[Q&A] Streamline Your Clinical Trial Workload with Effective Project Management

April Schultz
Content Marketing Manager, Forte
April 17th, 2018

During our recent webinar, Streamline Your Clinical Trial Workload with Effective Project Management, Forte’s Director of Analytics, Wendy Tate, provided tips and strategies to help clinical researchers plan for complex clinical trials and manage their often overwhelming workloads. Here, Wendy answers more attendee questions on how to effectively manage tasks and responsibilities when conducting concurrent studies. 

 Do you use or recommend a certain program for your to-do list? 

I, personally, use Trello to organize my to-do list. I like creating cards and the ability to move them back and forth. There certainly are some downfalls to the program without paying for the full version (e.g. not being able to link parent/child tasks together), but I like the  ability to color-code labels and access it on different platforms (phone, tablet, computer). Alternatively, some of my colleagues use Asana, and I’ve also seen some people create effective to-do lists using Outlook. My recommendation is to do an online search of organizational tools to see which ones have features that you like, and then try those. If you are visual and hate lists, find something that appeals to that. Is calendar integration critical? What about the ability to “file” items under different categories? Also, be prepared to modify your processes. It took me four or five different implementations of “to-do” lists for my current workflow before I finally felt I had something that worked for me. Even so, I constantly re-evaluate to see if I can be more efficient.

What are tips to protect your time from interruptions or people needing help?

I think one of the most effective things you can do is “remote work.” Even if you can’t work from home, book a conference room on another floor, go to the local coffee shop or sit outside. This gives you a good opportunity to work on emails, get out your planner or a sketchpad and work on ideas, etc. I started doing this when I was writing standard operation procedures (SOPs) for the Human Research Protection Program (HRPP) office and it is my go-to method for getting some quality time without people walking into my office or calling my phone. I block it off on my calendar as a DNS (do not schedule) so that people do not book over it.

If it isn’t possible to do remote work (you may be tied to a desktop), you could also put in headphones and post a polite (and possibly humorous or quirky) sign. Let people know that you are trying to put your head down and get some work done. You don’t even have to have music playing in the headphones (at the least, it keeps the distractions out), but get yourself into a situation that physically shows people you are not approachable unless it is an emergency.

If you have the flexibility to modify your work schedule, come in 30-60 minutes early. A lot of people will work late, but many will not come in early. You may find that you have more of the office to yourself if you schedule yourself to come in when others are out. On that thread, take lunch an hour earlier or later than others to work while others are away at lunch (assuming that people aren’t eating lunch at their desks or not at all).

 CureCurrently, our research team works on putting out the biggest fires first. What are your suggestions for first steps to transform them to a team that prioritizes and works more effectively using the techniques you describe?

1. Time track.

Know how much time it takes to complete common tasks. This can help budget time.

2. Rate the fire.

Is it a one-alarm fire or a four-alarm fire? Remember, other people’s emergencies don’t necessarily make it your priority. Try and objectively look at important things like participant safety, regulatory compliance and staff workforce logistics, to determine how much time will it take to put the fire out.

3. Put those fires in the to-do list.

Maybe some proactive things come before the fire, maybe not. But, starting to think and act in that manner will help put items into perspective, as well as teach others (such as investigators and procrastinators) that they will have to properly plan to get the right time and attention for their items. It will also ease your stress level regarding items that need to be done “now.” As a manager/team leader, work with your staff to help them assess the “heat” of the fire and its priority. After the decision is made on where it goes on the to-do list, stand with them if others are concerned/upset/angry that the task isn’t more of a priority. Communication is key here.

Hear Wendy answer this question in the on-demand webinar recording.

 For those studies that you know will not be huge accruals (e.g. pediatric trials, rare disease trials), how do you balance the work, knowing they are important for your patients and clinical portfolio?

Feasibility! What a great topic. Yes, there will always be those studies that are so important to these populations that suffer from situations where it takes a lot of effort for not a lot of “benefit” in the traditional workforce sense. What is key with these studies is balancing the entire portfolio. Proper balance will allow your organization to invest in some of these studies. This will mean saying no to some studies to benefit the greater good. A few tips: For some of these protocols that may only enroll one person, look to see if you can implement a “just-in-time” review process. For example, many centers may not see a specific pediatric cancer patient in a given year, but want the opportunity to offer a study if they present. However, many of these patients do not have to go on study the day they come in. This could allow the center to wait to open a study until that person presents to the institution. Yes, it would be a “all hands on deck” if that person presents, as you would need to open the study within two or so weeks, but it could save the organization from dedicating resources to opening and maintaining studies that remain open for years with no enrollment.

Determine a ratio of “standard” clinical trials to rare disease studies on a staff member level. This way, it can even out the ebb and flow of rare disease studies that may see an influx of work due to a group of accruals vs. those that are a more steady stream due to a prevalent patient population.

Scrutinize studies that are not accruing but should be. Keeping studies open that are not meeting their goals (regardless of how large or small those goals are) only take up resources. If a study is supposed to be open for 12 months and accrue 10 subjects, review that study at six and nine months to see if you are on track. Decide if the right level of work has been put in to meet the accrual goal. If too much effort is being put in without enough results (which may be seen through metrics like high screen fail rate, low numbers of qualified patients coming in the clinic, etc.), then seriously consider closing the study to dedicate those resources to another study.

For rare disease in particular, make sure you see the patients in the clinic. If your organization allows review of medical records to identify potential participants, ask the investigator to identify the size of the participant pool–not an estimate, not an “I see X number of people come in every year,” but a literal list of qualified persons. This can give a solid estimate on whether the study is feasible.

If an investigator wants to open a study and resources are not available, make them part of the decision. Perhaps they have a study they can close to make room. Perhaps there are other things they can assist with (particularly in the recruitment area with doctor-to-doctor referrals or pre-screening records) to complete study enrollment and free up staff resources.

All of these methods require 1) leadership buy-in to the procedures, and 2) clear communication to and with investigators. No investigator will want to hear that their study cannot be opened, but having clear and open communication regarding why resources are limited and allowing them to be part of the decision-making process can ease the burden or provide more creative solutions to handling the workload.

 How do I use the information gleaned from today’s topic to plead the case for increased resources? How many other institutions have a single study coordinator in the role of project manager, regulatory coordinator, data entry person and budget/financial negotiator, and expect them to be effective?

I said it above and I will say it here again: time track. You do not know how much time is actually being spent on a task or by a person until you have evidence. How much is your staff working on items? Are they consistently working over 40 hours a week? Are they doing so many different things that they are less productive because of transition times between tasks/protocols? With this type of information, you can present a case for better efficiency. There are industrial/organization frameworks regarding multiple project management that describe how multi-tasking leads to an increase in productivity until a certain point, when it becomes overwhelming and decreases productivity. So, if your staff are working on a lot of projects and/or much more than one full time equivalent (1FTE), you could argue the efficiency is less than optimal by being on the downhill side of the productivity curve. Get these types of proven methodologies as background for your case. Provide empirical evidence of staff being overworked. This could be due to more than 1FTE being logged by people consistently. It could be shown through a build-up of time off because staff can’t take the time off. It could be shown through compliance rates with data entry or protocol deviations. It could be shown through staff complaints and/or turnover rates. Remember, staff turnover is expensive. It costs a lot to recruit and train a new person, but it is a lot easier to recruit and train a new person when you have a full staff than when you are working to hire a position that has been vacated and has an existing workload that needs to be covered. 

Want more answers?

Watch the free, on-demand webinar, Streamline Your Clinical Trial Workload with Effective Project Management, to hear more of Wendy’s strategies for effective clinical trial project management. Watch the recording today!

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