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I recently attended a clinical trial conference in San Francisco, which focused on the adoption of clinical IT systems in clinical trials. During this conference, there was a lot of active discussion around the challenges that clinical IT teams faced in order to implement a clinical IT system, and while most of the discussion involved areas of IT system implementation and integration, a few of us spoke about the most prominent factor that raised the most attention amongst industry experts: the need for cultural change.
Many clinical IT managers expressed concerns around how they were provided with directives from management for clinical IT system adoption, and oftentimes, the vision of IT system architecture was lost through the process because of the arguments and concerns that are raised from the clinical operations team due to different interpretations and risk averse behavior.
In my experience, for instance, I recall working with Clinical IT groups to implement new IT systems, and I have seen many discussions go sour, initiatives derailed, and deadlines extended for years because of concerns raised from the clinical operations group surrounding personalized functionality and reporting, potential GCP violations, the need to design and implement countless and unnecessary data fields (which, in the long run, requires a massive amount of data entry & resources), and suggestions to keep subject visits, CTMS, and payments in separate systems to avoid further investigations in case of an FDA audit (What’s there to hide? Shouldn’t we be compliant in the first place? Why do we have such an ‘us’ against the FDA mentality?).
Why Are We So Risk Averse?
During the conference, an industry expert spoke about an excellent example surrounding the lack of technological adoption in clinical trials. In 2007, Apple introduced the iPhone, and just 6 years later, our lives have become completely dependent on smartphones. The internet industry can profile us uniquely and offer us customized advertisements that ‘follow’ us from one website to another; we could now even ask Google a question and it will find us the answer. The technologies to bring clinical trials into the new era are readily available. So, why are the healthcare and Clinical Trials sectors lagging? It is because our culture exhibits a high level of risk averse behavior.
I wrote an article about this particular topic, and it explored the fundamental culture of risk averse behavior in clinical trials. The Duke Clinical Research Institute & Duke University Medical Center released a research study that indicated that clinical operations personnel are risk averse because of the FDA, which introduced stringent regulations in the 1960’s to protect the safety and wellbeing of human volunteers including anti-kickback laws, conflicts of interest regulations, medical license revocation, and corresponding penalties & public humiliation for violators [1, 2]. As a result, many of us have become so afraid of violating regulations to the extent in which such behavior has infiltrated areas of business operations that are completely irrelevant to subject safety and business operations that have become unnecessarily extensive to ensure subject safety, such as 100% source document verification, massive amounts of adverse event data collection fields, requiring vast amounts of resources on both site & sponsor ends .
Naturally, such behavior has led to not only inefficiencies involved with internal sponsor initiatives, but also high costs associated with clinical trial conduct. For example, I heard a speaker from a major study site provide a case study on recommendations involving FDA audits at clinical sites. The site spent a significant amount of resources (both in terms of time and materials) preparing subject documentation for the FDA audit. During the Audit, the FDA representative focused on auditing areas that involved subject safety, such as ensuring that informed consents were signed, and that the site had a copy of the consent in their trial master file. Moreover, the FDA went over adverse events, by ensuring that adverse events were reported in a timely manner in addition to general regulatory documentation such as Form FDA 1572s.
When the speaker was asked about who took care of the audit preparation costs, and whether there were any initiatives involving cost awareness, the speaker indicated that such costs were covered in the overhead (which is rarely the case due to fair-market valuation in the contract negotiation process with the sponsor), and that there were neither incentives nor awareness to save costs. This example demonstrates the extent in which risk-averse behavior is applied in clinical trials.
The FDA is Not Out to Get Us.. Unless We are Negligent
While the FDA has been stringent in implementing its regulations in the past, the new FDA makes decisions that are based on fair judgment, and sufficient evidence that demonstrates negligence & unethical practices after offering clinical trial organizations the opportunity to enhance the compliance of their business operations. For instance, a major biopharmaceutical company was penalized by the FDA because of inadequate global GMP practices which led to medical product contaminations and harmed patients even after several warnings from internal quality employees to shut down manufacturing operations, calls from concerned pharmacists and fraudulently misleading reporting to the FDA, released by the sponsor, to conceal unethical practices .
The new FDA is changing its culture and guideline structure to foster innovative behavior. To demonstrate, the FDA is now encouraging sponsors to implement risk-based monitoring techniques to focus on critical study parameters, and is recommending that there is a misconception that 100% monitoring is absolutely necessary . The FDA also encourages sponsors to demonstrate that their employees have the appropriate skill sets (described below) in order to perform risk-based monitoring activities.
Why Are We Still Risk Averse?
Naturally, most of us would respond that we implement business practices and recommendations in order to enhance the safety of clinical trial subjects. While that should still be the case, we need to acquire new skills in order to identify risk. Risk involves both quantitative and qualitative facets, which requires the understanding of statistics, finance, business operations, and combining evidence-based findings with qualitative reasoning.
Not understanding the aforementioned factors causes us to automatically associate any changes with radical risks. Comprehending the aforementioned factors allows us to gather appropriate analytical information, conduct statistical analyses, interpret these analyses, and make recommendations based on rational reasoning, which enhances productivity and save costs in clinical operations. To add, without these skills, clinical operations teams cannot perform risk-based monitoring practices.
How Long Will It Take To Change?
There is a reason why clinical operations has been so slow to adopt technological innovations, and it is apparent that the reason is cultural in nature. It is not known how long we will take to foster a culture that is able to appropriately perceive and assess risk, however, we will need to equip our employees with the necessary skill sets to nurture a fertile environment for innovation. This could mean hiring employees that not only exhibit knowledge with biopharmaceuticals & GCP, but also with business, finance, statistics, and analytics. Henceforth, the answer to this question starts with another: How ready is your organization for change?
Moe Alsumidaie can be reached at [email protected].