Clinical Operations Executives Weigh in on Study Start-Up Challenges
Launching a clinical trial is a complex endeavor that begins with numerous hurdles. Study start-up brings with it a range of challenges, including contracting and budgeting issues, site selection difficulties, as well as regulatory and financial barriers. Clinical operations professionals understand that it is imperative to develop plans to overcome these challenges, as all of them directly impact the progress and success of a clinical trial. It is the how to overcome that remains the discussion.
During the Marcus Evans Evolution Summit held in Boston last week, Slope's Chief Clinical Officer, Hope Meely, facilitated a roundtable discussion on the successes and failures in study start-up. The session garnered participation from more than 30 clinical operations executives representing biotech and pharma organizations of various sizes.
In this blog, we will delve into the insights shared by industry experts, highlighting some challenges they have encountered, the strategies they have employed to streamline study start-up processes, and the call for change.
Primary hurdles encountered during study start-up
1. Site selection and activation
The roundtable participants discussed the challenges of site selection and activation, citing that the process itself has even slowed from pre-pandemic years. There is a recurring lack of transparency and standardization when it comes to the process of site selection and activation across several areas of the process. Some of the specific call-outs were related to appropriate vendor selection, in-house versus outsourcing, contracting, budgeting, and individual IRB and research committee approvals. Additionally, there is recognition among the group that site staff turnover is high — and it is challenging to backfill those positions — resulting in costly study start-up delays.
2. Regulatory compliance and patient consent
The discussion also covered the importance of understanding the downstream impacts of study start-up decisions on regulatory compliance. Decisions, especially those made during the study design process, have been contributing to greater overall study complexity and patient burden, resulting in difficulty in obtaining needed approvals.
An example given was regarding study design and the associated schedule of events and its implications to patient consent. Decisions made early in the study design process, such as number and order of assessments, pull through, and patient burden, have a direct effect on patient consent language. Patient burden and consent language are important as they need to be fully approved by regulatory authorities and internal site IRBs and committees. The inability to get needed approval has affected the ability to fully capture needed clinical data, utilize collected clinical samples, or have even prevented exploratory research of biobanked samples. If compromises made on consent language are not able to be fully thought through, there is a risk of non-approval or even worse that critical collected patient data and samples will be deemed unusable.
3. Financial and resourcing pressures
The post-COVID landscape has had a profound and lasting impact on clinical trials. Participants unanimously acknowledged the prevalence of study delays and resource constraints. The aftermath of the pandemic has led to slower processes, increased costs, and the added pressure of biotechs' aggressive timelines.
The roundtable discussion shed light on the fact that the limited number of available sites and widespread site resource challenges further intensifies competition — not only for patients, but also for study participation. This situation has led to sponsors targeting the same patient and site population with similar drugs, resulting in a lack of diverse and innovative new products entering the market.
Solutions and best practices
When asked about their strategies to overcome study start-up challenges, the clinical operations executives emphasized a combination of streamlining processes and embracing creativity. One approach mentioned was bringing certain tasks in-house that would typically be outsourced to a Contract Research Organization (CRO), such as contracting and budgeting, especially when they had prior experience working with a specific site. They also mentioned eliminating site qualifications for large Academic Medical Centers (AMCs) when the study did not have unique requirements. Employing creative solutions, such as providing site hiring support for coordinators or eliminating lengthy feasibility assessments in favor of short one on one meetings with a Principal Investigator (PI), proved effective in expediting the start-up process.
Importantly, a significant realization emerged from the discussion: the primary factor impeding progress in our industry is our adherence to the status quo. The sentiment was, if we continue to do the same thing, especially in times of growing challenge, as an industry we will fall further and further behind. In order to foster innovation, we must be willing to take risks and break free from traditional practices that no longer serve us.
A call for innovation
One participant in particular acknowledged that as sponsors, they need to get out of their own way. Protocols are too burdensome for sites and for patients. Sponsors are driven to collect data to set themselves apart, when in reality this approach is exacerbating existing barriers to study start-up. Innovation is needed to make studies simpler, collect only the data that is needed, and reduce the burden on sites.
What the industry truly needs is a transformation of study execution that alleviates site timelines and resources, expedites study start-up times, and guides stakeholders through what the sites have, how to use it, and how to obtain study outcome data including samples – especially in cases of turnover. To learn more about how the Slope clinical trial execution platform alleviates these challenges by standardizing and automating study start-up activities, contact us today.
