Is the Clinical Research Business Becoming More Challenging?

As the area of clinical research has evolved, some professionals have begun to express concern that the clinical research process has grown too complex.

8 July 2015


As the area of clinical research has evolved recently, there appears to be growing frustration with some recent changes. Even some veterans of the industry have begun to express concern that the entire process behind clinical research has grown too complex, a circumstance that isn’t being helped by impatient and overwhelmed monitors. Now as an experienced member in the field myself, I can’t say that clinical research has become any more complex than it was, say 10 years ago. Nor can I say that monitors have grown increasingly impatient, but I can tell you that CRAs (clinical research associates) are working harder and longer hours than ever before. Granted the systems being used, particularly for data entry, have changed quite a bit, as has the advent of risk-based monitoring and remote monitoring; however, to say that protocols have become more difficult as a result of this is a bit of a stretch. Again, it is important to recognize that CRAs are unfortunately overworked in the industry, so to say that they are adding on to the rigor of the market doesn’t entirely take this allegation into account.

On top of this increased workload is the burden of traveling to various research clinics located across different regions of the country in order to review and verify the source data that is being collected by the research clinics and Investigators. Essentially, CRAs are required to ensure that the data being collected on paper matches with the data being entered in the EDC (electronic data capture) systems that the contract research organization (CROs) and Pharmaceutical Sponsors ultimately analyze and submit to the FDA for review. It is becoming quite evident that this rudimentary system that may have worked well for the last several decades is in need of some drastic disruption. Thankfully, new solutions are beginning to emerge in this space.

Solving problems such as the management of workflows revolving around source data verification (with which CRAs are required to comply with as per Pharmaceutical Sponsor and FDA guidelines) is one of the primary inefficiencies that exists in the clinical research industry.  Getting CRAs’ access to source document verification in the secured cloud that is HIPAA- as well as FDA CFR Title 21 Part 11-compliant is the key to unlocking this dilemma and freeing up time for more thorough and proactive activities that are currently being ignored. The bottleneck of research Sites receiving employees’ payments for work performed has always occurred at the source data verification step, the critical activity that involves a CRA reviewing the data collected by the research clinics. In the vast majority of cases, the old-fashioned method of source data verification continues to be the industry standard. A recent shift towards remote-monitoring has eliminated the need for CRAs to travel to research clinics on a regular basis, allowing them instead to conduct their monitoring visits online on platforms such as Intralinks VIA®. This system should, at least in theory, reduce CRA workload, as well as provide research clinics with more timely payments.

In reality, the perceived increase in rigor in clinical research more so comes from the fact that supply for studies is relatively low while the demand for them (among research Sites) has increased, creating a more competitive environment. What research clinics can start to do in order to gain a competitive advantage is to secure their documents within these FDA approved electronic workspaces.

One particular marketing tool that I have already started implementing at my research clinics involves creating pre-screen databases within these virtual workspaces where we have already identified qualified, potential study participants that likely could enroll in a particular study. Before we are even awarded the study we grant access to this de-identified pre-screen log within our workspace to the CRA in charge of site selection and let them see firsthand the list of patients we could theoretically enroll in the study. We have found much success with this method and have been awarded several highly sought-after projects strictly because of having the ability to share these workspaces with the key decision makers in charge of awarding studies to research clinics.

Ultimately I don’t believe that the clinical research business has become any more challenging. It’s definitely true that the market is currently in a bit of shock as a result of the low supply and high demand already mentioned, and this has, to some degree, made things more challenging. Even so, this seems to be more of a temporary effect and not something that should be truly indicative of the rigor of the industry as a whole. Finally, all business models change over time, which is especially true when disruptive technologies emerge that can reduce some of the inefficiencies that may have existed for decades. It is in our best interest as research clinic and CRO leaders to put our organizations in the best possible positions to win. Having a virtual workspace is one way to accomplish this.

Dan Sfera

Dan Sfera

Dan Sfera is the CEO and President of The Clinical Trials Guru, LLC and DSCS Sweat Equity & Investments, LLC. Through these two companies Dan assists Sponsors and CRO's with Site Selection, Research Staff Training, Recruitment, Contract and Budget Negotiations and Business Development. Dan is also owner, partner and advisor for dozens of clinical research sites across the United States as well as Internationally. With a focus on marketing, finance and operations, he and his team have helped successfully launch many research organizations in the past 10 years.

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