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| Clinical Operations |
Situation A large pharmaceutical company created a Global Clinical Operations support group for study strategy and planning. The objective of the group was to assess study feasibility and to optimize study start-up and execution (CTA sent to Data Base Lock) which would reduce cycle times for starting, enrolling and completing studies while ensuring a high standard of quality.
Decision Frame The challenge was to ascertain the feasibility of a study both qualitatively and quantitatively. A study schedule plan would then be developed in collaboration with the study team based on the accumulated information and analytics.
Decision Options
- The design, methodology and support provided to the investigators could be modified to accommodate the feedback provided from patients and investigators.
- A risk analysis was conducted to allow for a best, worst and most likely case scenario, and to evaluate the possible range of study cost, milestone schedule and resource requirements for every possible eventuality.
Methodological Approach The acquired data to make the feasibility assessments and to optimize start-up and execution were sourced externally (benchmarking, IMS, epidemiology, patient and physician surveys) and internally (competitive intelligence, IVRS, project management, clinical supply invoices/inventories, finance, audit results). The information and data were qualitative and quantitative.
Study feasibility was ascertained by interviewing patients (patient profiling), and investigators (protocol feasibility & standards of care). Revisions in protocol methodology, and infrastructure support mechanisms (e.g. training, transportation, etc.) were made pursuant to the recommendations.
Investigator selection ensured a balance of the following: 1) experienced investigators previously used by a known competitor for a marketed product, 2) opinion leaders, 3) geographic locations with a defined prevalence of the target disease, and 4) investigators with whom the sponsor had experience and met performance criteria with respect to a) start up times (CTA received to 1st patient in), b) enrollment time (1st patient in to last patient in), c) enrollment rate (patients/week), d) randomization ratio (enrolled:randomized ratio), and e) queries/CRF page (Quality) to minimize time to data base lock. The sites were then tiered by performance on the variables defined in 4 (above). This selection methodology ensured a competitive edge in the market in addition to optimizing start-up, enrollment and completion times.
The Clinical Team conducted a risk analysis to evaluate any possible events that could de-rail the project with respect to: Patient, Physician, Protocol and Players (Competitors) issues - the Four P’s.
Recommended Solution
The studies addressed by these efforts set record times for start-up and enrollment. The practices set up by this department, and the support provided by the analytics, quantitative and qualitative, served as a model and a clear example of how to leverage internal and external information and data in ways to create competitive plans. Additionally, companies frequently overlook the value of their own data bases when used in conjunction with other sources and the synergistic value of departmental collaboration.
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