Getting quick answers to important issues
Sponsors are fine with questions
Pharmaceutical companies routinely send out their own feasibility questionnaires, asking clinical research (CR) sites whether they have the appropriate patient population and the resources necessary for a specific clinical trial.
CR directors are accustomed to answering these types of questions, says Marietta Barton-Baxter, CCRC, administrative director of the Clinical Research Development and Operations Center (CRDOC) at the University of Kentucky in Lexington, KY.
"But what I kept finding out was that sponsors would come to us at different levels of a study's progress," Barton-Baxter says. "Some would come to us early on when a study was just getting off the ground and they'd need a lot of patients."
Other times, sponsors would knock on the door at the very end of a study when there were just a few months left in which to enroll subjects and they suddenly realized they needed more sites involved.
"And they're doing this big push and need 60 patients now, so we take on the project and then can't get the trial up and running on time," Barton-Baxter explains. "So we have a huge cost because of the start-up expenses and we never enroll a patient."
These types of experiences are what convinced Barton-Baxter that her organization needed its own feasibility questionnaire.
A feasibility questionnaire to sponsors makes it far simpler for CR sites to make informed decisions about whether a particular study is worth pursuing, says Rachel Sheppard, MBA, CCRA, CCRC, project director of the Office of Clinical Research Services and Support at the University of Louisville in Louisville, KY.
"When sponsors send out a project there is no normal practice," Sheppard says. "They might send you a CDA and synopsis, or they might send a questionnaire and synopsis."
There's no standard way they send information, and some of what they send to sites might have a lot of details that are not useful in making a decision about whether to pursue a study, she adds.
"So one of the things we've started doing is the moment we receive a project and the sponsor wants to approve our site, we send them a questionnaire for the sponsor or CRO," Sheppard says.
The questionnaire asks for information that sponsors have no problem with sending to sites, but they didn't know the sites need it, she says.
For instance, here are some questions:
- What is the overall timeline of the project?
- How many sites do you anticipate recruiting?
- How many already are initiated?
- When do you expect the last patient in?
- How many sites currently are enrolling?
- May we contact any of these sites to ask them about the protocol?
- Have there been any recruitment issues identified?
- Have there been any recruitment barriers?
- Are you providing a consent template?
- Is there a patient diary?
- If there is a patient diary, will it need to be keyed into a case report form (CRF) by the research personnel?
- Do you use paper or electronic case report forms?
- How many tabs or pages does each patient CRF have?
"These questions help us calculate the budget for a trial," Sheppard says.
For example, there was one recent project where the questionnaire's answers indicated there would be an electronic case report form with 293 tabs, she adds.
"Our budget person used this information to calculate a budget for the coordinator's time," Sheppard explains. "The sponsor saw the budget and said, 'I don't understand why you put in all this coordinator time.'"
So they gave the sponsor their budget calculations for how many hours it would take for the coordinator to handle the excessive number of tabs, and the sponsor finally understood, she adds.
"Having answers to these questions helps in a number of ways," Sheppard says. "It helps us evaluate the protocol and budget once we decide to accept a study."
And sponsors typically respond positively and within a couple of days, she adds.
At the University of Kentucky, the sponsor questions are submitted formally or informally, based on the site's experience with a particular sponsor, Barton-Baxter says.
"If the protocol is from a new company we've never worked with I'll send them a formal document to fill out, including their contact person for contracts, budgets, etc.," she says. "If it's someone I've worked with for a long time then we'll email them back and forth until we get it resolved."
Questions she might ask include the following:
- What phase is the study?
- How many patients are you planning to enroll nationwide or worldwide?
- How many patients have you enrolled?
- When do you anticipate the study closing?
- Are there any unusual considerations in this study?
"I check to see if there are any unusual circumstances that could affect starting the study," Barton-Baxter says. "We've been doing this for five or six years, and the response from sponsors usually has been very positive."
So far, no sponsor has refused to answer the questions, although occasionally they might not have answers to everything asked, she adds.
"This is in their best interest, as well," Barton-Baxter says. "If we can't complete the study or meet their timelines or requirements, it's not going to be successful for either one of us, so it's in everybody's best interest to get all the information on the table, and I haven't run into any issues."
Pharmaceutical companies routinely send out their own feasibility questionnaires, asking clinical research (CR) sites whether they have the appropriate patient population and the resources necessary for a specific clinical trial.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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