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Increased outsourcing and globalization continue to expand the number of CROs and specialty outsourcing specialists participating in a single clinical trial. While outsourcing has brought expertise and cost reductions, the practice has changed team composition, adding more layers of complexity in managing data and clinical trials themselves.
Sponsors recognize a need for management and governance tools supportive of collaboration to realize the strategic benefits of outsourcing.
Clinicians need ways to better predict patient responses
The estimated cost for developing a drug is approaching upwards of $5 Billion dollars with a process spanning well over a decade. Coupled with high failure rates in late phase clinical trials and increased complexities in acquiring and analyzing clinical trial data, traditional approaches based on the premise of "one size fits all" are becoming less cost effective and suboptimal.
Part 2 of 2
In my last blog, I shared risk-based monitoring (RBM) lessons learned and RBM insights from the BioClinica 5th Annual BioClinica Global User Conference held in May in Orlando, Florida. Here is a recap of other eClinical sessions I had the pleasure of attending.
Part 1 of 2
It was both a great learning experience and fun to participate in another user conference, BioClinica's fifth and my third since joining the company in 2013. We spent quality time with both long-time collaborators and first-time partners.
At BioClinica's 2015 Global User Conference, I had the pleasure of leading an expert panel discussion on the future of data management. I would like to share some highlights from my perspective. Panel participants were Daun Bahr, senior director data management Orexigen; Queennette Santiago, head of data management Ultragenyx; Clara Plascencia, associate director of clinical data management Pharmacyclics; and Ann Seibel, clinical data manager BioClinica.
We promised to answer questions that came in following a recent BioClinica webinar. Here RBM expert, Trevor McCaw, addresses a two-part inquiry on remote monitoring.
Q: In risk-based monitoring, how are sponsors approaching remote monitoring visits? In remote review are monitors looking at every data point or is the remote visit guided more by the site risk assessment?
RBM experts Courtney McBean and Mireille Zerola, a member of the TransCelerate RBM work stream, address five commonly asked questions (and clear up a few misconceptions) surrounding RBM and its underlying methodology.
Data Champions in Risk-Based Monitoring
The centuries-old saying, "knowledge is power" coined by Francis Bacon in 1597, is fitting in our risk-based monitoring (RBM) conversations today. In research − trial data is power. This is becoming even more apparent as our data is being used in new ways to inform monitoring and study management decisions to run better trials.
Clinical Trial FIT-ness: New Approaches for Measuring Fat
The presence of fatty infiltration in muscles of the lower extremities (thigh and calf) serves as a proxy for impaired muscle function and metabolic status, often seen with musculoskeletal diseases like osteoarthritis (OA), Sarcopenia, Duchenne Muscular Dystrophy, Pompe disease and Polymyositis/Dermatomyositis. Most clinical research for musculoskeletal diseases relies on non-invasive imaging methodologies for assessing changes in inter-muscular adipose tissue (inter-MAT), intra-muscular adipose tissue (intra-MAT) and muscle in the lower extremities.
Risk-Based Monitoring (RBM) Evidence Mounting
In the recent paper from industry consortium TransCelerate BioPharma, Inc., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (available here) issued in November 2014, RBM gains further support as evidence from actual clinical trials is presented corroborating earlier findings cited by the US FDA and EMA.
eClinical Greetings from Barcelona!
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).
Regulatory authorities require clinical trial progress to be monitored. The site visit report, known as the Monitor Visit Report (MVR), is where sponsors provide evidence that all regulated activities have been completed along with documentation of the outcome. These reports are open to regulatory inspection at any time during a study, as well as after, and even post product approval.
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