OR WAIT null SECS
Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Kathy is using the power of technology to introduce new experiences and expectations to make the clinical research ecosystem better for patients, healthcare providers, sponsors and regulators. With over thirty years of experience in clinical research working in different geographies and across various TA, Kathy has worked with various organizations to advance their clinical operations and business processes to a better operating model.
To really understand the issues and barriers preventing more efficient and effective clinical research, I went to the field to gather perspective from the core contributors.
When I joined Oracle Health Sciences last year in my role as Global Head of Clinical Innovation, I was fully aware of my first task at hand: to acquire a deeper understanding of the issues and barriers that prevent clinical research from being more efficient and effective in order to help deliver the most value to our customers and the industry.
To accomplish this, I turned to the field in which I myself had been a member of for over 30 years, gathering perspectives from the core contributors to clinical research: study team members, site staff, and patients, which I share along with my insights in the report “Navigating the Changing Clinical Trial Landscape, A Perspective from the Field”.
To address cross-functional issues in study design, conduct, and reporting, I approached the study team which revealed a strong desire to “keep the status quo” and appeared to be closely tied to self-preservation. This position was often justified with the claim that regulations were a barrier. However, there was strong support among study team members for improving capabilities within a given work stream, as long as they did not result in a significant change to the function itself.
When asked about the top challenges investigator sites face today, a majority of them were related to lack of support from the sponsor or CRO in conducting clinical research, with the main sources of pain tied to delays in the budget and contract process, lack of support for those new to clinical research, and insufficient data collection methods.
Study team members and investigative site staff working directly with patients in clinical trials helped represent the patient perspective. The overwhelming issue related to patient recruitment was the lack of awareness among patients about clinical trials. Not only are they often unfamiliar with what clinical research is, they also don’t realize there are clinical trials they could benefit from. Other issues touched upon the treatment of the patient; the lack of support for them; and their lack of ability to provide feedback. Most importantly, patients want to be treated as humans-not “subjects”-they want to be appreciated and acknowledged during and after the trial.
Finally, to assess the entire clinical trial landscape, I spoke with biopharma leaders to get their perspective on trends in the industry. According to these stakeholders, there is a strong commitment to leverage automation technology that currently exists in the piloting phase to embrace new ways of working that add value, and to promote the use of central IRBs.
As with every journey, navigating the path requires the consideration of potential obstacles. It starts with verifying those issues that are worth fixing and prioritizing the work needed to address them. Some problems are less obvious but their pain is felt often. I wanted to learn what problems really need our attention. I often use the example of a home. The exterior of a home may have an overgrown lawn that needs to be cut, and this problem is easily identified in the community. At the same time, the interior of the home has a hole in the ceiling and water is continually leaking and causing damage and disruption for the residents. The impact and importance of fixing these two problems is different; one problem is more obvious but less important (the lawn), while the other is less obvious but much more disruptive and painful (the leak). This field research and subsequent report reveal the four “leaks” in clinical research that will be critical to fix. The goal in sharing these insights is to unify the industry and help each other evolve, so that we can work together to remove the barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patient waiting in need.
Kathy Vandebelt, Brand Insights Contributor, Global Head of Clinical Innovation, Oracle Health Sciences