Guest Column | January 11, 2016

The Achilles Heel of Clinical Study Startup - Bottlenecks

Craig Morgan

By Craig Morgan, NZCS, MBA (Hons), PMP, goBalto, Inc.

The clinical trial phase of a drug development program is by far the most costly, risky, and protracted phase of the investigative process. Over the past decade, the capitalized cost to develop an approved new drug has more than doubled to $2.6B (1), with the approval rate for drugs entering clinical development dropping to less than 12 percent. Though the most recent data released by the FDA indicate that median times to approval have decreased by a few months, the drug development process remains long and arduous. On average, a new drug requires at least ten years to move from initial discovery to market, with clinical trials alone requiring six to seven years (2). Success requires enormous resources at a time when the industry faces increased scrutiny and intense pressure to conduct faster and more cost-effective clinical trials.

The first step towards reducing cycle times and costs involved in conducting clinical research is the identification of bottlenecks. A few notable trends, which have a significant impact include:

1.Outsourcing and geographical expansion can lead to a more complex operating environment

In an effort to contain costs and to speed the clinical trial process, many pharmaceutical companies are increasingly turning to conducting clinical trials in other countries, such as China and India where costs can be as much as 60% lower, and to partnering with contract research organizations (CROs). However, this outsourcing and geographical expansion has led to a more complex operating environment exacerbating operational bottlenecks that adversely impact trial efficiency and costs.

2.Technological advances are under-utilized

Although cloud-based technological advances and opportunities for centralized coordination have the potential to shorten drug development timelines, the adoption of solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF) have not been fully integrated into the clinical trial process (3). More importantly, they do not address one of the most inefficient and costly bottlenecks of clinical trial conduct, study startup (SSU).

A Closer Look at Study Startup

Study startup encompasses the processes associated with site selection, feasibility assessment and activation, required for clinical trials. These typically involve tasks such as country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget negotiations, patient recruitment efforts, and enrolling the first patient.

Starting clinical trials is widely regarded as a cumbersome and inefficient process that is largely still paper based and prone to errors – it is also a key contributor to the cost, delays and failures associated with trials.

As a result, the SSU phase of a trial is an area requiring attention in order to reduce delays and improve efficiency. To better understand metrics within study start-up, the Tufts Center for the Study of Drug Development, in collaboration with 11 pharmaceutical and biotechnology companies, examined a comprehensive set of metrics and analyzed study data from 105 global clinical trials (4). The results indicate that the early stages of the site initiation process are areas that accounted for the majority of cycle time.  

According to Jeff Kasher, formerly VP Clinical Innovation and Implementation, Eli Lilly and Company, and now president of Patients Can’t Wait, “Patients across the globe are waiting for new therapies, but complicated study protocols, globalization, and paper-based methods of conducting trials continue to delay market entry. Current thinking looks to an improved study startup process as holding great promise for accelerating clinical trials.”

But accelerating studies is no simple task. The operational complexity of the modern global trial is on the rise, due to the use of multiple partners, complex project management environments, and geographically dispersed study sites. When these challenges are coupled with the continued use of traditional and obsolete paper based methods to manage critical workflows, cumbersome and costly processes result.

Resolving Costly SSU Bottlenecks

Obsolete processes inhibit bottleneck identification and proactive risk management

The first step towards improved SSU processes is through the identification and resolution of costly operational bottlenecks. However, the traditional methods still widely employed today lack the capability to empower clinical operational teams to proactively identify and resolve these bottlenecks and mitigate operational SSU risk. Often manually based, they lack real-time reporting capability; and as a result, risk identification occurs after the fact when their associated costs have already been incurred.

