It is a well-known fact that clinical trials tend to be extremely expensive and that pharmaceutical companies are always focused on finding new and innovative ways to make their clinical trials more efficient and reduce the costs associated with developing therapeutics. Years ago, the cost of developing a new drug was estimated to be around $800 million and more recently that number has increased to $1.3 billion. Although there are many that would argue that number higher or lower, the fact is that developing a new drug is expensive with a very small chance of getting it to market.
In addition to the financial challenges of bringing a therapeutic to the market, drug developers are also dealing with increased competition with other brands and generics coming to the market quicker and also with the increased complexity of clinical trials.
Pharma has been a leading adopter of IT solutions that help to run R&D processes more efficiently and reduce costs, mitigating risks while also ensuring the safety and effectiveness of the drugs they are developing.
Image Management
Images are becoming essential data sources in clinical trials because they offer objectivity, the ability to quantify items and visualization of the subject. Until recently, technology-driven solutions to manage clinical imaging trials have been behind the curve in meeting sponsor needs.
According to a report by market research firm Markets and Markets, the clinical trial Image Management industry is expected to grow from $567.2 million in 2010 to $1.3 billion in 2016 – a testament to the importance of imaging data and of this software to the life sciences industry.
The Hurdles
There are many reasons for this growth. Clinical trial sponsors are facing some significant challenges in managing the images associated with clinical trials and they are turning to new technology solutions to help them overcome these hurdles.
One of the major challenges sponsors face is the sheer volume of data associated with these images. In general, the advancements in IT have dramatically increased the amount of data available to clinical trial sponsors. Add in the size of image files and the issues are compounded with the data transfer and storage requirements. Clinical trial sponsors are suffering from information overload with multitudes of data coming from a variety of sources and in a variety of formats.
Although imaging data has become increasingly critical for sponsors, if it is not managed effectively the data can quickly become worthless and expensive to manage.
Clinical trial sponsors have made significant strides from the days of circulating hard copy image films. Traditionally, they have outsourced the imaging portion of their clinical trials to academic institutions and then more recently to imaging core labs because they didn’t have the internal imaging expertise to handle the process. Sponsors had little involvement with the actual acquisition, analysis or reporting of the imaging data, and would just receive hundreds of DVDs with the image files at the end of the trial to archive for compliance purposes.
However, with today’s drive to reduce the time to market and access more statistical data to support hypotheses, images have become an essential resource in the process and pharma companies have found the need to bring parts or all of their image management in house. The challenge is the lack of Commercial-Off-The-Shelf (COTS) tools available to help manage images.
Most of the tools being used to manage the growing volumes of clinical trial images are custom-developed in-house solutions, radiological archival systems and electronic capture systems, but these solutions still lend themselves to key challenges.
Some of the challenges of these types of image management solutions include:
- More potential for error as a result of the increased complexity of clinical trials
- Lack of control for sponsors when using external parties to manage their data
- Inflexibility, requiring sponsors to perform tasks a certain way
- High expense due to the high implementation and manpower costs
- Inefficiency due to being more manpower-driven than technology- or process-driven
- Minimal standard procedures to follow from trial to trial
- Lack of integration with other systems
- Lack of comprehensive functionality needed by sponsors
Landing on the Cloud
As technological advances have been made in recent years, we have seen the adoption of cloud computing technology really change the landscape – not just in pharma, but in most industries. Google Mail and Docs are prime examples of cloud computing technologies.
The cloud computing concept provides organizations with on-demand access to software applications via the Internet. Also known as “Software-as-a-Service” (SaaS), this approach delivers software as a service versus as a product and is based on a “pay-as-you-go” or subscription-based model.
The cloud computing market is expected to experience rapid growth in the coming years. Forrester Research is predicting that the market will increase from $41 billion in 2011 to $241 billion in 2020. There are five key factors driving the adoption of cloud computing technologies:
- Little or no capital infrastructure investments are required
- Access is immediate as there is no requirement for installing resident software in the sponsor’s IT/computer infrastructure
- Users have real-time access to data with business continuity and disaster recovery options
- Tight security controls
- Comprehensive functionality
These benefits of cloud computing can be realized by trial sponsors when using a SaaS-based model to manage their clinical trial images and will result in more efficient and effective clinical trials.
