quality in clinical research

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 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 patient’s

electronic chart, training all the patient’s 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


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.


quality in clinical research

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