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DSPMs offer a new skill set to drive data-heavy clinical trials and meet the needs of an evolving landscape.
Clinical trials are complicated and are becoming more so, driven by large global studies, increasing demands from regulatory agencies, and the introduction of new technologies. A number of advances in drug development in the pharmaceutical industry are specifically linked to the data services component, including those in the areas of data management, biostatistics, statistical programming, and medical writing.
Some of the recent industry trends that impact these businesses include electronic data capture (EDC), eDiaries, and adaptive trial design. The Clinical Data Interchange Standards Consortium (CDISC) and the electronic Common Technical Document (eCTD) are examples of trends in standardization that will benefit industry and the FDA. In turn, they also affect activities within the data services portion of clinical trials. These changes are intended to accelerate the pace at which clinical trials are conducted and data are made available for analysis and reporting.1,2
To meet these challenges and promote the proactive management of the data services aspects of a trial, the addition of a project manager with a data-oriented background is critical.
Having data- and analysis-oriented individuals direct the data services activities of a clinical trial is not new. Typically, a CRO uses a team model in which a clinical project manager is assigned to lead a full team. The clinical project manager shares responsibility with functional team members, such as the lead data manager or lead statistician. The technical leads are responsible for day-to-day management of the data functions and they report project status to the clinical project manager.
With this shared responsibility between the clinical project manager and functional team members to secure project delivery, a project challenge is introduced. Each team member brings his or her own expertise, yet neither the clinical project manager nor the functional team member is uniquely skilled to bring both project leadership and the full scope of all data services expertise to the role.
To address the challenges introduced by the sharing of responsibilities and to achieve both team efficiency and project success, i3 Statprobe, an Ann Arbor, MI-based clinical data services provider, has established a unique role: the data services project manager (DSPM). The drivers behind the concept of a DSPM are two-fold.
First, the DSPM relieves operations team members from a role in which they have one foot in project management and the other foot in the operational conduct of the project. By removing project management tasks such as timeline adjustments, budget management, meeting facilitation, and communication leadership from operational team members, they are free to apply their skills to their specialized areas of expertise.
Second, the DSPM augments the study team with a project manager who is specifically trained in data services, allowing the team to benefit from the proactive management of its tasks.
Much like the conductor of an orchestra, the DSPM directs and coordinates activities across the data services aspects of the study team—such as data management, biostatistics, statistical programming, and medical writing—to achieve desired effects: timeliness of deliverables, cost control, effective resource planning, quality of deliverables, and an exceptional level of customer service. Based on the DSPM's operational knowledge and experience, they are tuned to the detailed process steps that, if not on track, have the potential to cause delays and other project issues.
DSPMs excel in data service areas of expertise and have the desire and aptitude to conduct and coordinate activities across functions. Individuals who combine operational expertise with strong project management skills bring tremendous value to a trial—particularly when data services make up a large portion of the trial responsibilities. The DSPM role has a much broader reach and a far greater impact on project success and customer satisfaction than the administrative activities of leading meetings, typing up meeting minutes, and updating timelines.
As an experienced leader, the DSPM is someone whose depth of knowledge across all service areas has prepared him or her to ask the right questions at the right time in order to proactively direct the team and help the customer avoid costly missteps. The DSPM conducts and leads each group and harmonizes their individual efforts, culminating in successful project delivery.
New Skill Sets for DSPMs
In the case of stand-alone data services projects, the DSPM is the primary contact with the customer and uses the skills described earlier to assume full responsibility for the overall project timelines, quality of deliverables, resource and budget management, and customer relationship. In the case of a full-service project, the DSPM leads the data services portion of the study, as once again described earlier, and reports status directly to the clinical project manager.
The paradigm shift from the traditional team model to one that includes a project manager who is uniquely qualified to lead the data services portion of a trial is a key to meeting the challenges of an ever changing industry. And the role and responsibilities of the DSPM dovetail sensibly with the needs created by the increased complexity of today's clinical trials, and increased pressure on the back-end of studies to meet tight timelines with high-quality deliverables.
With the addition of a DSPM to the management of trials, a sponsor is given greater assurance that the CRO will achieve its operational obligations and exceed their expectations.
