The 1980s saw an escalation in the number of CROs serving global biopharmaceutical companies. Although CROs began as small, specialized firms with specific offerings, by the late 1990s, study monitors or in-house clinical research associates (CRAs) performed all study startup activities, including all communication and document collection.

This exponential growth necessitated constant vigilance in CROs answering the questions: Are we continually scrutinizing our clinical trial process to best serve our customers? Are we improving on the processes that sponsors used before we came along?
Outsourced companies needed to operate in ways that were equally or more efficient than their sponsoring counterparts. They also needed to keep costs low in order to manage the increasing scale of clinical trial conduct.

As the traditional model was not sustainable, CROs developed a global SSU organization where fewer individuals were required to start a clinical study. Global oversight spanned multiple time zones and geographies. The problem with this model is that it created other challenges requiring more efficient and predictable solutions; there was a risk of continually reinventing the wheel.

Technology in clinical study conduct
In its initial uses, technology always focused on the clinical study conduct phase, i.e., after subjects were enrolled in the study. Systems that came out of this included Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and Electronic Data Capture (EDC) systems such as e-CRF and e-PRO, study budgets, and monitoring operations. These were all specialized systems that didn’t look at the end-to-end study startup process or seek to eliminate redundant tasks between sponsors and CROs. Unfortunately, study startup functions never received significant attention from the tech world.

A changing landscape
As global and local CROs sought to work with the same clinical study sites, the competition grew. As a result, study sites became more adept at itemizing the costs of clinical trials. To this day, sites continue to request a trial sponsor’s fixed costs related to running a study, such as Internet fees, site coordinator salaries, etc., rather than accepting an initially undetermined amount based on the actual work performed. Having to define the financial terms of the CRO-site relationship in this way makes a formerly straightforward and simple contract negotiation process complex and time-consuming.

Also, as new countries and sites continue to enter the clinical study arena, there is a growing need to quickly build skill sets and domain knowledge in study startup and regulatory practices. At the same time, with more local CROs proliferating globally, clinical study projects experience high turnover and instability. Bringing on a new resource requires a large time investment in training and hands-on experience.

The cost of bottlenecks
Yet another aspect of the difficulties both CROs and sponsors face in launching clinical trials is the cost—both financial and human—of process delays. According to a study conducted by the Tufts Center for the Study of Drug Development in 2012, it takes an average of 17 months to get from protocol approval to 100% approved sites initiated for a clinical trial. Site activation costs $1,500 per site per month, or $25,000 to get one site up and running. Since, on average, phases II to IV studies have 82 sites per study, this can mean a total study startup cost of over $2 million.

Do the math. For every week that’s eliminated from study startup, sponsors and CROs not only save valuable time that can be directed to serving patient needs; they also gain an average savings of $30,000 per week. Yet another challenge is the patent cliff. With pharmaceutical companies standing to lose billions of dollars in revenues from expiring patents for blockbuster drugs, the race to find new, top-selling drugs becomes a sprint.

Looking at a real world, immediate example of the impact that delays can have: cancer is one of the leading causes of death in the U.S. About 11 million people are diagnosed with some form of cancer globally every year. Apart from the delays that occur from concept to protocol development, it usually takes an average of three to six months to activate a site for a cancer-related clinical trial. It takes even longer in developing countries, where the incidence and prevalence of cancer is rising. Research and development are also impacted: during the two to three-year period between initial concept and study activation, scientific advances may render parts of a clinical study outdated. This is just one known factor that results in protocol amendments and lengthier site activation.

The rising competition between global and local CROs. A lengthy contract negotiation cycle. The high cost of delays to patients and the bottom line. Turnover and training roadblocks. Outdated processes. The patent cliff. The need to keep up with scientific advances in clinical research. These challenges necessitate a technology solution that addresses and solves all of them, at a minimum.

How close are we to paperless trials?
The amount of paper generated by a single, global clinical trial would give climate change supporters nightmares, on top causing delays and adding significant cost to drug development. Is this sustainable? Administrative costs alone related to paper-based document collection and storage are enough to warrant moving toward fully electronic clinical trials.

Ironically, patient data collection methods like e-PRO and EDC have existed for some time and are now common in clinical study conduct. However, when it comes to regulatory binders and essential document collection from sites, paper is still king. This is dictated by pharma and CRO policies and procedures, and it’s where delays, high costs, and inefficiencies sneak their way into the clinical study. There is a great need to introduce technology that facilitates document collection and storage. The transition from paper to paperless requires a cultural and mindset shift.

Embracing technology is an historical imperative for SSU
If study startup history tells us anything, simply adding more resources is not the answer. The deeper issues are process-based and can’t be addressed by an increase in human capital alone. Companies have to and are now leveraging technology to fill gaps in their SSU process.

