Key to reducing clinical trial costs might be found in enhanced coding

Coding expert offers suggestions

Clinical trial administrators, sponsors, and investigators could greatly improve trial efficiency, cut costs, and improve communication between all parties involved if they were to make consistent use of existing medical coding systems and add new coding systems designed specifically for research, a clinical research expert says.

"A lot of the big issues between sponsors and sites are hidden costs," says Norman Goldfarb, managing partner of First Clinical Research in Palo Alto, CA. Goldfarb has spoken about coding and metrics in clinical trials at various clinical research conferences, and he recently completed several sets of codes that could be used by clinical trial sites and research sponsors.

"So when the sponsor puts a high price in the study budget for the history and physical, they’re paying a lot for that, but it’s like the metaphor of paying a lot for the freezer but getting the refrigerator for free," Goldfarb says.

One of the significant hidden costs of clinical trial research is the staff time that’s involved in returning to the sponsor repeatedly to clarify items on the study protocol, Goldfarb explains.

For example, a protocol may say simply that an endoscopy will be performed. Since there are many different kinds of endoscopies, the investigator or clinical trial staff will typically have to call the sponsor to ask for a clarification, Goldfarb says.

"Getting a precise answer can take a couple of days," he says. "Although that is determined at the beginning of a study before the subjects are enrolled, it can slow down the budget negotiation because the investigator doesn’t know how to price the budget without knowing precisely which procedure is expected."

Throughout a clinical trial process, there are similar instances when something in the protocol is not precise and needs clarification that costs clinical trial staff and investigators unnecessary time.

The solution would be for the sponsor to specify a CPT (Common Procedural Terminology) code with the endoscopy, and this procedural code would tell the investigator/physician precisely what needs to be done, Goldfarb says.

Since all physicians use the CPT codes for billing of procedures and the ICD-9-CM (International Classification of Disease, Ninth Revision - Clinical Modification) codes for diagnoses, it would be a simple matter to have investigators use these when interpreting protocols, Goldfarb notes.

By using ICD-9-CM codes, a trial site could improve its enrollment process by checking potential subjects’ diagnosis codes against the codes described in the exclusion/inclusion criteria, Goldfarb says.

"By listing CPT and ICD-9 codes, the sponsor can communicate much more accurately to the site exactly what they want sites to do," he adds.

This is a first step to introducing greater clarity and improving efficiency in the clinical trial process. However, Goldfarb has developed additional coding systems that would further improve quality and reduce hidden costs, which would help to improve research nationwide.

"In my opinion, we could cut the costs of clinical research by half if we put our minds together, and we could take a year out of the clinical research process, which is 5.7 years on average now," Goldfarb says. "We could improve the quality of data by a factor of five, and we could double subject satisfaction."

Here are his suggestions for additional ways to improve quality and efficiency in clinical trials:

1. Improve communication and site/sponsor understanding.

Misunderstandings create problems and waste time, but these often could be prevented through the use of coding in clinical research, Goldfarb says.

To start, clinical trial sites could use CPT and ICD-9-CM codes, which already exist and would give clarity and precision to many different procedures and services provided during the course of a clinical trial, Goldfarb explains.

"All sponsors have to do is call a doctor or check the Web to find the right code," Goldfarb says.

Another method for improving communication would be to create a common lexicon for research, expressed in codes. Goldfarb has created a directory of Clinical Research Terminology (CRT) codes as a lexicon for understanding and communicating investigative site research activities.

Here are some sample CRT codes:

Recruiting and Prescreening Activities

  • R1100 — Recruiting Plan, Develop & Track
  • R1110 — Recruiting Materials, Create
  • R1111 — Recruiting Materials, Distribute
  • R1112 — Recruiting Materials, Mail
  • R1120 — Referral Sources, Identify, Recruit & Manage
  • R1140 — Telephone Inquiries, Answer
  • R1141 — Prescreen Potential Subjects, Telephone
  • R1142 — Prescreen Potential Subjects, In-person
  • R1143 — Review Charts for Potential Subjects
  • R1144 — Set-up Subject Recruitment Firm
  • R1145 — Submit Status Logs to Subject Recruitment Firm
  • R1146 — Coordinate with Subject Recruitment Firm

2. Use Clinical Research Assessment (CRA) codes.

"What happens is the protocol will ask for XYZ assessment, and you say, I’m not familiar with that assessment, and the sponsor has not provided instructions for it,’" Goldfarb says. "So you have an issue with whether it’s something you’re qualified to do or how to price it or how long it will take." This common scenario will result in a call to the sponsor, who may take days to answer in the necessary detail, Goldfarb adds.

