CR model works for AZ investigators
PIs commit to honest enrollment appraisals
When the founders of HOPE Research Institute of Phoenix, AZ, began to envision their new clinical research (CR) organization, they relied upon both their past successes and challenges in drawing plans.
"This is the second research site I've built," says Patricia Adams, managing partner with HOPE Research Institute. "I've learned lessons from the first one."
For one thing, Adams learned that if you build a clinical trial site around a certain type of medical specialty area because there's a strong pipeline of studies in that field, then you might face a major downturn when the pipeline changes directions.
"In starting a new organization and wanting a consistent pipeline, I looked at creating a business with a multi-specialty approach," Adams says. "So if there is a lot of work available in neurology, then we put efforts in that direction, and when that dies down, we'll go to gastrointestinal studies or pain management research."
Developing a multi-specialty site was crucial to creating a CR business that would survive in the long term, she adds.
"We started with podiatry, women's health, and neurology, which are our three physician partners' specialties," Adams says. "As we grew, we added other therapeutic areas, including orthopedics, dermatology, gastrointestinal, pain management, urology, ophthalmology, and others."
Physicians who contract with HOPE Research Institute are spread out in the CT site's geographical area. They can use the HOPE Research facility to see trial participants, or they can use their own offices, Adams says.
Principal investigators also can use the institute's clinical trial coordinators at the Hope facility or have the coordinators visit their own practices, she adds. Here are some more details about how the model works:
- The PI decides how many or few support services to use: Principal investigators decide when and how to delegate the CT work. "They might delegate data entry to one of our study coordinators," Adams says. The PIs are in charge of the study, but they rely on HOPE's experienced team to assist them in areas where their expertise is thin, such as regulatory, contract negotiations, and/or budgets.
HOPE Research Institute also can provide PIs with assistance in budgeting, training coordinators, psychometrician services, contract negotiation, study accounting, personnel issues, and regulatory services, she says.
"We'll partner with the PI to put all pieces together to get a complete picture and to conduct the trial according to the protocol," Adams says. "The thing that clinicians like about that is that they can count on HOPE to provide them with qualified personnel."
- CT site expects investigators to meet their obligations: When physicians discuss building a relationship with HOPE Research Institute, Adams discusses their own responsibilities in making certain they'll meet study enrollment deadlines.
"We have straight talk about the requirements for working for HOPE," Adams says. "I've had investigators who have not been able to enroll or fulfill responsibilities seriously, so I'll then end our relationship with them."
Sometimes it's apparent early on that an investigator is not going to be a good partner, she notes.
"If you bring someone on who doesn't book time for coordinators or to attend investigator meetings, then I can see it's not going to work out," Adams says. "Those who have worked with us have consistently met their enrollment needs."
Occasionally, even the most seasoned PI will take on a study in good faith and then discover that the enrollment is not going to work as well as anticipated, Adams notes.
But for the best investigators, this is a rare experience, she adds.
Another expectation the CT site has is that investigators will become trained in clinical research.
"Just because you're a great a clinician doesn't make you a good investigator," Adams says. "For the investigator, it takes time and training to be a good clinical researcher."
- Study acquisition team reviews proposed protocols: "First, we ask investigators what they're interested in doing," Adams says. "We let investigators know that just because you're interested in this doesn't mean that there are studies of it right now."
But there might be other studies that will interest a particular investigator, so the CT site pairs investigators with the studies that are available.
"We take a look at the industry and see if we can find a match," Adams says.
"We gather feasibility information and contact the sponsor," she adds. "Then we review the protocol requirements."
For every five clinical trials the site reviews, about one is selected, Adams says.
- CT site helps PI prepare for trial: "After we obtain the sponsor's commitment, we have a pre-study visit, get the facility ready to do the trial, and make sure the PI has the appropriate storage facility for study drugs, including temperature logs," Adams says.
"We help them get their facility ready to conduct clinical research," Adams adds. "We make sure the PI has knowledge about the protocol and processes and clinical practice and is meeting the FDA's requirement for compliance."
The CT site makes certain PIs are trained on policy and procedures and have study coordinators with whom they are comfortable.
"The contract negotiation process will go on at the same time in a different department," Adams says. "We have the contract negotiation and budgeting work going on at the same time."
This way the time-consuming study paperwork process is underway before all of the approvals are in place, she adds.
- Study enrollment begins: "Once we have a strategy, and all approvals are in place, we'll start enrolling in the clinical trial," Adams says. "This may involve a chart review, getting involved actively, having a coordinator in our office talking with patients, and sometimes the coordinator will partner with the clinical office and scheduler to identify potential subjects for the study."
If there's a need for advertising, the CT site has staff handle the ad calls, and full-time recruitment coordinators write the ads and place them with the media, Adams says.
"It's really a team effort to make the CT successful," she says. "The trick in enrolling in CTs is to have an active investigator." Investigators who delegate all active recruitment to coordinators will not be as successful, she notes.
"Sometimes new investigators don't understanding how challenging that will be, and no matter how much you explain it, they'll say, 'This is a lot harder than I thought,' and it doesn't work for them," Adams says. "But those who work in CTs a lot are very successful in recruiting."
- Site director works with investigators and CT staff: "We have an executive site director who works with the investigator and coordinator, and he and the financial director track screening efforts and enrollment efforts weekly," Adams explains. "We keep our finger on the pulse as we go along."
If a coordinator appears to be not making much of an effort or time investment, then the CT site's staff will meet with the coordinator to try to rekindle the coordinator's interest or to troubleshoot problems the coordinator is facing, Adams says.
"We do this in real time because if we let weeks and weeks go by, you'll miss the boat," Adams says. "So it's checked every week through processes that see what kind of activity went on in the screening and recruitment."
The CT site also makes sure study participants are fully protected and that they are compliant with study requirements.
"We have policy and procedures that are in place about how to care for those individuals," Adams says. "We make sure our investigators and coordinators understand the requirements and ensure subjects' safety."