3.4a Use Cases for Clinical Research

Study 1 :

Title : Specific Toxicities, Adverse Events, and Hypoglycemia of Various Diabetes Therapies 

Description : The purpose of this retrospective clinical study is to investigate the therapeutic effect of how sugar levels are controlled and to quantify blood sugar levels for each drug. The study will further explore specific clinical outcomes and adverse events associated with diabetes therapies, such as heart failure, renal disease, liver dysfunction, polyps, and weight gain.

Assumption : Sufficient amount patient information is available in the clinical data base(s) to provide the ability to do a power analysis and come up with conclusive evidence to support the hypotheses.

Data Plan : To aggregate patients with diabetes into various defined cohorts, including aggregations based on combinations of number, frequency and duration of diagnosis codes, relevant lab parameters, and the intensity and duration of medications.

Research Requirements : Sufficiently complete data is available in IDR to perform the primary and associated secondary analyses.  These data should include effect modifiers and outcomes, but also elements, such as co-morbidities and demographics that could be used as stratifiers to adjust for confounding.

Conclusion : The pulled and aggregated dataset is suitable for the proposed analysis. The dataset needs to be exported into a structured format that can be studied and plugged into the analytical software*.

Alternative Conclusion : The aggregated dataset is not adequate and suitable for the proposed analysis. The principal investigator is may need to redefine the data search before a new dataset can be pulled.

Study 2 :

Title : The Impact of Avandia® and Other Similar Glycemic Controlling Medications on Cases of Myocardial Infarction (MI)

Description : This is a comparative study to determine if there is an impact on cases of MI and using different types of glycemic controlling drugs such as Avandia, frequently used to control diabetes. A clinical investigator would like to search the available clinical data and compare the use of Avandia and similar drugs on the occurrence of myocardial infarctions (MI).

Assumption : The IDR includes documented cases of MI and the intake of Avandia or other similar therapeutic agents and there is no availability to directly link medication data to disease state.

Data Plan : The Clinical Investigator submits the request specifically naming all drugs and the disease outcome codes under investigation, plus any additional data points needed for the planned aggregated data analyses.

Research Requirements : Sufficiently complete medication data and accurate disease status data are available in IDR to perform the comparative analyses, including the availability of de-identified demographic information and co-morbidities for stratifaction and adjustment purposes. The extracted data needs to be converted and delivered in a format specified by the investigator.*

Conclusion : The Clinical Investigator obtains an aggregated de-identified data set regarding clinical trials or any patient encounters on the use of Avandia and similar medications with any association related to MI. The data set is composed of variables from the IDR which are derived from electronic health record data, clinical trials data and medication data

Alternate Conclusion : Some of the requested therapeutic data are not available at all or incomplete. Based on the specific output results the investigator re-assesses and re-defines the original scientific research plan.

Study 3 :

Title : Randomized Clinical Trial to Compare the Therapeutic Effect of Combination Drugs and Singly Dispensed Drugs in Patients after Coronary Angioplasty

Description : The intent of this study is to compare differences in therapeutic delivery and effects in randomly allocated post-coronary angioplasty patients with high cholesterol and high blood pressure to the 1) regularly prescribed combination drug Caduet®, or 2) separately Norvasc® and Lipitor®, or 3) generic amlodipine and atorvastatin.

Assumption : Data for patients who have just undergone coronary angioplasty are readily identifiable through the IDR.

Data Plan : Over a 12-month period individual patients are identified, who are either scheduled or just have undergone coronary angioplasty, to be randomized into 3 specific study groups. Data to be received should include scheduled date and time of surgery, patient identifiers such as DOB, contact information, surgeon name and other specified demographic data.

Research Requirements : Date and surgery information is readily identifiable and extractable prior to, or immediately after the coronary angioplasty procedure using the clinic IDR. The clinical researcher submits the specified patient data request with proof of all required approvals. The data will be delivered to the investigator in the pre-specified form.

Conclusion : The specified data is extractable and can be made available to the researcher.

Alternate Conclusion 1 : The researcher was not able to provide all the required documentation. The data extraction will be put on hold until the researcher has been able to provide required information.

Alternate Conclusion 2 : The requested information cannot be pulled in the prescribed timely manner. Refer this problem back to the investigator.