P8510, Strategic Issues in Healthcare Quality

Grace Kim, GK2401 / Assignment # 1: Individual Applied Learning Paper

Quality Measurement of Clinical Research
My current job is as a clinical research coordinator (CRC) at the Surgery Department of
Columbia University Medical Center (CUMC), which primarily entails ensuring compliance and
patient safety during the conduct of clinical trials and human subject research. The primary
product of clinical research is the successful completion of clinical trials, which is measured as
the target number of patients who have successfully enrolled in and completed treatment as part
of the clinical trial. These clinical trials span those sponsored by pharmaceutical companies,
funded by the federal government National Institutes of Health (NIH), and self-sponsored by the
Columbia University faculty. As a result of the clinical research projects, academic work is also
produced, including publication, papers, and presentations. With acceptance and academic
recognition of the efficacy and safety of the new therapeutic, pharmaceutical and biotechnology
companies present the data from the clinical trials for the Food and Drug Administration (FDA)
regulatory review process in order for the investigational medication to ultimately be approved
for clinical use. The users of the product and service of clinical research are ultimately the
patients, who stand to benefit from innovative medications and therapies that are still under trial
investigation. Secondary users include academic medical institutions, who benefit from the
enhanced reputations they enjoy from offering innovative medications for patients, and
pharmaceutical companies. The users of clinical research define the quality of clinical research in
the following ways: patient safety, compliance with FDA and local Institutional Review Board
(IRB) regulations, and proper documentation of processes.
Structures, Processes, Outcomes

Health Policy and Management

Fall, 2015

The structures that affect the quality of the product and service are the conduct and
organization of the clinical trials, which are overseen by multiple organizations. These
organizations include the clinical trial office I work in and the Clinical Trials Office (CTO) of
Columbia University which oversees all human subjects research at CUMC. CUMC also has an
active IRB, which must approve every research protocol to ensure patient safety and rights.
Companies, which sponsor drug and medical device trials, contract with third party clinical
research organizations (CROs) to monitor sites compliance with FDA and regulatory
requirements. All academic medical centers, involved in the mission of patient care, research and
teaching, must oversee the successful intersection of patient care and academic research. At
Columbia, CUMC oversees clinical research while its affiliated hospital, New York Presbyterian
(NYP), has patient care as its primary mission. CUMC and NYP must constantly collaborate in
order to ensure proper communication and delineation of responsibilities when patients are in
clinical trials.
All of these organizations also implement processes to ensure quality at each step of the
clinical trial. My office has a system of internal reviews and checklists in place to ensure that
every patient visit in every trial is conducted according to FDA and IRB regulations. The CTO
negotiates contracts with the sponsors, including companies and the NIH, and ensures
compliance with FDA regulations. When a CUMC physician-investigator holds an
Investigational New Drug (IND) application, we have reporting requirements. Our office works
with CTO on crucial FDA documents including IND application forms and annual progress
reports. The members of the Columbia IRB insure that patients rights are maintained through
various mechanisms. They review research study protocols, require approval of an Informed
Consent Form (ICF) or a waiver for every research study that involves active patient
participation and poses risks and benefits to the patients, review materials provided to patients,

