One crucial part of a patient-centered approach to healthcare is discovering new treatments and cures for maladies that have thwarted previous efforts. Medical research is a foundational part of the operation of many healthcare organizations, not only because of our common interest in improving health outcomes but also due to institutional benefits.
Creating access to new types of treatments can differentiate healthcare organizations in the marketplace. Today, there is a greater push for pharmaceutical and medical device companies to partner with healthcare organizations and provide clinical research as an option of care. “The idea is that by leveraging these capabilities in the healthcare sector, whether at healthcare networks, academic medical centers or cancer centers, it provides a care alternative,” said Industry Thought Leader supporting Grant Thornton, Erika Stevens.
Conducting clinical trials within healthcare organizations increases the level of risks that impact the system. While offering these trials yields benefits for healthcare organizations, meticulous and strategic planning is imperative for effective clinical trial management. Neglecting this crucial aspect can result in adverse consequences.
Common risk pitfalls
The greatest single institutional risk in clinical trials lies in adhering to the protocols, said Erika Stevens. These requirements are typically complex, and they have multiple variables.
“It’s not only a throughput factor within the clinical setting, but it’s also making sure that research patients are complying with all of the facets of the clinical trial as well,” said Louise Labrie, Grant Thornton Principal of Risk Advisory Services. This encompasses complex tasks such as obtaining informed consent as well as accurately completing and recording designated trial milestones.
Just being able to recruit and retain patients for a trial is often difficult, said Hayley Oakes, Grant Thornton Senior Manager, Risk Advisory. There can be significant logistical issues when researchers experience challenges with recruiting appropriate participants or face high dropout rates.
Not surprisingly, a robust regulatory landscape exists for this industry that requires safeguards throughout, added Stevens. Adherence to regulatory requirements is challenging and implementing risk-mitigating controls is critical.
Josh Constant, Manager, Risk Advisory, highlighted that regulators closely monitor clinical trials for the occurrence of “serious adverse events” (SAEs), which the U.S. Food & Drug Administration (FDA) defines as any undesirable experience associated with the use of a medical product in a patient. These events should be reported to the FDA if they result in death, permanent disability, a life-threatening condition, hospitalization or the need for intervention to prevent these outcomes. Clinical trial personnel are required to comply with the research protocol and accurately record data from SAEs to better pinpoint where the cause of the SAE originated and how the trial should be adjusted.
The ability to use the technology systems available within the organization to track and compile data is crucial, Constant said. Regulations also require reporting within a finite amount of time, so having data processes in place to capture information and determine whether it is trial-related is important, Stevens said. “If you do not have clean data, you do not get your product to market,” Stevens added.
Organizations also must be wary of conflicts of interest that can arise, particularly from sponsorship of the research, Constant said. Conflicts of interest can arise not only for financial reasons but from academic pressures, including professional advancement and personal reasons such as a benefit to family members. Labrie underscored the significance of organizational compliance departments in internally monitoring these conflicts. Ensuring transparency and accountability in managing conflicts of interest is essential for upholding the integrity and credibility of research outcomes.
Lastly, clinical trials can introduce financial risks, Oakes said. “Questions arise such as whether bills are being sent to the appropriate recipients and if the clinical trial budgets are being effectively managed. It’s not uncommon for trial participants to receive non-trial-related care at the same healthcare organization. This overlap can lead to issues where trial-related bills inadvertently cover non-trial care and vice versa.”
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Getting the protocols right
Constant said the complexity of clinical trial protocols alone can create a level of difficulty — after all, clinical trials are exploring new techniques or medicines that, by definition, are exploring what is at present unknown. “This inherently creates a situation that is prone to risk or negative impacts.” Constant said.
Overcoming these difficulties requires a combination of solid planning and thorough training which address the causes of errors that hinder the research. Different types of trials require different methods and protocols, so it isn’t enough to use a previous successful trial protocol.
Stevens said an important key to fruitful planning is to implement clinical trial management infrastructure. Without a fundamental system for management, organizations struggle to develop work-arounds or bypasses due to fragmented processes.
Proper planning also needs to be based on providing sufficient resources for use in the protocols. “Clinical trial operations are a big undertaking, and planners must recognize that sometimes budget constraints are going to constrain what can be allocated,” Oakes said. The lack of a clinical trial management system (CTMS) is often the culprit for breakdowns, oversights and control deficiencies.
One common source of inefficiency is when organizations conduct trial activities in departmental silos and in sequential steps. Because formalizing a clinical trial includes a number of disparate operational components such as understanding budget considerations, obtaining Institutional Review Board approval, site initiation and others, performing these in parallel processes can alleviate time inefficiencies, Stevens added.
The bottom line is even without a defined clinical trial management system, there must be a method to assess and successfully integrate clinical trial processes that can adapt to a healthcare organization’s various medical disciplines, whether it be pulmonary care, or psychiatry, or oncology, or obstetrics/gynecology, Stevens said.
Assess capabilities for better
coordination
An effective starting point for enhancing clinical trial management processes is through conducting an internal audit, which can help identify and systematically assess existing policies, procedures, personnel roles and related responsibilities. The audit will tell you whether those individual organizational procedures are effective and if they are being properly carried out. Sometimes different interpretations of the same procedure can vary and that can be a source of confusion if identified when a trial is ongoing.
Constant said assessing the capabilities of a particular site to handle a particular trial must be done to determine such factors as whether the site can handle the required number of trial participants, or whether it complies with regulatory requirements.
During the planning process, establishing a clear process flow is essential. This ensures seamless task delegation and continuity in case of individual unavailability, said Labrie. While not every team member needs to master every procedure, it’s important to have mechanisms in place to address coverage of gaps as they arise.
At times, the depth of analysis required to uncover inefficiencies exceeds the inherent capabilities of a healthcare organization alone. This is where a third-party advisor can offer assistance. Hiring a partner provides the advantage of navigating complexities such as data management, regulatory adherence, and operational capability. A third-party advisor brings a neutral perspective and ideas gleaned from various, in a non-disclosed manner. In that regard, a quality third-party partner would be one who can advise on many of the operational components of clinical trial management, whether for procurement, capacity planning, facilities management, regulatory compliance or revenue cycle management.
Conclusion
Poor clinical trial management can result in inefficiencies that not only impact studies, but also can have debilitating effects on a range of different healthcare system operations, impacting patient care, finances, reputation and even put the system in legal jeopardy. Conversely, effective clinical trial management not only advances the reputation of a healthcare system but also cultivates advancement throughout the organization, positioning it as a destination of choice for practitioners, bolstering financial stability and most importantly, creating an institution dedicated to delivering top-quality patient care.
The management of research is inherently complex and prone to complications that can derail even the best intentions. Therefore, organizations should prioritize molding their clinical trial planning procedures to maximize both flexibility and transparency. This proactive approach enables the identification and mitigation of potential complications before they affect the studies and the organization’s integrity. However, achieving this level of planning can be challenging. Leveraging the expertise of external advisors can facilitate the transfer of best practices and procedures, ultimately benefiting the healthcare organization.
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