UNIT-II

CLINICAL DATA

UNIT-II

CLINICAL DATA:

Clinical Data, Application, Challenges, Solutions, Clinical Data

Management System

CLINICAL DATA

• Data pertaining to the medical well-being or status of a patient or subject.• Clinical data is generated out

of clinical trials which is acquired, stored, processed, transmitted and utilized for producing more effective and efficient healthcare solutions.

CLINICAL DATA

• Clinical Trials:• In health care, clinical trials are

conducted to allow safety and efficacy data to be collected for new drugs or devices.• Efficacy: Capacity or power to

produce a desired effect

What is a clinical trial?

• For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

What is a clinical trial?

• Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

Clinical Trials

• Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Clinical Data Management System

• A Clinical Data Management System [CDMS] is used in clinical research to manage the data of a clinical trial.• Any information system

concerned with the capture, processing or communication of patient data.

Clinical Trial Management System(CTMS)

• Some popular requirements include: • budgeting, • patient management, • compliance with government

regulations, and • compatibility with other data

management systems.

Clinical Data Acquisition:

• Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following:

• paper or electronic medical records,

Clinical Data Acquisition:

• paper forms completed at a site,• interactive voice response systems, • local electronic data capture systems,

or• central web based systems.

Secondary use of Clinical Data

Secondary use of health data applies personal health information (PHI) for uses outside of direct health care delivery.

Secondary use of Clinical Data

• Primary use = “direct patient care”• Secondary use = anything beyond primary

• – To communicate to other members of a team• – To support and justify reimbursement• – To satisfy requirements of protocols & systems• Allow systems to derive needed data from that single

instance of recording

• Instead of focusing on “direct patient care”• Secondary uses of clinical data are any uses

other than the primary purpose(s) for which the data is recorded

• Example:• Communicable disease reports to the health

department can be derived from routine lab culture reports, where the primary purpose is communication to the ordering physician, (not epidemic detection).

Why do clinicians record patient data?

• Research protocols• Minimum data sets• Professional guidelines• (? And some incidental constraints imposed by

software)

Secondary Use of Clinical Data

•It includes such activities as –analysis, –research, –quality and safety measurement, –public health, –payment, –provider certification or accreditation, –marketing, and other business applications, including strictly commercial activities.

Secondary Use of Clinical Data

•Secondary use of health data can –enhance health care experiences for individuals, –expand knowledge about disease and –appropriate treatments, –strengthen understanding about effectiveness and –efficiency of health care systems.

Secondary Use of Clinical Data

•Secondary uses of health data can –enhance individuals’ health care experiences,–expand knowledge about diseases and treatments, –strengthen understanding of health care systems’ effectiveness and efficiency, –support public health and security goals, and–aid businesses in meeting customers’ needs.

Secondary Use of Clinical Data

•Benefits

•Benefits include increased simultaneous entry of clinical and research data, increasing the number of subjects and the amount of data collected, ultimately increasing the generalizability of research. In traditional clinical research, data is collected on paper forms separately from clinical documentation, requiring double entry of data.

Secondary Use of Clinical Data

•Benefits

•This adds cost and may limit accuracy if data collection is performed by non-clinical personnel. The number of subjects enrolled and the amount of data collected is limited by cost and time.

Secondary Use of Clinical Data

•Benefits

•If data can be collected simultaneously with clinical documentation, costs can be reduced and data may be more accurate when entered immediately by the clinician caring for the patient.

•More patients can participate in studies and research findings become more generalizable to a diverse population.

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.

These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Clinical research

Clinical Research is different from clinical practice.

In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.

Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety, toxicity if applicable and efficacy, if possible at this early stage) are studied.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

Clinical Data Management assures collection, integration and availability of data at appropriate quality and cost.

Clinical Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

This helps to produce a drastic reduction in time from drug development to marketing.

Clinical trial is intended to find answers to the research question by means of generating data for proving or disproving a hypothesis.

The quality of data generated plays an important role in the outcome of the study.

Often research students ask the question, “what is Clinical Data Management (CDM) and what is its significance?”

CDM is a relevant and important part of a clinical trial.

All researchers try their hands on CDM activities during their research work, knowingly or unknowingly.

Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

This helps to produce a drastic reduction in time from drug development to marketing.

Team members of CDM are actively involved in all stages of clinical trial right from inception to completion.

They should have adequate process knowledge that helps maintain the quality standards of CDM processes.

Standard Operating Procedures

Standard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines

Data management plan

The data management plan describes the activities to be conducted in the course of processing data.

Case Report Form:

The Case Report Form (CRF) is the data collection tool for the clinical trial and can be paper or electronic.

A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research.

The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site.

All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

Paper CRFs will be printed, often using No Carbon Required paper, and shipped to the investigative sites conducting the clinical trial for completion after which they are couriered back to Data Management.

Electronic CRFs enable data to be typed directly into fields using a computer and transmitted electronically to Data Management.