CWWeekly’s occasional profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Staff Writer Ronald Rosenberg sat down with Ibraheem Mahmood, president and CEO of DrugDev.
Q: You’ve stated pharma companies use fragmented and ultra low-tech approaches because trials are expensive, and your company’s mission is to change that. Please explain.
A: They [pharma companies] are just moving out of the paper and fax age. We need to build clinical trial operating systems—simple and single technology-enabled services—to run clinical trials. We need to aspire to a world in which clinical trial doctors can use one piece of software to guide them through what they are supposed to do and when, from legally signing up for the trial through patients visits.
Everything should work through the same portal that runs their clinical trial and seamlessly connect the investigators to everyone they need to work with across the pharmaceutical industry.
Nobody has this system today, despite the fact that everyone in the industry seems to want it. Technology vendors need to partner with customers and the academic research community to come up with pragmatic approaches to achieve this goal. That’s why DrugDev began: to help the clinical trials industry run faster and smarter and to achieve more cost effective trials.
Q One of your goals is for sponsors and CROs to change their long established clinical trial processes. What are your initial ideas and how will you gain industry acceptance?
A: Our mission is to help the world conduct more trials by enabling more cross-company collaboration; standardization while offering a beautiful technology experience. People involved in running clinical trials at all levels are very receptive to using new technology-powered processes and that’s because of just how pervasive, powerful and easy it is to use online technology.
I heard a company in Cambridge, Mass., replaced all of its employee workstations with 1950s technology like typewriters as an April Fools’ Day joke. It really helped people see just how productive information technology has made us.
The problem is not that people reject new processes. It’s that they don’t want to use technology that sometimes makes them work harder and they don’t want to take big technology risks when patient safety and regulatory oversight are involved.
We’re gaining acceptance because we’re a new generation of eClinical technology and we have the scale and industry credibility to be trusted partners to customers.
Q: How will you move virtual trials forward this year? What are some of the challenges from sponsors and regulators in the U.S. and Europe that could delay their acceptance?
A: DrugDev is beta testing a new platform to help sponsors and sites communicate more easily with study participants. It’s a platform that can wrap an ecosystem of point solutions with specific capabilities for virtual trials into a consistent, transparent and pleasant patient experience. It’s been developed by our Innovation Lab and currently is being tested by a number of sites around the world.
There’s a lot of talk about virtual trials, but there still is widespread concern about how regulators will respond to potential questions about privacy, security and access. We believe the likely compromise will be trials that are more “patient-centric,” and that the roadmap to this goal involves interoperable tools that create a single user experience for sponsors, CROs, sites and patients to interact with one another.
It’s why DrugDev sought to create a better experience for all stakeholders involved—sponsors, researchers, monitors and patients.
Q: What can be done to thoroughly change the payment system, including 90-day payment cycles, and gain wider acceptance of true start-up costs plus unanticipated ancillary expenses sites often incur?
A: Regarding the payment system, it’s very understandable why one of the biggest frustrations sites have is the investigator payment process, yet it’s one of the most fixable. There is no reason sites should have to wait 90+ days to receive payments if they have performed their obligations. However, we continue to hear this is a common occurrence.
Our payment process routinely pays sites within 30 days—usually less—after EDC activity has been provided to us. By automating the payment process, providing sites with the appropriate support tools and implementing standard contracting terms, the economic burden on sites can be eliminated to make it much more economically viable for additional sites to perform trials.
Getting our industry to pay sites for their true start-up costs is a bigger challenge. The current investigator grant development process doesn’t easily allow for these costs. Sponsors are under intense scrutiny to pay physicians fair market value for services performed in support of clinical trials. Unfortunately, there is no set definition of fair market value, so sponsors tend to use cost benchmarking databases, which are largely comprised of expenses that have been negotiated for prior clinical trials. If the start-up costs are unique, or haven’t been captured from previous negotiations, the investigator grant budget developed for a new trial will not contain these costs.
When sites then request payment for the additional start-up costs, they typically are denied because, from the sponsor’s perspective, the budget was developed using costs that represent fair market value. To approve additional costs could push the grant out of that zone. So it is quite a conundrum: if the costs are never approved by sponsors, they will never be captured in the benchmarking databases and, therefore, are not included in the initial budget. It ends up being a vicious cycle that frustrates the sites and leaves them economically exposed.
Our approach to investigator budget development is to infuse our real-world negotiation experience with the costs contained in these cost benchmarking databases to provide a realistic budget that is truly representative of the work that will be performed by the site.
Solving this budget issue on a broader scale requires collaboration among sites, sponsors and CROs to develop new benchmarking parameters that include these start-up costs in the fair market value calculation. There’s a big push toward standardization in our industry across many fronts, so now is the ideal time to have this discussion and put changes like this into place.
Q: For the TransCelerate BioPharma contract you won to develop and host the Investigator Registry, your cloud-based resource uses a unique identifier system called the “DrugDev Golden number.” Please explain how it allows pharma companies to create a single source for all data collected and provide new opportunities for investigators to make the trial process more efficient for sponsors and CROs.
A: Our goal is a clinical trial universe in which a study sponsor can select an investigator or site anywhere in the world and instantly get direct access to a unified master record with reliable insights they’ve never had before.
With the Investigator Registry and DrugDev Golden Number, for the first time there’s a comprehensive picture of a vast pool of investigators with the background and experience needed to work on the sponsor’s particular clinical trial.
The Registry is a shared repository of investigators that offers TransCelerate’s member sponsors the opportunity to achieve operational efficiencies both in support of and in addition to the shared investigator platform (SIP). First, the Registry matches persons and facilities to a unique identifier we call the DrugDev Golden Number; it “masters these numbers” and any associated profiles. This activity is called M&M: matching and mastering. It enables sponsors to eliminate redundant information and clean their own investigator and facility records.
Today, multiple records exist for each individual investigator both within pharmaceutical company information systems and across companies. The impact to the physician is an administrative burden of starting a new study, sharing the same documents and participating in the same training over and over again.
The aim of the Investigator Registry is to decrease this burden for investigators while, at the same time, driving efficiencies for study sponsors by assigning a Golden Number to each investigator across all systems, so companies can track internal activity and avoid repetitive tasks. The Golden Number also enables the mastering and sharing of investigator and facility data across companies—with appropriate consent, of course.
The Registry assigns the Golden Number to all user and facility profile records, with a master copy of the profile information stored in the Registry so it can be accessed by the SIP as well as other pharmaceutical company systems.
This technology has the potential to enable sponsors to truly understand the investigators and sites running their trials. The Registry and Golden Number bring us much closer to making this a reality.
Email comments to Ronald at firstname.lastname@example.org. Follow @RonRCW
This article was reprinted from Volume 19, Issue 16, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »