Along with the likes of expiring patents and the booming illicit trade in counterfeit medication, the difficulty of modern clinical trials can create a challenge for pharmaceutical companies and medical technology manufacturers looking to get their products to market as quickly as possible. The complexity of the international regulation system, as well as dwindling patient bases for clinical trials, is forcing the industry to look for new ways to economise the development process.
But a strict approval process is no guarantee against safety breaches and product recalls. At the beginning of February, a report by the Advanced Medical Technology Association (AdvaMed) stated that recall rates for medical devices were similar in the US and Europe, despite the former having a more drawn-out path to approval.
In order to overcome these obstacles, the pharmaceutical and medical device industries must make better use of the digital revolution of the last 10 years.
Better implementation of IT could hold the key to making the long process of putting a medical product into the hands of doctors and patients quicker, more cost-effective and safer. Although progress has been made by big pharma and other industry organisations, there is still more that could be done to integrate IT into the medical development world.
Adaptive trial design
One of the biggest impediments to clinical trial efficiency is its sequential nature. By and large, traditional trial methods set out to gather data on whether a drug is more effective than the current standard of care.
The data is analysed and conclusions made after the patient data has been taken and the trial is concluded, meaning that if the results are undesirable, it’s simply back to square one.
But the advance of computer technology has made another method more practical and financially viable for the industry. Adaptive trial design leverages faster methods of gathering and processing information to allow trial sponsors to alter variables within a trial as it progresses, without compromising its statistical integrity. This means that researchers can respond to safety and efficacy data from interim analyses in various ways, for example increasing the patient base or changing the focus of the trial.
This method has been adopted slowly in the past as a result of companies’ inability to react to rolling data fast enough to balance speed and reliability. But as technology improves and the e-marketplace matures, powerful new systems are opening the door to speedier and more intuitive data input and analysis.
One such example is the Almac Group’s IXRS system, the second iteration of which (IXRS 2.0) was launched in the summer of 2010.
With the capability to allow users to upload clinical data to a central system using guided menus that minimise manual entry errors, IXRS 2.0 is an example of technology that is flexible and fast enough to manage and evaluate data while the trial is ongoing, making a complex trial design like the adaptive method more attractive.
Almac’s vice president of clinical project services Valarie Higgins noted this on the new system’s launch. “Our clients are facing tremendous pressures to streamline clinical trials, improve sponsor and site productivity, and reduce timelines. IXRS 2.0 was designed to achieve all three of those goals,” she said.
Integrating EHRs and remote monitoring into clinical trials
Another issue being explored is the use of electronic health records (EHRs) as a facilitator of clinical trials. Tapping into hospitals, clinics and doctors surgeries would be a major boost for an industry that is being forced to roam ever further afield in search of decent patient bases for trials.
Like other clinical data management systems, EHRs could be an ideal way for medical institutions to contribute to medical research, speeding up the delivery of new innovations. Accessing EHRs would be advantageous on both sides of the coin; big pharma would gain access to a broader swathe of the world’s patient bases without having to set up separate infrastructure to collect data, while medical sites would be able to play a bigger role in driving innovation, not to mention opening up a potentially lucrative source of revenue through sponsor partnerships.
This trend is just beginning to emerge as EHRs start to gain traction with doctors and medical boards alike. As e-records become more sophisticated and widespread, the opportunity for pharmaceutical companies to integrate this well of information will increase in step. Healthcare IT organisations such as Health Level 7 (HL7) and the Clinical Data Interchange Standards Consortium (CDISC) will be instrumental in establishing interoperability standards to allow the smooth and cost-effective transfer of medical information from one arena to another.
This concept is being explored further with the extension of clinical data gathering into the home. Mytrus, a California-based clinical research company, has developed the technology to allow patients all over the US to register to participate in clinical trials using remote monitoring systems. Although the company is in its early days (its first remote trial studying the efficacy of therapies for Overactive Bladder kicked off in 2010) it has the backing of the US FDA and a chance to be the proof of concept for remote clinical data capture from the home.
The infinite potential of the digital space is offering a range of high-tech IT solutions to the traditional problems posed by clinical trials.
The central concept behind IT innovation in this field is to bring previously disparate systems together and make them interoperable. By integrating hospitals, homes and new technologies into the trial process, the industry could develop new drugs and medical devices for patients in a faster, safer, more cost-effective way.