Academic Clinical Trial

Pharmacy Informatics

1. Reported By: Pagdato, Airra Lyn & Quijano, Krysta (GROUP 12) Academic Clinical Trials

2. Clinical Trials

3. Agenda CLINICAL TRIALS 01 . PHASES OF CLINICAL TRIALS 02 . ACADEMIC CLINICAL TRIALS 03 EVERYTHING ABOUT ACADEMIC CLINICAL TRIALS 04

4. CLINICAL TRIALS ALLPPT Layout Clean According to WHO, 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. Text Slide for your Presentation

5. CLINICAL TRIALS ALLPPT Layout Clinical trial in the Philippines is regulated by the FDA FDA CIRCULAR No. 2012-007: Guidelines for Regulation of Clinical Trials in the Philippines Text Slide for your Presentation

6. Recognition of Ethical Review Board/Committee (ERB/ERC) For Purposes of the Conduct of Clinical Trials on Investigational Medicinal Products in the Philippines and for Other Purposes . FDA CIRCULAR No. 2012 - 007

7. PHASES OF CLINICAL TRIALS Population: P atients with less restrictive inclusion/exclusion criteria and longer duration of treatment. Objectives: Confrimation of benefits and risk profile. Characterization of subgroups with different B/R profiles. Confirmation of efficacious doses. Objectives: New indications New formulations Further characterizations of safety. Development in pediatric populations Population: In patients with restrictive inclusion/exclusion Criteria Objectives: Proof of Concept, Dose Ranging, Guidance on Dose and Dosing regimens. For Oncology, Phase 2 may result early approval. Population: Healthy subjects or well controlled patients. Highly refractory patients (oncology) Objectives: Safety Tolerability, Proof of Principle and Determination of Maximum Tolerated Dose. PHASE 1 PHASE2 PHASE 3 PHASE 4

8. Clinical Trials Academic

9. ACADEMIC CLINICAL TRIALS Academic trials or investigator-initiated studies (IIS) are clinical studies conceived, planned, and managed by individual physician–researchers or an academic institution or a group of collaborative clinical researchers or institutions. An academic clinical trials is a clinical trial that is not funded by pharmaceutical or biotechnology company for commercial ends but by public-good to advance medicine.

10. ACADEMIC CLINICAL TRIALS Results of these trials are i ntended solely for academic or research purposes and not for commercial or promotional purpose. It include a wide range of studies – clinical trials of new drugs and real-world prospective or retrospective studies . IIS can help physicians in repurposing of drugs and in investigating health research questions relevant to their practice.

11. SHORTCOMINGS OF ACADEMIC CLINICAL TRIALS AWESOME S LIDE According to studies, it appears that institutions and physicians are not enthusiastic about conducting academic clinical studies. (Bhatt, 2019) This could be due to several challenges – financial, trained workforce, expertise in research methodology

12. GUIDELINES IN CONDUCTING ACADEMIC CLINICAL TRIALS (c) nonmaleficence (d) justice expanded into 12 general principles should be applied to all biomedical, social, and behavioral sciences research for health involving human participants and their biological material and data. These guidelines recommend that while conducting research, the four basic ethical principles such as: (a) autonomy (b) beneficence

13. REASONS FOR FAILURE IN ACADEMIC CLINICAL TRIALS Study design and Selected population By evaluating the potential benefit of their new compound in a low-risk population, these trials were often unable to detect some clinical cure failures or even inferiority as compared with standard care.  . The tight agenda of industry research Industry has a well-defined and tight agenda for a research plan. Drug development takes years, and the patent-restricted period after launching potentially limits the profits that a company can expect. Study site learning curve and clinical coordinating centres numerous potentially eligible patients may present with symptoms or conditions that were not described or considered in the initial proposed protocol.  .

14. POTENTIAL IMPROVEMENTS OF ACADEMIC CLINICAL TRIALS Improve study and ethics committee submission preparation Improve data-monitoring quality and learn from the industry Knowledge of regulatory authorities’ policies and expectations and Establish better agenda Safety reporting not restricted to unexpected events and be multicentered

15. Thank You