Best practices to proactively prevent SSU bottlenecks

Ideally bottlenecks and operational risks can be prevented before they materialize. So what are some of the best practices organizations should consider in preventing delays and promoting streamlined SSU processes? A recent article from the Clinical Leader highlights some key areas to focus on (5):

  1. Optimize your processes early: Make the most of cumulative learning from industry best practices and look at ways to standardize global operations.
  2. Collaborate with sites and study teams: When everyone on the team has a transparent means to assess the real-time status of documents and submissions, site responsiveness is accelerated.
  3. Establish a mechanism for secure file exchange: Make sure any solution you use includes the ability to instantly share files between sites. This will also have the added benefit of getting important documents out of email inboxes.
  4. Track activities in real-time: Doing so will allow users to quickly identify issues and resolve bottlenecks.
  5. Leverage analytics and dashboards: Spreadsheets do not have the ability to link critical data. This creates a void when it comes to visualization of data and impacts decision making. Using robust systems that can not only collect data but also provide a level of analytics will allow the team to make better decisions more efficiently.

Moving to the Cloud: The Key to Streamlined SSU

Advantages of moving to the cloud include reduced costs and greater agility. In the case of SSU, the value proposition is compelling when you consider that it enables immediate access to real-time study data and trends for trial partners around the globe.

Cloud-based SSU solutions that are fit for purpose are designed to promote best practices across complex global clinical operations, providing benefits such as process alignment, enhanced data quality and integrity, greater visibility into processes, and identification and faster resolution of bottlenecks. The value comes when various stakeholders and participants can all reference the same data in real-time versus having to refer to multiple systems or tools (or even paper) in order to obtain a comprehensive view of SSU status.

Both sponsors and CROs can benefit from purpose-built, cloud-based SSU solutions. In fact, having robust systems to support study startup is increasingly viewed as a must-have for leading clinical CROs. These sentiments are echoed by INC Research (recently named the best CRO at the 11th Annual Scrip Awards (6)). Chief Operating Officer Alistair MacDonald, describes why they chose a cloud-based SSU solution (7):

“We chose to go with a study startup solution because it offers enhanced visibility into the traditionally cumbersome process of activating sites for clinical trials. The system creates efficiencies through streamlined communication among sites, sponsors and CROs. This ultimately drives shorter timelines and cost savings for our customers.” 

In the end, realizing the goal of faster, more cost-effective clinical trials requires close collaboration amongst stakeholders across the organizations participating in clinical research. As the Tufts study indicates, site initiation processes involved in study startup account for the majority of cycle time in most trials. From study sites and investigators to sponsors and CROs, having one central cloud-based view of the study startup process is a major step forward that is sure to help study teams reduce cycle times, mitigate risks, and ultimately avoid operational bottlenecks.

 

References:

  1. US Department of Health and Human Services.  Examination of Clinical Trial Costs and Barriers for Drug Development. July 25, 2014  Retrieved November 2015 from http://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development
  2. Sullivan T.  A Tough Road: Cost To Develop One New Drug Is $2.6 Billion; Approval Rate for Drugs Entering Clinical Development is Less Than 12%.  December 02, 2012.  Retrieved November 2015 from http://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

  3. Kramer, J. M., & Schulman, K. A. (2012). Transforming the Economics of Clinical Trials. IOM Forum on Drug Discovery, Development, and Translation. Washington, D.C.: Institute of Medicine of the National Academies.

  4. Lamberti MJ, Brothers C, Manak D, Getz K. Benchmarking the study initiation process. Therapeutic Innovation & Regulatory Science. 2013;47(1):101-9.
  5. Misseta E. 2015.  Technology Trends Will Impact Clinical Trials In 2015.  Retrieved November 2015 from http://www.clinicalleader.com/doc/technology-trends-will-impact-clinical-trials-in-0001
  6. “INC Research Named Best Contract Research Organization At 11th Annual Scrip Awards.” Global News Wire, 03 December 2015.  Available at:  http://www.thestreet.com/story/13386104/1/inc-research-named-best-contract-research-organization-at-11th-annual-scrip-awards.html.
  7. Morgan C, 2015.  BI the way. Retrieved November 28, 2015 from http://www.samedanltd.com/magazine/13/issue/243/article/4220.