Questionnaire on Clinical Research
Q 1. Explain Clinical Research?
Ans. Clinical research refers to any kind of investigation in human subjects which aims to discover or check the clinical,pharmacological,and other pharmacodynamic effects of an investigational product.
Q 2. Explain various types of clinical trials?
Ans. Clinical trials can be of several types. These are as follows:
New approaches of prevention trials test like medications, vitamins, or other supplements which according to doctors may can lower the risk of development of a certain type of cancer. Generally the prevention trials are conducted with healthy people with no cancer history. Certain trials are also conducted with people who have cancer and want to reduce the chance of developing a new type of cancer or returning of cancer.
Diagnostic trials are conducted usually on people who shows signs or symptoms of cancer whereas treatment trials are conducted with the people who actually have cancer. They answer certain questions and effectiveness of new treatment or a new way of using a standard treatment is judged. These trials test treatments such as new drugs, new approaches to surgery or radiation therapy, vaccines, or new combinations of treatments supportive care (also called Quality-of-life) trials explore ways to improve the comfort and quality of life of cancer patients and its survivors. These trials will be helpful in the study of treatment of patients experiencing nausea, vomiting, depression, sleep disorders, or other effects from cancer or its treatment. To detect cancer earlier screening trials are done and are often conducted to determine whether finding cancer at early stage of symptoms decreases the chance of dying. These trials include people who do not have any signs of cancer. Diagnostic trials study could be used to identify cancer more accurately. They are sometimes part of another cancer clinical trial. The genetics component of the trial also focus on how genetic makeup can affect diagnosis, detection, or response to cancer treatment.
Q 3. Explain Clinical Trials ?
Ans. There are Five phases of clinical Trials
Pre-clinical, animal tests and In vitro (test tube), to determine dosing and any other potential risks to administration in the human beings.
Phase One,The determination of safe doses of a new drug by trials on healthy human volunteers and the drug’s effect on the body (pharmacodynamics) and the body’s effect on the drug (pharmokinetics). Often performed by CROs (Contract Research Organisations) or in large teaching hospitals.
Phase Two, Treatment or the experimental drug is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.
Phase Three, Studies with large numbers of patients undertaken by GPs or in hospital. Comparing of the efficiency and side effects of the drug with existing placebos and treatments.
Phase Four, Is performed after the product licence has been granted by the regulatory authorities. Industry conducts large, long term epidemiological studies to assess optimal use and for the marketing strategy of the drug these are essential. Safety (pharmacovigilance) is monitored by post marketing surveillance studies.
Q 4. Why SAP is important?
Ans. SAP is the document that contains detailed information regarding the statistical methods and study objectives to help in the production of the Clinical Study Report (CSR) including figures, summary tables, and subject data listings for Protocol. Documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis are also contained in this.
Q 5. What do you understand by CRT?
Ans. CRT means Case Report Tabulation. CRT’s are sent to the FDA whenever a pharmaceutical company is submitting an NDA.
Q 6. What are all the PROCS you know?
Ans.I know about many procedures like proc sort, proc report, proc format etc. I have generated the list report using the proc report; in this procedure I used subjid as order variable and sbd, trt_grp, dbd as display variables.
Q 7. Explain Verification?
Ans. Verification ensures the accuracy of the final tables and the quality of SAS programs which generates the final tables. I selected the subset of the final summary tables for verification according to the instructions SOP and SAP.
Q 8. Tell about domains/datasets you have used in your studies?
Ans. Medical History, ECG, Labs , Demog , Physical Exam, Adverse Events ,Vitals etc
Q 9. Give examples of edit ckecks you made in your programs?
Ans. Demog: Body mass index is below expected and Weight is outside expected range
( check weight and height). DOB is greater than the Visit date or not.the Gender value is a valid one or invalid. Age is not within expected range.
Visit Start is before birthdate or Stop is before the start. Study medicine discontinued due to the adverse event but completed
Result is within the normal range and also abnormal is not blank or the case can be ‘N’Result is outside the normal range and also abnormal is blank.
Diastolic Blood pressure more than Systolic Blood Pressure
Visit date prior to Screen datePhysicalPhysical exam is normal and also comment included.
Q 10. Tell about LOCF?
Ans. Pharmaceutical companies spend several months to conduct longitudinal studies on human subject. It is unrealistic to expect patients to keep timely visit over such a long period of time. Despite all the efforts, patient data are not collected for some and these become missing values in a SAS data set later. For reporting, the most recent previously available value is substituted for each of the missing visits. This is known as Last Observation Carried Forward (LOCF).LOCF doesn’t mean the last SAS dataset observation which gets carried forward rather it means last non-missing value carried forward. It is the values of individual measures which are actually “observations” in this case. Also if there are multiple variables containing these values then they will be carried forward independently.
Q 11. Explain CRM ?
Ans. CRM means Clinical Research Managers. They supervise informed consent forms for clinical trials, case report forms and design and writing of protocols. CRM ensures that Case Report Forms are reviewed timely and submitted to the data management group.