Despite numerous advances with e-clinical solutions, clinical trial processes have remained largely unchanged. While many drug developers have adopted paperless electronic data collection (EDC) and systems, further IT advances often have not been incorporated to improve how trials are conducted.
 
Clinical operations continue to face several challenges, such as data quality, lack of visibility, and oversight issues. Widely available solutions, including Centralized Data Monitoring and Quality Metrics, have the potential to fundamentally change drug development and improve outcomes.  
 
Rick Morrison, Chief Executive Officer of Comprehend, discusses current obstacles and how best to overcome them, and what we can expect from e-clinical solutions down the road. — KB
 
Contract Pharma: What are the current obstacles drug developers look to overcome with IT solutions?

 
Rick Morrison: In a recent CenterWatch survey, under 10% of studies finish on time and 80% of them regularly miss milestones – ClinOps correlate these delays with data quality uncertainty. Clinical teams are not only required to deliver high-quality results, but also deliver them on time. Yet they lack the visibility needed to report appropriately – meaning they do not know where to focus, are slow to investigate problem issues as they arise and make decisions, and cannot coordinate to take action. Additionally, there is often limited tracking that occurs throughout the process, making it difficult to defend actions during investigations. By leveraging the appropriate IT solutions that improve quality during studies, clinical teams can make smarter decisions and be proactive when problems arise.
 

 
CP: What products/services are available to address data quality issues?

 
RM: There are many tools that can alleviate the challenges facing clinical team leaders, including cloud-based technology solutions that can continuously improve speed and quality across a portfolio of clinical trials. This type of tool can:

•    Create rich custom analyses and reports to manage all key study metrics throughout the entire trial

•    Foster collaboration via real-time communication between clinical operations teams, sites and CROs

•    Automate data aggregation from multiple internal and external data sources, across clinical and operational functions

•    Generate audit trails so sponsors can report to investigators on the trial status from any point in time
 
CP: In what areas of clinical operations have you seen the greatest impact/advances using IT?
 
RM: The past 15 years have seen the mass adoption of electronic data collection systems, including EDC, CTMS, IVR, Safety, ePRO, etc. However, other than digitizing older, paper-based processes, nothing else has changed. Over the next several years, technology will actually enable changing the fundamental structure of how clinical trials are run, from centralized data monitoring, to RBM, to adaptive trials, and more. Other industries have been completely changed by technology and the same will happen for clinical trials in the next several years.
 

 
CP: What are the main challenges with CRO oversight and how can they be overcome?

 
RM: Experienced managers and even Chief Medical Officers among sponsor organizations who monitor CROs are often looking for more proactive ways to ensure the proper study progress and catch errors (if any) at the early stages. At minimum, it is essential to have the ability to tell a regulatory inspector that the CRO did what you hired them to do. At any given point of the project (and especially at the end when you tell the story of the study) sponsor representatives must be able to explain that they know where they were in the project and how they got where they were supposed to go. This can be extremely challenging if the sponsor doesn’t have full visibility or real-time views into the data during trials.
 

 
ClinOp leaders can overcome this by putting the appropriate tools in place and quantifying progress. This will help achieve a higher degree of credibility and confidence in the reports that the CRO produces so that statements like “the study is going well” or “we are on target” can be backed up by data. I recommend starting a CRO oversight plan, which consists of the following at each stage of the study:
 

 
Study start-up:
•    Country and Site Activation
•    Patient Enrollment and Retention
Study Conduct:
•    Monitoring Visit Frequency

•    Adverse Event monitoring
•    Issue Escalation Procedure

•    Compliance with Drug Accountability
•    Database Error Rates
Study Close-out:
•    Progress to DB Lock (query management)
•    Trial Master File reconciliation/Inspection readiness
Operational oversight:
•    Budget tracking

•    Resource Utilization
•    Compliance with Audit Plan
 
CP: What solutions can we anticipate to advance drug development in the near future?
 
RM: We’ve seen the digitization of paper-based clinical trials with EDCs, IVR, CTMS, Safety, ePRO, etc, but overall the processes of clinical trials have remained largely unchanged. Over the next several years, solutions that utilize these digital systems to fundamentally change the processes and methods of clinical trials will drastically advance clinical development and allow ClinOp leaders to analyze and track the overall quality of trails. These solutions will be purpose-built for life sciences, cloud-based, and will enable every person involved in the clinical trial process to do their jobs better than ever before possible.