- Launched his first international clinical trial in a cardiology clinic basement in 1989.
- Founded Evidence Clinical & Pharmaceutical Research; built it into a leading contract research organization in Eastern Europe before it was acquired by Worldwide Clinical Trials.
- Clients have included Pfizer, GlaxoSmithKline (GSK), Bristol-Myers Squibb, Boehringer Ingelheim.
- Has conducted hundreds of major clinical trials and authored more than 40 published scientific papers.
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Clinical Trials - Better Ways to Bring Life-Improving Drugs to Market
- The concept of risk-based monitoring is being embraced as a tool to maximize trials efficiency.
An alternative to the costly tactic of blanket monitoring of multiple trials sites and patients is to be more selective and discriminating about deploying resources. The approach, well-embedded among some of the more progressive CROs, is to try to determine which sites are at risk or have been shown to have more problems in compliance. Then, once identified, these sites and their participants are able to receive an appropriate level of scrutiny. Monitoring at other sites not “red-flagged” can then be scaled back.
If pursued smartly, this emerging strategy has the primary effect of reducing study costs without jeopardizing study integrity. Monitors will conceivably be able to spend more time on sites that may be at risk of not conforming to the study protocol. Given the numbers of sites and patients that can be involved, this approach, which also goes by the terms "adaptive" or "needs-based" monitoring, has the effect of improving and streamlining a tedious, time-consuming, but vital task.
- Electronic health records offer a glimpse of new approaches to trials.
The slow, but steady transition to electronic health records is opening up new opportunities to change the very nature of how drugs are evaluated for effectiveness and safety.
An emerging trend in some quarters is to try to use real-world patient data instead of solely relying on that specifically produced in a clinical trial. The notion revolves around the concept of taking data that’s collected in the electronic health records of participating clinical investigators and using it in the trial.
It’s definitely a trend to somehow try to use this powerful resource, but it’s not totally clear at this point how to make this work to the advantage of sponsors doing trials. Electronic data capture (EDC) is now a firmly entrenched practice, having almost completely replaced paper Case Report Forms. But the bigger, long-term opportunity may lie in using the power of electronic records to enable a shift in focus away from having to prove efficacy in a trial toward demonstrating the effectiveness of a treatment deemed safe and that an actual patient is taking.
- Innovative sponsors look to possibilities of exploiting deeper patient involvement.
With the rise of social media, instantaneous communication and "big data," sponsors have new tools potentially at their disposal to fundamentally change the human element of trials.
The always-challenging patient recruitment process could be changed and improved with the ability to more readily locate, assess and communicate with ideal candidates.
The steady breakdown of communication barriers also could yield more direct involvement by patients in clinical research. Instead of being passive subjects in a study, participants could conceivably share their experiences with fellow patients or others in their social networks. That would have the potentially positive effect of generating more real-world information about how the treatment under study is performing. This could be especially useful in studying treatments for slow-developing cancers and rare diseases.
- Prices and services of trials are growing more standardized, leaving sponsors at the mercy of providers.
Accompanying a steady rise in the influence and participation of global preferred provider CROs, there’s a growing tendency for prices to decouple from the costs of providing them and to become more standardized across the industry.
Instead of pricing their services individually and basing them off of the real costs that are incurred, many CROs appear to be setting prices on what the market is increasingly willing and able to bear with little pushback. This is partly the consequence of the entrenchment among leading providers of standard operating procedures in delivering clinical trials services.. In a very real sense, innovation in pricing, procedures and other elements of trials has become a casualty of a consolidating industry in which an established core of professionals routinely migrate from provider to provider. That furthers development of a set of unchallenged common practices that providers spend much time and money protecting as if they were trade secrets, when it reality they’re closer to “open” secrets.
With an increasingly captive market of sponsors eager to outsource as much of the trials function as possible and forego scrutiny, dominant CROs are inadvertently aligning how they market, price and deliver their services. The result is a creeping commoditization of the product from the service side, even as its price is less subject to market forces.
- Niche CROs are starting to show up on the radar of more sponsors.
At the same time that more clinical trials work is flowing to global CROs, some corners of the market are looking for niche providers better suited to meeting individual, unique needs – a recognition that no single entity is capable of excelling at everything.
Two kinds of niche areas are emerging. One revolves around special therapeutic or indications-specific needs. There are CROs who have carved out a niche investigating treatments for rare or orphan diseases like sickle-cell anemia for example.
Then, there are CROs which are favorably geographically-focused or based. They can support trials that for whatever reason have a location-specific component. They may work in a certain country, live there, speak the language, know the culture and are familiar with the physicians. This local CRO will likely be much more effective than a global CRO.
It’s not that a global CRO wouldn’t ultimately be capable of meeting these special needs. It’s that a specially-focused CRO – one that might, perhaps, be led by physicians specialized in a particular, specific indication – might be better at doing it and ultimately prove a much better fit.