- 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
- Insufficient attention is given to designing a clinical trial that will produce the exact answers needed.
Clinical trials are highly complex, and the protocol of a study itself is encapsulated in a necessarily complex and rigorous document. Accurately determining the design, structure, sites, scope, procedures, tests, subject makeup and scores of other elements that comprise the protocol is essential.
Far too often, however, the protocol selected is not correct or is insufficient for what is being studied. Moreover, the study’s all-important primary endpoint – the outcome by which the effectiveness of a treatment is evaluated – is not selected correctly. This can lead to entirely missing a drug’s effectiveness or finding a wrong or false effect of a drug that is not working.
Sponsors frequently fail to design the right protocol or select the right outcome to be studied because of time and budgetary constraints.
- Studies routinely take longer to complete than expected and needed.
Time is a precious commodity in the quest to bring an effective drug to market. Of necessity, trials have to occur over extended periods of time to gauge effectiveness and safety. That’s always factored in on the front end, but at any number of delays can and do often occur that can jeopardize important timetables.
Service providers are all over the map when it comes to timeliness in carrying out clinical trials. Regulatory approvals, site activation and subject recruitment are some of the areas where performance can be challenging, but essential, to assess.
Patient selection is an area where many trials bog down. The process of selecting and recruiting patients often goes slower than expected, and patient retention can be a formidable obstacle to trial timeliness as well.
If you need a study to be done in two years or less, and are banking on that to get your drug to market as quickly as possible, delays can be costly and possibly even fatal to its commercial viability. Study partners that fail to deliver on promises to recruit and acquire the right number and type of patients for your study can doom a clinical trial and a drug introduction.
Timeliness also is a function of appropriate study design. Trials for drugs designed to treat chronic diseases that don’t kill quickly and don’t have a binary endpoint have to be more compressed. Realistically, studies can’t take 25 years to complete. So they must use surrogate endpoints that are related positively and strongly to the real outcome. This can allow researchers to confidently evaluate effectiveness on a more realistic timetable.
- Sponsors lose touch with their service providers and, in turn, what’s happening with their studies.
Tending to hire high-profile CROs to shepherd their studies, sponsors expose themselves to the risks associated with being too hands-off, and putting far too much blind trust in their service provider network. Outsourcing such a complex and essential task to third parties can pay dividends in theory. But in reality it often puts them “out of the loop” on important decisions. That can have an impact on study timeliness, viability and cost.
CROs are often hired on the basis of assurances that their established processes and standard operating procedures will guarantee execution. And the promises imply that, to some degree, the lines of communication will be open and that all facets of its services will be transparent.
The reality is often far different, and clients often pay a steep price. What happens, essentially, is that they often enter into a “black box,” where little information goes in and little comes out once the process begins. Yes, the CRO is doing the job, but the client has no idea in advance of receiving a report or an invoice what’s going on – who’s working on the project, what they’re doing, how many hours are being tallied and how much money is being spent.
The lack of transparency and communication leaves too much to chance. That’s risky in a process in which the ultimate stakeholder is heavily invested. The result is unchecked costs, gnawing uncertainty and a potentially-jeopardized trials process.
- The real world of the approved drug doesn’t mirror that of the trial.
Clinical trials are designed to simulate the projected reality of an approved treatment. But the clinical trial environment is ultimately an artificial one that won’t be completely replicated in the real world. The real life of an approved drug will be very different from the clinical trial condition.
That can pose some big problems for drug marketers who later discover that the drug they spent millions to test and license may not work as envisioned.
Data generated in a clinical trial flows from the experiences of patients in a highly controlled environment that can produce biases in effects. Trial participants may get more attention from physicians, for instance, and the data generated is analyzed in the context of a trial.
Once the drug reaches the market, those conditions that may have colored performance are gone. Patients will miss physician visits, not take the drug as prescribed and may abuse the drug. The result is that the real effectiveness will likely be far different from what we observe in clinical research settings.
- Sponsors reflexively tap into an increasingly calcified network of CROs and service providers.
A network of “preferred providers” has emerged over the years in the clinical trials business. Consisting of established companies that have been around for years, this consortium is often in the position of being the dominant party in a relationship that can quickly become lopsided.
These sponsors have an established network of service providers that many protect and rarely look beyond, often to the client’s detriment. Rather than branching out to sites, investigators, physicians and others who might be ideal for a particular investigation, based on their specialties, performance or even geography, entrenched CROs reflexively work with their own preferred providers.
This can be a source of problems for sponsors looking to hold down costs, be actively involved in designing a protocol, participate in hands-on management of the process and gain assurances that the study will be completed on time.
It’s becoming increasingly important, and more feasible, to get out of this preferred provider cage and look for new providers and investigators motivated by something more noble and practical than allegiance to a business model.