For example, suppose a sponsor or CRO uses a technology-based solution to manage the standard setup process for clinical trial submissions to regulators and IRBs. In the event of turnover, the clinical study isn’t impacted because all information is housed in the technology solution. Knowledge is not lost, risk is dramatically mitigated, and the show goes on.

With the availability of real-time data, the project management team can focus on issues and bottlenecks affecting the clinical study. Time isn’t wasted assembling and discussing status updates; instead, all stakeholders view this information in real-time via their technology solution, well ahead of any scheduled status meetings.

Real-time alerts help decision makers intervene immediately or before a major setback has occurred, instead of after the fact. This is crucial, since in conventional study startup, intervention usually happens after an issue has occurred, when it’s too late to proactively avoid the problem.

All stakeholders can view dashboards and progress reports, without the need for a dedicated resource to update progress and status. This has a huge effect on the decision making process, as clinical study managers can now access automated, at-a-glance status.

The rise of big data in clinical trials
Technology has the potential to revolutionize how we collect, handle, and parse large quantities of data, and is already starting to do so. FDA guidance on Risk Based Monitoring is geared toward identifying and using meaningful data to effectively monitor a study. A centralized monitoring system is geared toward continuous improvement in clinical study conduct and oversight to ensure “human subject protection and data quality across sites”. 

A robust reporting tool that allows study team members to aggregate data, create ad-hoc reports, and customize data visualizations enables the discovery of meaningful patterns in the data. It’s critical that reports be fully automated and that they require minimum or no human intervention. This ensures accurate, real-time data sets that help management teams make fast and reliable decisions. Risk can be continuously tracked and mitigation strategies can be adapted much earlier in the decision cycle.
Companies that adopt this model can use existing data sitting in their CTMS, EDC and other electronic systems to immediately enhance the decision making process.

Data analysis can be used to predict how long clinical study startup takes based on past and current performance, and to establish benchmarks across studies, countries, and sites. Predictive analytics could establish data-driven clinical trials as the industry norm.
One thing is clear: Large pharma companies and CROs are becoming more effective in using the diminishing resources of ‘people and time’. This has led to the development of new tools that enhance decision making, versus the old way of using one’s judgment or accumulated tribal knowledge.

Gone are the days where companies conducting global clinical development programs, across multiple studies, simply threw additional resources at various stages of trial conduct. In the current economic climate, this model is certainly unsustainable.

Mobile clinical trials
With so much happening in the mobile device and computing space, reporting via desktop computer is slowly being transformed into a landscape where study team members are able to review reports and track risk on their smartphones and tablets. All of these efforts would reduce the time required for site activation. Mobile computing is sure to be further impacted by the advent of wearable technology, as all aspects of clinical trials become subject to more agile business processes, faster data collection, better reporting, and positive, tangible outcomes.

Wring out the old, ring in the new
Do updated business models follow technological advances? In a word, yes (ideally). However, this requires the retirement of outmoded models and processes that haven’t evolved along with other advances in the clinical research industry over the past few decades.

Large pharma and CROs have invested a lot of time, money, and resources in developing and adopting robust eTMF systems, CTMS, site and investigator databases, and EDC systems. So, the thought of completely revamping or destroying existing business models isn’t practical. Tons of data are stored within them. The need of the hour is to transform the idea of  ‘data strorage for future use’ to ‘data for current use’. This means that rather than holding data as batch records, it’s transformed into real-time information.
These legacy systems can integrate seamlessly with most current tech solutions that provide the real-time capabilities. There are known advantages of hosting this type of information within a cloud-based solution; such a solution is currently the only one that answers questions to current business challenges of information availability, automated processes, and data integrity.

Clinical research, at its core, becomes not just the practice of medicine, but a collection of data about the practice of medicine. And with that data come insights, oversight, process improvement, and an overhauled industry.

A better way for the 21st century
Think of the impact social media and smartphones have had on our daily lives, and the way we view and process information: we’re used to taps, clicks, and quick swipes. The days may soon be gone when someone assembles, reviews, prints, and delivers information to managers to discuss before decisions can be made. The push toward technology is a necessary quantum leap that provides companies with a competitive advantage, supports ever-evolving business processes, and firmly closes gaps caused by lingering inefficiencies. 

References

1. “Oversight of Clinical Investigations – a Risk-Based Approach to Monitoring,” U.S. Department of Health and Human Services.

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Roshan Padbidri is the Director of Customer Success at goBalto Singapore. With over 10 years of experience in the clinical research industry, he’s planned and developed global clinical studies in Asia, the Middle East, South Africa, Australia, and New Zealand.

Maria Breaux is a technical and copywriter at goBalto San Francisco. She has over 20 years of experience in documentation across a diverse range of industries. Over 10 of those years have been in the life sciences.