The solution would be for the sponsor to use a CRA code in the protocol or for the clinical trial site to ask the sponsor if a particular CRA code would fulfill the protocol requirements, he says.

Goldfarb has listed 141 CRA codes that are available to any research organization for free use. They can be downloaded from his Web site at www.firstclinical.com.

Here are some sample CRA codes that Goldfarb has listed:

Cardiology

  • AB — Angina Battery
  • APQLQ — Angina Pectoris Quality of Life Questionnaire
  • BUPA-CRA — BUPA Coronary Risk Assessment
  • CARDARRH — Cardiac Arrhythmias
  • KCCQ — Kansas City Cardiomyopathy Questionnaire
  • MLHF — Minnesota Living with Heart Failure Questionnaire
  • SAQ — Seattle Angina Questionnaire
  • VQOL — Vascular Quality of Life Questionnaire

3. Agree in advance on protocol deviations and violations.

Clinical trial sites often have questions about classifying and reporting protocol deviations or violations, Goldfarb says. "They either make their best guess or they contact the sponsor or IRB and say, What would you like us to do?’" Goldfarb says. "So there’s time wasted and errors made."

The solution is to list every possible type of deviation and violation, he says.

There likely will be classifications that are unique to a particular study, but most will be standard. Goldfarb has created 120 codes for deviations and violations or events that are neither.

"Let’s say the study subject was given medication, and he took the medication two hours before he was supposed to, and you don’t know if that’s a deviation or violation or nothing," Goldfarb explains. "You could refer to the deviations and violations directory and see how it’s classified."

Then the study coordinator would make a note in the documents with that code and check this code against the IRB’s instructions for how to handle various deviation and violation incidents, Goldfarb adds.

This coding system also provides the site, sponsor, and IRB with an opportunity to track violations and deviations as they occur to see if there’s a pattern that needs to be addressed, Goldfarb says.

"You can start to keep statistics on it and work to improve performance," Goldfarb says. "If sponsors see that some sites are having a lot of problems with a particular deviation, they can provide training at investigator meetings."

The entire process of identifying problems becomes systematic and enables clinical trial sites to adapt training to focus on real and frequent problems instead of potential and possibly infrequent problems, he says.

Here are some sample Protocol Deviation & Violation codes created by Goldfarb:

Exams

  • P1401 — Exam incorrect: Violation
  • P1402 — Exam not attempted: Violation and Deviation; violation if safety issue
  • P1403 — Exam unsuccessful: Deviation
  • P1404 — Extra exam performed: Violation
  • P1405 — Exam prior to window: Deviation; violation if safety issue
  • P1406 — Exam after window: Deviation; violation if safety issue
  • P1407 — Exam data lost: Deviation
  • P1408 — Exam performed by someone not on 1572 (if required): violation

4. Use codes in IRB proposal and for billing sponsors.

Contract research organizations also need codes that are specific to their tasks of submitting RFP proposals and billing sponsors for services, Goldfarb says.

Goldfarb has created 150 codes for clinical research services. Here is a sample of Clinical Research Service (CRS) codes:

Project Management Activities

  • S1010 — Project Management Plan, Develop
  • S1011 — Internal Team, Manage
  • S1012 — Communicate with Sponsor
  • S1013 — Communicate with Sites
  • S1014 — Status Reports, Generate
  • S1015 — Kick-Off Meeting, Plan
  • S1016 — Joint Project Management Team Meetings at Sponsor, Participate in
  • S1017 — Joint Project Management Team Meetings at CRO, Participate in
  • S1018 — Sponsor Teleconferences, Participate in
  • S1019 — Project Management, Other

"I got the idea for these from a Pharmaceutical Outsourcing Management Association project," Goldfarb says. "They’re doing a project to create a standardized template for requests for proposals, so a key ingredient is a standardized set of activities."