Atlanta research company shares tips on promoting quality for growth

Recruitment database tops 8,000 names

Adhering to quality principles and building internal controls for compliance are key factors behind the growth of a successful Southeastern clinical research site.

Clinical Research Atlanta of Atlanta, GA, has grown since 2000 from having one investigator to a staff of 11, and its recruitment database includes more than 8,000 individuals who have agreed to participate in clinical trials.

"We've grown by starts and stops," says Nathan Segall, MD, principal investigator and founder.

"Clinical trials is an incredibly person-driven organization, and you can't rubberstamp anything, although you'd like to," Segall says. "We developed a great deal of oversight in our organization for that reason, and it goes into our improvement process."

Segall explains how the organization has grown successfully and maintained quality, using these strategies:

Recognize industry trends: "We were primarily a respiratory and allergy site, and I recognized six or seven years ago that the robust pipeline in the field of allergy and asthma was beginning to wither," Segall says. "Because our practice is internal medicine, as well as allergy and respiratory, we had an opportunity to do clinical trials outside of my subspecialty."

Stricter regulatory oversight is another recent trend, and this is why the research organization needed to focus on compliance and oversight.

"We moved into a proactive modality as it related to good clinical practice," Segall says.

Learn from mistakes: "We looked at issues of informed consent and issues of quality assurance," Segall says.

For example, the organization found that some prospective participants were misrepresenting who they were to collect the recruitment fee more than once, he notes. "We resolved that by requiring they present a picture ID with their name on it," he says.

To maintain quality in its recruitment process, the organization has incorporated informed consent into every step.

"We look upon informed consent as a process—not a signature and initial on the statement," Segall says. "So from the very beginning of the recruitment process, we inform the individual about the trial, and that information is given to our recruiter."

Also, the site sometimes sends the informed consent document out to prospective participants and asks them to read it and share it with their interested family members, he says.

"We ask them to make notes on the margins of any questions they might have, and when they come in, we can talk with them about informed consent and what the study will involve," Segall explains. "They are then asked to sign the informed consent prior to any procedures being performed, and we document that on the informed consent form.

"Also, there is an informed consent checklist which states that the subject or caregiver has received it and was given ample time to ask questions," he adds.

The study's risks and benefits are explained verbally, and all questions about the informed consent form are reviewed and answered.

If the informed consent form is changed for any reason, then the current version is kept in a clear plastic sleeve, and it's copied and placed in all subjects' charts for the next visit, Segall says.

Focus on quality improvement and training: Quality improvement meetings are held quarterly, and everyone is expected to attend.

When there are changes that occur between meeting times, notices are sent out by e-mail, Segall says.

"We have a yearly training session on site, and we have the staff review the training and standard operating procedures, which are changed on a yearly basis," he says. "Employees complete the training sheet, recertification and certificates, and we capture all of that, and we keep it on file."

Staff training sessions emphasize the organization's core values, which include integrity, culture of learning, and continuous improvement.

"The fourth value is fun," Segall says. "We want employees to think about the work they're doing, and we want them to see themselves developing in a profession."

The organization provides mentoring to new employees, and tasks are divided up so that no one individual has too much work, he says.

Everyone at the organization has human subjects protection certification, including investigators and coordinators, he says.

"If they're not certified, they're expected to certify after meeting the requirement of working two years for full-time, and we pay for them to take the certification test," Segall says.

Principal investigators provide ongoing education to coordinators about the disease processes of each trial, and coordinators are expected to read all adverse event and serious adverse event issues.

Learn from audits: "The sponsor's audit is the best opportunity we have to look at ourselves with great scrutiny," Segall says. "Whenever that happens, we spend 45 minutes to an hour or an hour and a half after the audit with the quality assurance director, the chief coordinator, and the director of operations."

The group discusses what was found, and those involved ask questions and share suggestions. Segall learned from one of these sessions that the organization needed to look at its regulatory documentation in a different context.

"For example, if you have a page Z, which is under a folder in one section, then it could also be in another section, and you'd need to have an index in one of the sections so you could find it in the other one," Segall explains.

"We pay a lot of attention to our regulatory documents and how they are organized," he adds.

Develop better recruitment strategies: "We have a very successful recruitment program that has allowed us to capture demographics on over 8,000 individuals, who are not patients in my practice," Segall says. "I do not use patients in my practice in study trials."

The organization has recruited these individuals through advertising and mailed fliers.

When people call in they are screened by telephone, and all of the advertising and screening process is IRB-approved, Segall says.

"We query people after they are screened for the initial study they called about, and we ask if they would like to be in our database," Segall says. "We inform them that our database is proprietary and it's not sold or used for any purpose except for clinical trials, and we'll inform them from time to time of upcoming trials."

The recruitment process is time-consuming, but it's an unrealized equity because everyone on the database list could potentially be in a clinical trial, he notes.

One employee manages the database, develops recruiting advertising, and seeks IRB approval.

"She is a former nurse and has an MBA in marketing, and we've learned where best to put advertising for certain trials," Segall says. "We're always learning because we tend to experiment with advertising."

When people return calls, the organization collects information about which piece of advertising encouraged them to make the call.