsourcing. 

Despite the willingness to partner with CROs and FSPs, some sponsor companies are not known for creating an environment that allows them to leverage the expertise they are paying for. Take a look at the infographic below to see where the disconnect is between sponsor companies and their external partners. Keeping these statistics in mind will help key decision makers develop strategies that can break the mold that the industry has been stuck in for the last 20 years.

2. Undergo a Paradigm Shift

Another key to optimizing performance is for the clinical trials industry to undergo a paradigm shift from being product-centric to being patient-centric.

Final thoughts

Getz has given clinical trial professionals a lot to think about, including the CRO/sponsor relationship. Things have become so complex and regulated much faster than the industry has been able to change and adapt. This means that the clinical trials industry will always be in a reactive state unless we dare to change. A great way to overcome these challenges and improve drug development timelines is for sponsors to engage CROs earlier in the clinical planning process so that CROs can help with protocol design and feasibility, selection of the right technology (i.e. more is not always better), and development of a patient engagement strategy.