Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.
The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.
Clinical supplies (CS) can be a rate-limiting factor to initiation of studies because of factors such as insufficient bulk material, inadequate forecasted demand, accumulation of delays (such as manufacturing delays), or a sudden acceleration in the timeline for the study’s start.
As the care partner of a two-time cancer survivor who has benefited from being in more than one clinical trial, I am passionate about banging a loud and insistent drum that more patients need to have the opportunity to get "tomorrow's medicine today." After all, isn't that what clinical trials are all about? My life partner participated in a Phase II clinical trial for chronic lymphocytic leukemia (CLL) 17 years ago — and has been in remission ever since. The combination therapy he received in that trial is now one of the standard treatments for CLL. We are both grateful. So, why are only a tiny percentage of all cancer patients participating in clinical trials?
RTSM software developed with an agile methodology and built on a modern technology stack dramatically accelerates the study start-up process and mid-stream adjustments. Customers are able to see and interact with the system before approving specifications and changes can be made quickly, without impacting study progress. The use of agile software in clinical trials enables customers to streamline internal processes and spend time on other high-value activities critical to the success of their studies.
There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single point solutions to a more integrated, non-siloed approach to study conduct. These efforts, may be rooted, at least somewhat, in work started nearly 20 years when the Institute of Medicine published To Err is Human, a call-to-action to improve safety in our healthcare system by linking it to greater quality. That seminal work was followed by various reports recognizing the urgent need to transform the clinical trials enterprise by focusing more intently on quality, which leads us to today’s sharp focus on this subject.
The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance. Stakeholders are embracing this trend through growing adoption of cloud-based technologies, such as clinical trial management systems (CTMS), source data, and the electronic trial master file (eTMF). The information they generate is flowing into data analytic tools, and with this capability, standardized metrics are gaining mainstream status.
FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.
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This article identifies the ‘low-hanging fruit’ of site optimization that, if reached for early, can replace previous time-intensive, manual methods and deliver significant cost, time and data quality benefits with minimal investment and disruption.
September and October are historically some of the best times for clinical trial recruitment.
In the summer months, we find that a lot of our clients are re-assessing clinical trial recruitment strategies. How is the study tracking to its milestones? What goals have been communicated to senior management?
It’s important to take advantage of a slow-down in activities to plan for the future. Use any downtime during summer to plan ahead for your patient enrollment push in September and into the following year.
This is the first in a series of posts to help you navigate some of the roadblocks that may impede your ability to enroll patients during the summer months.