I am sure the readers would agree that productivity is the result of a commitment to excellence, intelligent planning, and concentrated effort. Accordingly, that is exactly what we have to focus on in order to improve the productivity in Clinical Development and Operations and shorten clinical study setup time.
Importance of Standardization
Innovative Clinical Development Organizations take advantage of standards at the earliest point in the development process, during the planning stage. Standardization of protocol elements, introduction of an end-to-end process for clinical development standards and the utilization of TransCelerate’s Common Protocol Template (CTP), coupled with the right technology, provide a platform for planning and executing trials more efficiently with a goal of getting products to market sooner.
We experience challenges in realizing the benefits of the data standards due to our limited approach to standardization.
The key is to start with the standardization from the earliest point in time – Clinical protocol. That makes sense since we know from the Gartner CDISC Standards Business Case that 80% of all benefits occur in the study startup phase.
Furthermore, we should look at extending the standardization upstream into Clinical Project Planning (CDP) and Target Product Profile (TPP).
We experience challenges in realizing the benefits of the data standards as we are typically still taking a limited approach to standardization. Some of the main challenges are:
- The bulk of standardization in clinical trials today revolves around the CDISC standards, not least because of regulatory mandates
- End-to-end standardization has focused largely on Data Collection (CDASH) to Tabulation (SDTM and ADaM)
- Standardization is at the study level with some consideration given to managing consistency across studies in a program
- Increasing complexity in study design and data sources continually challenge the current standardization approach
Importance of Process Integrations
Looking across Clinical Development and Operations processes, we still witness a very much siloed and almost isolated processes. We lack proper data and metadata-driven process integrations to elevate collaboration and information sharing which are essential for productivity and knowledge management improvements.
We are stuck in old processes and are so busy with it that we have slowed down the innovations.
Why do we experience a disconnect between for example the protocol development process and operational processes like Feasibility?
Why do we still use a ‘regulatory’ document like Clinical Study Protocol to execute our internal processes? Why can’t we streamline these processes and ensure that the right information flows through the right channels at the right time and in the right format?
The list of questions can go on and on, and the answer is simply because we are stuck in old processes and are so busy with it that we have slowed down the innovations in this area.
Lean Way Forward to Shorten Clinical Study Setup Time
In order to effectively move forward to shorten clinical study setup time, improving productivity and faster market access, we need to embrace both: Higher Standardization and Processes Integrations.
To succeed, we all need to move away from the silo-ed thinking and embrace the integrated thinking.
Looking at standards, we need to extend our standardization efforts upstream into Clinical Study Protocols, CDP and TPP and benefit from the holistic application of clinical development standards. Such a holistic view of the standards would enable us to establish proper learning feedback loops back into the organization and empower your Learning Organization. Your future products and innovations would emerge from these learning even as your resources move away or get reassigned.
Considering processes integration, we need to move away from using documents that are required by the regulations in our operational information exchange and move towards exchanging the right information through the right channels at the right time and in the right format. Such an approach would ensure that for example an EDC developer does not have to ‘interpret’ the Clinical Study Protocol in order to setup eCRF, but would receive the exact information that does not need interpretation. Or your feasibility specialist does not have to read a 100+ page document to prepare a feasibility test.
With process integrations, you can test your main study propositions, like patient population, design, treatment, activities, risks, etc. in near-time, before the protocol is finalized, thereby avoiding costly amendments.
For the lean way forward to succeed, we all need to move away from the silo-ed thinking and embrace the integrated thinking to ensure sustainable productivity gains and getting our products faster to market – our patients expect that from us.
For an extended conversation on this topic and how your organization can embrace the lean way forward, Please reach out to us for an independent and expert consultation.