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Know protocols before signing on bottom line
Form team and tools to help with process
Every investigator and research administrator should make certain they understand what's in a protocol and what will be expected of them before they sign the contract.
"The protocol is your clear standard, roadmap," says Alane J. Drexler, RN, BS, MS, clinical research coordinator at the Florida Hospital Institute of Translational Research in Orlando, FL.
"Before an organization knows what is in the protocol, how can they determine whether the contract will be feasible or not?" Drexler says.
If researchers sign the contract before analyzing the protocol, then their options are limited.
Each research institution should have a system for reviewing protocols, Drexler advises.
This could be having two or three people look at the protocol or having a number of people in different departments take a look, depending on the size of your organization, she says.
Drexler offers these suggestions for how to check a protocol for a good fit with your research institution:
1. Know your own organization's research goals.
"The bottom line is, What is it about the research that makes you want to do research?" Drexler says.
Asking these questions allows the organization to measure whether the protocol being evaluated matches the organization's goals for doing research.
For example, if the bottom line goal is financial, then the protocol will need to be carefully evaluated for costs to see if the contract amount will cover all expenses, she says.
Another goal might be to promote translational research.
"Are you improving the care of patients? Is that something that's important to you for a study?" Drexler says.
There might be a study involving oncology drugs for breast cancer, and the drugs are an improvement over existing therapy, for example, Drexler says.
"This study might be a way of trying to improve care and outcomes for patients with breast cancer with this new cocktail," she says. "Or maybe the drug being studied has fewer side effects."
In either scenario, the study might help move patient care forward, and that would help fulfill a goal of the organization that focuses on translational research, Drexler says.
Another goal might be to conduct landmark research, the study of new and novel therapies.
For instance, a study might be made of therapeutic hypothermia in which a patient's body temperature is artificially cooled after a witnessed out-of-hospital ventricular fibrillation cardiac arrest, Drexler says.
In an example of this, there was a patient who received therapeutic hypothermia after a ventricular fibrillation cardiac arrest on Christmas Eve, and by April he was well enough to walk his daughter down the aisle at her wedding, Drexler says.
"Would you and your organization like to be a part of that kind of landmark therapy?" Drexler says.
Other examples of novel therapy include stem cell research.
Whatever goals an organization has, it's important for the people evaluating the protocol to keep these in mind and know how the goals are prioritized.
"This way when you receive a protocol you can measure it according to what your goals are, and it helps you to establish your mission, your purpose, and why you're doing research, and why you're going forward with these projects," Drexler says.
2. Check a protocol's feasibility, following thorough steps.
There are different stages to reviewing a protocol for feasibility, Drexler says.
"First, when you get a protocol, you should do a quick initial overview because the sponsor company will want to know if this is something you might consider doing," Drexler says.
If there are clear red flags in a new protocol, it shouldn't take time to quickly turn it down, she notes.
Review the protocol first for ethics because the study would have to be ethical for the organization to be involved, Drexler advises.
Also, review the protocol for its science and its possible conflicts with standard of care, she adds.
"If the protocol does conflict with standard of care, is there a way for patients to get back on the standard of care if they need to be?" she says.
Finally, look at the financial aspects of the protocol and see if the numbers will work.
"At this point, make a go/no-go decision," Drexler says. "If you have enough questions and don't want to get involved with the protocol any further, then it's a no-go, and let the sponsor know."
Alternately, if the protocol continues to hold promise, then it's time to do some more detailed exploring, Drexler says.
If the protocol is not given a thorough review when it's received, then research professionals might make the mistake of thinking the protocol sounds good, only to have to backtrack once they take a detailed look at it, Drexler says.
"You put it in place and get to the middle of it and find out it's more difficult to implement than you thought, and, maybe, the costs are high because there are little surprises in there," she says. "So doing a feasibility review up front can be a good way to predict whether the study will work for an organization."
Research feasibility team
If the protocol passes the quick initial review, then it's time to set up a research feasibility team. This process can be simple or complex, depending on the time available and the commitment from team members, she notes.
"This would be defining in your organization who would need to be a part of this," Drexler says. "Determine who would have final say and who needs to have input."
For instance, an institution's research professionals, including research managers or coordinators who do the hands-on work, should have some say over the protocol, Drexler says.
"You also need to look at the resource staff," she says. "For example, who in your lab is a go-to person if you have questions on lab pieces in a protocol?"
Also, find the same person in radiology and other units, Drexler says.
"Find people who would interact with this process and people who are committed and willing to review the protocol in a timely manner," she suggests. "Once you have that team in place, then you're ready to start looking at protocols."
3. Develop tools to break down protocol components.
The key is to develop whatever tools will help one's own organization better review protocols for feasibility, Drexler says.
It's helpful to have someone break down the protocol's components into details that will help an organization flag which items will work and which won't, Drexler says.
A look at the pull-out components should answer these questions:
Another useful tool would be a checklist for recording the various protocol pieces, and this checklist could be broken down by category, such as below, Drexler says:
"Pull all of those details out from the protocol and put on a checklist, organizing them by category, so you're not just flipping through it page by page," Drexler says. "Do this for the other reviewers, and include a column where you found that piece in the protocol, such as a page number, so they can go back and reference the written part."
In some cases, a thick protocol could be broken down into a two- or three-page Excel spreadsheet in which all of the essential details are spelled out for the feasibility reviewers, Drexler suggests.
"You could have demographic data on top," she says.
Other sections would include the investigator's initial activities, including physical exams, Drexler says.
Site evaluation of protocol
Another step is to conduct a site evaluation of the protocol, by asking these questions:
The answers to these questions might produce quick thumbs up or thumbs down on the study.
"If you know you can't get that type of patient then that might be a no-go answer to whether you'll take the protocol," Drexler says.
"Evaluate future protocols by these kinds of questions, and then once you have these questions all put together and have them broken down, send the information out to the feasibility team," Drexler suggests.
"For example, let's say several different visits involve a lab draw, then you have the lab resource person look at it to see how much blood is drawn over a period of time," Drexler says. "And you'd need a scoring system for evaluating the findings."
For instance, in answer to the question of whether the protocol is desirable, a scoring system might be one to three with one meaning "no-go," and three meaning "absolutely," Drexler says.
Another helpful took is a feasibility flow chart that identifies who has the protocol at any point in the review process, Drexler suggests.
"I would want to know that Dr. Smith in pathology is looking at it and will get it back to me tomorrow," she says. "If I was sending a protocol around a big building, I'd want to know where it's at, and if I sent it out simultaneously to many people, I'd want to know who sent it back to me."
4. If it's a 'Yes' then move to next phase.
Once an organization decides whether to go ahead or turn down the protocol, it's time to notify the sponsor and keep the communication lines open, Drexler says.
"Don't hesitate to contact your sponsor when you have issues because the sponsor can clarify questions as you go along," she says. "And once you decide you want to do the protocol, finish the budget negotiations."
Part of the budget negotiations may involve financial details, such as who will pay for the minus 80 degrees freezer that the study will require, Drexler says.
"If you accept the protocol and then realize that you need this freezer half way through the study, you'll have a problem," she says. "You don't want surprises, and you want to know if you can afford the study before it starts."
Once the financial details are worked out, it's time to start the regulatory submission process, including the IRB process, Drexler says.