Minimizing Financial Investments
In the cloud computing model, the clinical trial image management solution is accessible via the Internet, eliminating the need to purchase software or hardware or to install upgrades or perform maintenance down the road. Everything is done on the software provider’s end and the user simply logs in to access the newly installed or updated software. Without the infrastructure requirements of typical software, the cash outlay at the start of a trial is minimal with a SaaS-based solution, and the time associated with implementing and maintaining the software is eliminated.
Begin a Trial in Weeks
In today’s clinical trials, sponsors often have multiple locations that are collecting and analyzing data and more specifically, images. With a typical image management system, the software would need to be installed at each location where it will be accessed. This can be time-consuming and also costly. With the SaaS approach, all users, no matter where they are located around the globe, can access the data via the Internet with an authorized login. All users have access to the latest version of the software without having to run any updates or upgrades on their end. And clinical trial sponsors are able to start a trial and collect data within just a few weeks, if not sooner.
Gaining Control
No two clinical trials are exactly the same. For some, outsourcing all aspects of their clinical trials makes the most sense. For others, outsourcing specific components of the trial process is a better option. With a cloud-based clinical trial image management solution, the sponsor has the choice to bring the full trial or part of the trial in house. With either option, the sponsor gains control of the data by having realtime access to it throughout the trial. This access enables the sponsor to be more involved during the development process, resulting in better trial design, execution and outcomes. Sponsors also gain the transparency needed throughout the trial process with this realtime access to clinical trial data, as well as the flexibility to outsource all, some, or none of the trial.
Ensuring Security and Compliance
Like every area of a pharma business, clinical trials must follow stringent rules and regulations. With the multiple locations and organizations involved in the clinical trial process, it is critical that the data transferred is only accessible by authorized users. A SaaS-based clinical trial image management solution offers the necessary measures to enable sponsors to easily share image data with external parties without compromising security or regulatory policies. Files are encrypted before they are transferred, only authorized users can access the images, and there are role-based controls to limit who can access the data and perform certain tasks. Sponsors can collaborate with readers and scientists anywhere in the world without having to move physical images or risk the integrity of the data.
A cloud-based clinical trial image management solution can also help ensure compliance with industry and governmental regulations more efficiently and at a lower cost to the sponsor and associated organizations. Finding a solution that ensures source data passes through regulatory scrutiny is not an option — it’s a must.
Leveraging Full Functionality
One myth about cloud computing solutions is that users must sacrifice functionality; however, it’s just the opposite. With SaaS-based clinical trial image management solutions, users are always accessing the most recent version of the software and are offered all the key functionality of an imaging core lab, and more.
To find the right solution that offers the comprehensive functionality needed to manage images for a clinical trial, it is important to determine whether the product was purpose-built for clinical trials. One must be careful not to select a product that has been reversed engineered for clinical trials, such as an RIS (radiology information system) or PACs (Picture Archiving and Communications system). These solutions are excellent for the tasks they were originally designed to handle, but were not designed with the needs of a clinical trial sponsor in mind.
A software solution that has been designed specifically for clinical trial sponsors will allow the management of DICOM (Digitial Imaging and Communications in Medicine) and Non-DICOM data and offer the workflow functionality needed to standardize processes throughout all stages of the trial. A robust solution will also offer the ability to customize workflows for each trial (i.e. the number of readers that must review an image, what items must be measured) and set standardized workflows from trial to trial for increased productivity.
The Value of Cloud Solutions
The use of imaging in clinical trials is taking a substantially bigger role in enabling rapid diagnosis with visualization and quantitative assessment, and in testing the safety and efficacy of drugs. However, with the increase in the use of imaging also comes the associated challenges of managing the large volumes of files and leveraging the valuable data found in these images for drug discovery and development.
Cloud-based clinical trial image management technology solutions are providing the tools to help trial sponsors more quickly, easily and cost-effectively make the go/no-go decisions earlier in the trial process and ensure the safety and effectiveness of their products that they are delivering to the market.
Venkatesan Thangaraj is president and chief executive officer of Radiant Sage. He can be reached at vthangaraj@radiantsage.com.