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and require documentation of patient confidentiality under the Health Insurance Portability and
Accountability Act (HIPAA). The sponsoring companies also have FDA reporting requirements,
and hence they require the CROs to dispatch monitors, who are personnel trained on the
research protocols and compliance requirements, to visit and monitor the sites that are
conducting the research. I often work with the monitors to demonstrate that our site properly
documents informed consent, patient visits, drug dispensation, and patient safety and adverse
events experienced on the study. We are also required to show IRB approval of all important
documents, including the sponsor-provided protocols, informed consent forms, patient materials,
and personnel training. CUMC and NYP also have arrangements to allow for good
communication between the clinical and research teams, to ensure that patients on clinical trials
are appropriately treated. Since clinical teams may not always be aware of the side effects and
interactions that investigational drugs may have with other medications, the research teams must
communicate that information.
The outcomes that result from these processes are patient safety and patient rights.
Patients can have access to new medications with confidence that their safety and rights are of
utmost concern. Thus, more patients would be willing to step forward and participate in clinical
trials. The processes also ensure the integrity of research data. The FDA can have confidence that
the data for investigational drugs, which is provided by the companies and physicians, has been
vetted and confirmed by multiple organizations. As a result, FDA-approved drugs have the
public confidence, with providers willing to prescribe and patients willing to be treated.
Measurements Structures, Processes, Outcomes
For structure, measurement #1 would be comprehensive review. This would be quantified
by a binary variable, whether the clinical trial, at its start and completion, is reviewed by all the
organizations involved. This could be measured by a simple checklist of all the organizations that

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must review the clinical trial, and the clinical research coordinator would check off each
organization as it reviews the clinical trial. Thus, comprehensive review would be measured by
the percentage of clinical trials each quarter that have undergone comprehensive review by all
the organizations involved. Measurement #2 would be measurement of communication between
organizations. This could be quantified by the volume of correspondence (emails, letters, and
other documentation) for clinical trials each quarter. The CRC could keep a folder of all the
correspondence for each trial with a weight for its importance. Official documentation would be
given higher weight than informal emails. Communication would be measured by the
For processes, measurement #1 could be the number of completed checklists for each
organization required to review the clinical trial. Each organization would have a checklist
specific to its responsibilities. For example, our clinical trial office has checklists to ensure
proper documentation of patient visits and drug dispensation and/or therapeutic treatment
administration. The IRB has a checklist to review protocols, approve the informed consent form,
and maintain patient rights and confidentiality. CUMC and NYP could have checklists to ensure
that the clinical and research teams are in communication about patients in clinical trial
protocols. The checklists could include keeping a trial description of the study in the patients
electronic chart, training all the patients primary providers on the study medication, and
notifying the clinical staff of new information about the investigational treatment. Measurement
#2 is the number of regulatory violations and deviations we report to the local CUMC IRB
and/or the FDA upon completion of the study. Anything that deviates from the FDA and IRB
approved protocol, even if a study visit date occurs just one day outside of the protocol defined
window, must be documented. This ensure that patient rights are protected by proper informed
consent for the clinical research study, IRB approval of all patient materials provided, and proper

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documentation that study visits and procedures are performed with utmost regard for patient
safety. The lower the number of violations and deviations, the better.
For outcomes, measurement #1 is the percentage of patients whose adverse events on the
trial, whether serious or not, are properly addressed and documented by the clinical and esearch
teams. Every clinical trial patient must have all adverse events properly documented, even if it is
clear that it is not related to the study medication. Because the data collected during the trial will
ultimately be used to determine side effects of the trial, all events must be documented
accurately. For example, a patient on a new medication for hepatitis B virus may experience
fatigue and a twisted ankle. Though fatigue may be related to the medication, the twisted ankle
most likely is not. Both must be documented and evaluated by the provider. Measurement #2 is
the number of patients who completed a research trial and percentage of patients who did so
successfully in a safe and appropriate manner without undergoing preventable and unanticipated
harm. I believe both metrics are important in order to measure both the volume of patients who
agree to participate in a clinical trial (also a proxy measure of the perceived quality and safety of
clinical research), and the percent who undergo the process safely.
Analysis
Data from these measurements will help our office, CUMC, and NYP conduct clinical
trials in compliance with safety and regulatory requirements. The IOM 6 defines quality care as
safe, effective, efficient, timely, patient centered, and equitable. Since clinical research is a subset
of patient care, we are more concerned with the quality of care being safe, effective, patient
centered, and equitable. However, efforts to meet those quality metrics would hopefully also lead
to efficient and timely care for patients in need of innovative treatments. These measurements
will help quantify whether all the parties involved, patients and organizations, are satisfied and
fulfilled at the completion of a clinical trial.

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