Project Management for Clinical Trials

It is unfortunate, in my view, that more medical device companies don't apply the traditional project management skills to planning and implementing clinical trials. You'd think a half-million to ten-million dollar project would merit more preplanning.

You can only expect what you inspect
A clinical study can be doomed from the start due to poor design, or it can evaporate into a cloud of low enrollment and absence of data during implementation.

For example, recently a couple of clients have asked me to review their protocols after they had IRB approval. Here were some of the problems: the least trained people were recording critical data (patients and home-healthcare providers); subjects receiving permanent implants with no provision to follow them after the trial; screening procedures that required implanting investigational devices, but with no provision for monitoring patients who were ineligible for the trial; and investigators with big-names but who only did difficult cases, not the everyday cases required by the study. All of these design problems are fixable, but it's embarassing, time-consuming, and expensive in lost opportunity costs, to go back to the IRB for changes.

Plans are useless, but planning is essential [Eisenhower]
Everyone manages projects, whether you're planning a trip to China or changing the spark plugs. You know its a project if it has a beginning, middle, and end. You are managing the project if you take specific, planned steps on a defined schedule and within limited costs to achieve a distinct, pre-determined goal.The six steps of project management are as old as the hills and as familiar as a summer day; but it isn't always obvious how to apply the steps to clinical trials.

[1] Define the clinical project
The first step is to define the project. You need to be clear about why you are conducting the study. Is it an early developmental (feasibility) study? Is it to gain 510k or PMA or other regulatory approval? Is it to add a new indication for use? Is it a post-approval study to gain visibility, exposure, or additional clinical history? Typically the need for conducting a trial is presented to top management; top management makes the go/no-go decision. You'll learn how to craft a Clinical Development Plan and present this Plan to the project team and top management.

[2] Clinical project schedules
Next comes the Gantt chart with its list of tasks to be done. You'll make a list of every task to be done and then organize them chronologically. If you're a "lumper" you might see a clinical trial as five easy steps, if you're a "splitter" you might see it as several hundred. You want to add enough detail so the project team can understand it, but not so much detail as to confuse them.

Then you decide how long it will take to do each task. Some tasks will overlap in time, others will be staged. IRB approval is usually the slow step for NSR (non-significant risk) studies; FDA approval is usually the slow step for SR (significant risk) studies. Be forwarned: even simple trials on non-significant risk devices take an average of six months from conception to first product on first subject. You'll learn how to develop a Gantt chart to present the timeline to the project team in an easily understood format.

[3] Resource allocation, how many monitors do I need?
The most important resource you'll need to allocate is monitoring time. Calculating how many hours will be required to monitor a study, and how many monitors are needed, can be a tricky. If you manage several trials at once, integrating the workload is also challenging. You'll learn how to calculate both total monitoring time and the number of monitors needed for a study.

[4] Clinical project estimates, how much will it cost?
For each task item you'll assign a cost. The cost may be fixed (such as a one-time IRB fee), per unit of work-hour (such as internal or contracted labor), or per unit of material (such as forms or devices.) The most accurate way to do a budget is to look at the actual costs for a similar study and add 5%. You'll see why as much as 30% of the entire budget may be spent before the first device goes on the first subject. You'll also learn the traditional format for clinical trial budets: 1) costs per subject, 2) costs per study, 3) additional expenses, and 4) overhead.

[5] Site support, study management, and reporting
During the implementation process is where most studies fail. Once study start-up is completed there is a tendancy to coast while the site does the work. We'll look at strategies for site support and study management, and review some metrics for assessing if your study is on track or floundering. As a manager, these ongoing reports are your window into the progress of the study. You will receive a template in Excel for calculating the Estimate at Completion based on costs incurred to date.

[6] Study Close-out
The purpose of study close-out is to assure the site is inspection ready. Study close-out is like doing your income taxes. If you have done a good job of record-keeping all study long the close-out process will be simple. If you have been careless in ongoing record-keeping the close-out process can be expensive and complex. You will learn what records should be on file with the site and what records should be on file with the sponsor.

You will receive
[x] One computer connection (your colleagues may audit the workshop.)
[x] Forms for crafting a Clinical Development Plan.
[x] An example Gantt chart created in MS Project.
[x] A pdf copy of the example Gantt chart.
[x] A sample budget.
[x] Excel template for calculating the Estimate at Completion.
[x] A checklist of who should have copies of what study documents.
[x] An expert speaker.
[x] PowerPoint slides (in pdf).
[x] A chance for QnA.
[x] A quiz to test your knowledge.

Audience suitability
[x] Clinical research professionals who want to improve their study management skills.
[x] Clinical research managers who need better planning and reporting.
[x] CROs who want to improve their proposal skills.
[x] Executives who are planning the future of their company.

Presenter
Nancy J Stark, PhD. has worked in the field of clinical research for more than 30 years. She has designed many courses, written books and articles, and given innumerable presentations. She founded Clinical Device Group in 1990. You can read her biography by clicking here.

Date, time, registration
Availability for this five-hour event (four hour presentation, one hour quiz) is listed on the calendar of CDG's home page. It will also be available OnDemand in late June 2009. Event materials are distributed the day before the workshop or will be available for downloading. You will receive 0.5 CEU. To register click here.

System requirements
[x] Personal computer.
[x] Confirmed access to Adobe Connect.
-->(test connection by viewing this cartoon.)
[x] Telephone with speakers.
[x] DSL or T1 connection for viewing OnDemand.

Comments

[Clinical Trials]

Thanks for defining exactly what happens when you manage clinical trials. It seems like it could be very demanding. What are the biggest challenges when you're trying to manage something like this?