Challenge: Our client, a drug discovery and development company, requested that we freeze the database early in order to help them meet changing internal timelines. A further complication resulted when four novice lab vendors who worked on the project failed to follow operational guidelines that had been agreed to by all parties.
Solution: The DSPM's strong leadership and understanding of operational processes gave team members the freedom to focus on their tasks. Our DSPM facilitated communication with the client and between operations so that the data management (DM) lead could focus on cleaning the data. By lifting project management tasks such as timeline adjustments, budget management, meeting facilitation, and communication leadership from team members, the DSPM freed members of the project team to spend time applying their areas of expertise to technical tasks, not project management activities.
Result: A quick, clean database critical to client success. The resulting database was not only successfully frozen two weeks ahead of time, it was produced in a very clean manner, with zero queries between lock and freeze—an outcome that proved critical to meeting the client's organizational goals.
Challenge: A large pharmaceutical company requested that an interim Clinical Study Report (CSR) and analysis be treated as end-of-study deliverables rather than as a snapshot of the data. Meanwhile, a shortened timeline accelerated the end date of the project by approximately four weeks. Our engagement with the client was a global, full-service project in five countries. It involved processing 26,000 CRF pages and issuing and resolving 1700 queries, some of which were received as a bolus in preparation for the interim analysis. This study was one among four running simultaneously for this client.
Solution: Leveraging their strong relationship, the full-service project manager (FSPM) and the DSPM took a "divide and conquer" approach. The FSPM and the DSPM first divided and prioritized the work based on their time zones and core competencies. The FSPM assumed responsibility for site management, comonitoring, conducting drug safety activities, and developing detailed metrics for monitoring, CRF retrieval, and data clarification form management—all areas that would prove extremely beneficial to data services team members. Meanwhile, the DSPM assumed responsibility for leading the data services team in the rapid movement of data through the system with a level of cleanliness typical for study close.
Three FSPMs were assigned to cover the four studies running concurrently. Our response was to have one DSPM cover all four studies, which allowed that DSPM to prioritize and coordinate the workload between all studies. This arrangement positioned the DSPM to be fully aware of and respond quickly to the priorities of each of the four studies.
Result: A very satisfied client, who has returned for additional services. The CSR was delivered on time without compromising the status of any of the client's other studies. Achieving the necessary goals within the time frame provided by the client required tremendous coordination among all project participants. The arrangement engineered between the FSPM and DSPM exemplifies the concept of the second driver of the model: providing the study team with a project manager who is specifically trained in data services, which allows the team and client to benefit from the proactive management of their tasks.
Challenge: No detailed timeline was available for this medical device company's project—only the major milestones were known. For an engagement revolving around electronic data capture (EDC) and involving 500 subjects, trying to follow a road map full of holes presented difficulties for the entire data services team.
Solution: The DSPM's depth of knowledge emerged as the key to coordinating activities. Our DSPM stepped in to provide timeline management as well as leadership on budget management, meeting facilitation, and communications. The DSPM developed a timeline with detailed process steps, predecessors, and linked tasks to coordinate activities across functions. Due to his depth of knowledge across all service areas, the DSPM was able to ask the right questions at the right times to effectively direct the team and successfully keep the customer out of harm's way.
Result: The leadership not only met but exceeded client expectations. The level of leadership demonstrated by the DSPM on this project enabled both the internal team and the client a clear view of deliverable dates, all of which were met. Moreover, the clients expressed their appreciation of the expanded understanding our organization brought to the project regarding the detail behind and between each task, which it recognized as absolutely essential to the team's success.
1. J.A. Quinlan and M. Krams, "Implementing Adaptive Designs: Logistical and Operational Considerations," Drug Information Journal, 40, 437-444 (2006).
2. S.H. Collins, "EDC and the Changing Role of the Clinical Data Manager," Data Basics, 13 (4) (Winter 2007).
3. T. Pratt, "Data Management: R.I.P. or Brave New World?" Applied Clinical Trials, 15 (10) 58-64 (2006).
Amy Meszaros is senior director, strategic services, at i3 Statprobe, 300 West Morgan Road, Ann Arbor, Michigan 48108 email: firstname.lastname@example.org