Pharmacy Informatics

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

2. Clinical Trials

3. Agenda
CLINICAL TRIALS01
.
PHASES OF CLINICAL TRIALS02
.
ACADEMIC CLINICAL TRIALS03
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.
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5. CLINICAL TRIALS
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Clinical trial in the Philippines is
regulated by the FDA
 FDA CIRCULAR No. 2012-007:
Guidelines for Regulation of
Clinical Trials in the Philippines
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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
N o . 2 0 1 2 - 0 0 7

7. PHASES OF CLINICAL TRIALS
• Population: Patients 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 intended 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
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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