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250105c FIRST SERIES OF STUDENT RESEARCH GROUP MEETINGS: GROUP #3 9.00-9.55PM 05/01/2024

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Agenda of Meeting with PNU Students prepared by  Prof Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard). 


Time

Sunday

Jan 5, 2025

Monday

Dec 6, 2025

Tuesday

Dec 7, 2025

Wednesday

Dec 8, 2025

Thursday

Dec 9, 2025

7.00pm –

 7.55pm

 

Group 1

Group 4

Group 7

Group 10

Group 13

8.00pm –

 8.55pm

 

Group 2

Group 5

Group 8

Group 11

 

9.00pm –

 9.55pm

 

Group 3

Group 6

Group 9

Group 12

 

  

AGENDA

  • Know one another: self-introductions – 5 minutes
  • The way forward – 5 minutes
  • Presentation of the proposed research program -5 minutes
  • Q&A and open discussion – 30 minutes

 

WAY FORWARD

  • Vision: publish at least 2 papers; the first a review within 6 months and the second based on laboratory or data analysis within 1-3 years.
  • First step: We shall start by brainstorming about the assigned topic, then the group will review the literature to narrow down the topic and develop keywords
  • Second step: Systematic literature review within the group and a 1-hour presentation to Prof Omar once a week or once every two weeks.
  • Third step: familiarization with available laboratory equipment and procedures to prepare one or more research proposals from each group. Faculty will be appointed as supervisors or principal investigators. Students will be co-authors.
  • Some of the research will be new and innovative. Some of it will be attempts at validating research carried out outside the Kingdom.


RESEARCH PROGRAM: PHASE 4 CLINICAL TRIALS FOLLOW UP OF KAAUH PATIENTS ON VARIOUS COMMONLY PRESCRIBED MEDICATIONS FOR EFFICACY AND ADVERSE EVENTS IN PREPARATION FOR NEW PHASE 2 and PHASE 3 CLINICAL TRIALS-1

  • This program will study the efficacy and safety of commonly used licensed drugs and vaccines by phase 4 clinical trials after licensing the drug for use.
  • These are studies of long-term (> 2 years) safety and effectiveness (efficacy and effectiveness, adverse events, toxicity, teratogenicity and birth outcomes), the roles of life-style and genetic factors, and interactions with food and other drugs.
  • Phase 4 clinical trials at KAAUH will provide a long-term ‘real world’ experience of drug performance (efficacy and safety) outside the artificial environment of the phase 3 clinical trials.
  • The results of these studies even in the interim will help change the treatment protocols and even more important will suggest new phase 3 studies with innovative approaches to treatment.


RESEARCH PROGRAM: PHASE 4 CLINICAL TRIALS FOLLOW UP OF KAAUH PATIENTS ON VARIOUS COMMONLY PRESCRIBED MEDICATIONS FOR EFFICACY AND ADVERSE EVENTS IN PREPARATION FOR NEW PHASE 2 and PHASE 3 CLINICAL TRIALS-2

  • Phase 4 studies because of their long-term surveillance will best be based in out-patient clinics that follow up patients on the long-term basis.
  • Consultants in out-patient clinics will each adopt a drug recently approved for use (within the past 5 years) and which is used regularly and on a reasonable number of patients.
  • The consultant in collaboration with pharmacists will select drug-disease combinations for study.
  • Student researchers will abstract, manage and analyze the data under supervision
  • The Health Sciences Research Center will provide data management and data analysis services. It is expected that 15-20 studies will be carried out.


EARCH PROGRAM: PHASE 4 CLINICAL TRIALS FOLLOW UP OF KAAUH PATIENTS ON VARIOUS COMMONLY PRESCRIBED MEDICATIONS FOR EFFICACY AND ADVERSE EVENTS IN PREPARATION FOR NEW PHASE 2 and PHASE 3 CLINICAL TRIALS-3

  • The Pharma manufacturers of the drugs under study will be approached to sponsor the studies since they sponsor similar studies overseas. Sponsors provide protocols, forms, training, monitoring, and funding.
  • Unsponsored studies will be funded by the university or government agencies such as RDIA and SNIH
  • An adequate sample size is needed to detect rare adverse events. Some studies will be made multi0-center to assure adequacy of the sample size.
  • Data collection will mostly be from the clinic electronic records (prospective and retrospective; but additional data will be collected directly from the patient at each clinic visit or by phone. Case report forms will be constructed and tested for each study.  

 

INITIAL REVIEW ARTICLES

  1. Chen B, Haste N, Binkin N, Law N, Horton LE, Yam N, et al. (2023) Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era. PLoS ONE 18(4): e0275356.
  2. Ana Eliza Garcia Ralise , Tais Mendes Camargo, Fernando Augusto Lima Marson.. Phase 4 clinical trials in the era of the Coronavirus Disease (COVID-19) pandemic and their importance to optimize the COVID-19 vaccination, Hum Vaccin Immunother. 2023 Aug 1;19(2):2234784
  3. Xinji Zhang , Yuan Zhang , Xiaofei Ye , Xiaojing Guo , Tianyi Zhang , Jia He. . Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry. BMJ Open. 2016 Nov 23;6(11):e010643.
  4. Bruno Mario Cesana , Elia Mario Biganzoli. .Phase IV Studies: Some Insights, Clarifications, and Issues. Curr Clin Pharmacol. 2018;13(1):14-20