Embedded Files
Randomized Clinical Trial of a Drug Title of study: Comparison of a new drug [A] with an existing drug [B} used in treatment of disease X Principal investigator: Dr. ABC Institute: Department of Pediatrics, Aga Khan University Introduction: I am Dr. [SAK] from Department of Pediatrics, the Aga Khan University and doing a research on treatment of disease [X, for example malaria]. There is a new drug [A] which is being recommended for its treatment. I want to see if the new drug [A] is as good as or better than the commonly used drug [B] for the treatment of disease [malaria]. Since you are a patient of (or suffering from) disease [malaria], I would like to invite you to join this research study. Background information Disease X (Malaria) is a common disease in Pakistan, Asia and Africa, caused by a germ (parasite) spread by mosquito. It causes high grade fever. Some patients may have complications and even die. The commonly used drugs are losing their Inclusion • Persons between the ages of 18 and 65 • Persons weighing between 50 and 100 kg • Persons on a stable dose (i.e., no dose change in the previous 3 months) of cardiac medications (e.g., anticoagulants, angiotensin-converting enzyme inhibitors [ACEIs], angiotensin II–receptor blockers [ARBs], beta blockers, and diuretics) • Persons adhering to a no-added-salt diet Exclusion • Women who are pregnant or nursing • Women of childbearing age who do not use oral contraceptives • Persons with symptomatic cardiac disease, hepatic dysfunction, chronic kidney disease, neurologic disorders, or musculoskeletal disorders • Persons with clinically significant abnormal laboratory values (chemistry and hematology) Commented [SL10]: It is best to not have just one thirdlevel (H3) head under an H2. Subheads should be deployed in a set of two or more for clearer digital lesson creation. Because “Informed Consent” was an existing H3 below, an H3 was added here, “Autonomy,” to align with the key term. (p. 8) Third-level (H3) heads do not require an associated learning objective. However, these headings help chunk the content so that students are better able to parse it. In addition, these headings help the digital team better understand important concepts in creating digital instruction, exercises, and assessments. (p. 8) Commented [SL11]: Use of a bulleted list here helps students more easily retain information. (p. 14) Commented [SL12]: As is the case with figures, boxed features should be placed as near as possible to their intext reference. (p. 18) Commented [SL13]: The boxed feature works well by chunking content into two separate categories: Inclusion and Exclusion. (p. 11) 4 effectiveness and germs are getting resistant to it. A new drug known as [A] is supposed to be effective in treatment of disease (malaria) but there is not enough evidence that it is as good as other drugs used for treatment of disease (malaria). Purpose of this research study The purpose of study is to find out if the new drug is as good as or better than other drugs used for treatment of malaria in our population and; also to see if germs are not resistant to it. Procedures In this study, all patients aged 15 to 50 years of age, presenting at the clinic with fever for less than one week duration and having no other diagnosis will be registered and screened for malaria. For diagnosis of disease (malaria), one ml of blood will be taken from the patients and checked for presence of germs (malarial parasite). Those patients having positive test for the disease (malaria), will be included in the study. They will be divided randomly in to two groups by a computer draw. One group will get the new drug (A) and the other group will get the commonly used drug (B). Neither the doctor nor the patient will know which drug he/she is getting for treatment of his/her disease. A record will be kept for the duration of fever and other symptoms including any other side effect. Other necessary treatment will also be provided if needed. Possible risks or benefits No significant side effects have been reported for this new drug (A). However, some patients may feel nausea or may have vomiting. Drawing of blood may cause some discomfort or blue discoloration at the site of bleeding. Lowering of white blood cells
Report abuse