Ram Kamath, President & CEO
With the influx of technologies and the globalization of healthcare, one would assume that the success rate of clinical trials—across all three phases—would eventually improve. Unfortunately, a deep dive into the numbers suggests otherwise. Twenty years ago, the likelihood of approval from Phase I for all developmental candidates was less than 10 percent, and only 31 percent of Phase II clinical programs advanced to Phase III. It is 2020, and the song remains the same.
So, why exactly do only a handful of clinical trials achieve a semblance of success?
Similar problems have persisted for decades—disparate systems that do not communicate, inaccurate and unclean data, and multiple vendors are not in sync—which lead to contradictions, repeated actions, slow query response, and lack of clarity. All of these loopholes amount to a perfect storm as pharma companies—despite massive investments— struggle to overcome regulatory roadblocks. Many a time, organizations follow all FDAspecified guidelines and yet asked to undergo a retrial due to poor data management by one vendor in the trial’s lifecycle.
If there is one man who has seen the evolution—or lack thereof—that has permeated the world of clinical trials, it is Ram Kamath, founder and CEO of Vsoft Infoware. Tracing back to the 1990s, Kamath, as a consultant for a large pharma house, would switch back-and-forth between various systems, to support, develop, and enhance applications related to a clinical trial. “All the products were hosted on different servers, across locations,” he recalls.
Soon, Kamath transitioned from a consultant to a product developer, conceiving the idea for a fully-integrated solution that would cover every aspect of a trial and bring various stakeholders under the same roof. By 2008, Vsoft realized this dream by launching its full integration suite. However, Vsoft’s first client was only keen on the electronic data capture (EDC) aspect of the solution. Kamath recounts, “They did not have the resources to handle our product. During our five-year stint, they were supposed to conduct 10 studies but ended up doing only three.”
Approaching 2012, Vsoft caught the proverbial big fish, a major pharma company determined to improve its clinical trial success rate. However, again, the client did not adopt Vsoft’s fully-integrated solution but only one module of the platform. Within a year of trial and FDA audits, the pharma firm asked its sponsor to conduct a retrial. “The retrial happened because silos were provided by different vendors and the systems were incommunicado,” says Kamath, before adding that despite the failure of the trial Vsoft achieved a noteworthy milestone. “Ex-FDA auditors, hired by the large pharma, approved all the data (processed by our system). The client failed the audit because they did not follow the guideline document of the FDA. There was no fault in our system; this was a victory for us.”
Despite the setbacks, Vsoft marched forward with a positive outlook. It secured a number of certifications, introduced the CDISC standard in its data protocols, and added several new features into its alreadypowerful platform. Furthermore, Vsoft saw the need to provide related services such as training, clinical data management and analysis, statistical analysis and reporting, and drug safety services, to go along with a one-stop-shop platform. Rather than one aspect of a particular trial, Vsoft channeled its energies into the overall success rate of the trial. “Typically, in a clinical trial, a company deals with 25 different vendors, relying on 25 helplines. Our integrated solution means one helpline quickly mitigates every issue,” adds Kamath.
As a veteran in the clinical trials space, Vsoft also urges its clients (or sponsors of the trials) to streamline its vendor contracts. For example, while an EDC vendor might have a three-year agreement, an IVRS vendor might be on board for a five-year stint. In such scenarios, the “hand off ” from one vendor to another leads to significant communication gaps.
This is precisely why Vsoft acts as more than just a technology vendor, ensuring that efforts of a previous vendor are not “flushed down the drain” due to a change in personnel. “Our system—when used in its entirety—ensures clients do not have to rewrite an amendment or protocol,” he says.
Our system—when used in its entirety—ensures clients do not have to rewrite an amendment or protocol
Kamath cites an example of poor communication— between vendors—causing a clinical trial to endure a retrial. Vsoft provided the client with an IWRS (Interactive Web Response System), controlling their clinical supplies and ensuring proper treatment was given to the subject(s). However, the client relied on another vendor to generate random codes for the study. “The vendor was supposed to send the scratch codes to the clinical site, but failed in their task,” he recalls. Since the study was of the double-blind variety, the site could not disclose the details of the treatment to the subject. However, the scratch codes were needed in the case of an emergency, to indicate if a subject had overdosed on the medication. Ultimately, the FDA inspected the site and asked for the scratch codes despite the absence of related serious adverse events or death. Again, poor coordination meant the sponsor was forced to undergo a retrial. “After one year of the trial, and 18 months of submission and audit, the client was ordered to do a retrial. We could not fix the problem due to lack of integration between various systems,” rues Kamath.
The Flagship Products
These use cases point to the fact that pharma firms need to adopt an integrated clinical trial management system with dashboard like in a car that supports sound data management, statistical programming, and most of all, streamlines communication between various vendors in a trial lifecycle.
Vsoft’s fully integrated products—Clinfoware®, a web-based transactional system, aids clients to not only achieve higher clinical trial success rate but mitigate unique problems encountered during the three phases of a trial. Due to Kamath’s history of working on random code systems, labeling tools, and EDC apps, he had the wherewithal to build a “flexible system that is adaptable like treatment arms.” He elaborates, “Due to my past experiences, I could build a system that integrates the random code and labelling systems with the documentation module and EDC, giving clients the ability to understand the patient demography and accelerate the process of enrollment.” As a matter of fact, Kamath notes that modern technologies can be harnessed only through an integrated system. “You need AI and analytics to monitor data, a lot of which is entered by the patient themselves through eDiary. If all the systems are not in sync, this is impossible,” he adds.
Kamath has evidently succeeded in building a robust clinical trial management suite that can streamline adversity, reporting, history coding, and data management services—to monitor and supervise a subject in a manner that is crystalclear to every stakeholder in the process.
The future is evidently bright for Vsoft, a pioneer in the realm of replacing silo-based clinical trial systems into a fully integrated, interactive system. As Vsoft has already exhibited, this paradigm shift is essential for the pharma, biotech, and CRO industries to transition from traditional clinical trials to adaptive clinical trials—with the end goal to increase the success rate and reduce the cost of clinical trials. “We have proven that you cannot take a piecemeal approach to a clinical study. Otherwise, you deal with 50 different vendors, lose control of the trial, and have a balance sheet full of negative numbers,” emphasizes Kamath.
Driving forward, Vsoft is razor-focused on its target audience located in California, New Jersey, and parts of India, transitioning from merely allopathic medicine to herbal and alternative remedies. In recent years, patients have turned to veganism and intermittent fasting to counter diseases. However, Vsoft is incorporating a new module in its system that encourages clients to add routines to their clinical trial along with a healthier diet. As evidenced by Anderson Cancer Center, yoga has proven to improve efficacy during oncology trials.
On a closing note, Kamath has a message to Vsoft’s potential clients, “Rather than spending on multiple vendors, give us a chance to streamline your entire clinical trial. We can do one trial for free and offer a number of related services for reasonable prices.”