Brief introduction to clinical trial

1. Clinical trial
Shreekrishna K,
Centre for Human Genetics,Bengaluru

2. Outline
• What is clinical trial?
• Types
• Phases
• Inclusion and exclusion criteria
• In cancer

3. What is clinical trial?
• A clinical trial is a biomedical or health-related RESEARCH studies in
HUMAN beings that follow a pre-defined PROTOCOL.
• Clinical trials are research studies that involve patients or healthy
people and are designed to test new treatments.
https://www.curefa.org/pdf/research/2016FARA-
UCLAsymposiumDrugDevelopmentClinicalTrials.pdf
http://www.ukcrc.org/wp-
content/uploads/2014/03/iCT_Booklet.pdf

4. They aim to find the best ways to:
• Prevent disease and reduce the number of people who become ill
• Treat illness to improve survival or increase the number of people
cured
• Improve the quality of life for people living with illness, including
reducing symptoms of disease or the side effects of other treatments,
such as cancer chemotherapy
• Diagnose diseases and health problems.

5. Who design clinical trial?
• Clinical trials are designed by doctors and other specialists with input
from a wide variety of people, increasingly including patients
• systematic review
• Doctors, nurses, patients and researchers work together with
statisticians, trial managers and representatives from pharmaceutical
companies if relevant, to design the best possible trial. The design for
the trial forms the basis of the trial protocol.
• When the trial protocol is ready it is sent to a research ethics
committee, an independent group of people that includes doctors,
nurses, other medical staff, members of the public and sometimes
lawyers. They decide whether the trial is ethical.

6. Eligibility criteria
• The inclusion criteria :
help the researchers to decide who can take part in the trial. Some
trials only include people in a certain age group, or of one sex, or at a
particular stage of their illness.
• The exclusion criteria:
state who cannot take part in the trial. For example, many drug trials
do not allow pregnant women to take part as there may be a risk to the
unborn baby. People who are already taking particular medicines may
also be excluded as these may affect the trial treatment.

7. Phases of clinical trial
• Phase I clinical trials test a new biomedical intervention in a small group of
people (e.g., 20- 80) for the first time to evaluate safety (e.g., to determine a safe
dosage range, and to identify side effects).
• Phase II clinical trials study the biomedical or behavioural intervention in a larger
group of people (several hundred) to determine efficacy and to further evaluate
its safety.
• Phase III studies investigate the efficacy of the biomedical or behavioural
intervention in large groups of human subjects (from several hundred to several
thousand) by comparing the intervention to other standard or experimental
interventions as well as to monitor adverse effects, and to collect information
that will allow the intervention to be used safely.
• Phase IV studies are conducted after the intervention has been marketed. These
studies are designed to monitor effectiveness of the approved intervention in the
general population and to collect information about any adverse effects
associated with widespread use.
https://docs.gatesfoundation.org/documents/clinical_trials.pdf

9. https://www.aku.edu/ctu/Documents/phases.pdf

10. The Central Drugs Standard Control Organization (CDSCO) is
the national regulatory body for Indian pharmaceuticals and
medical devices, and serves parallel function to the European
Medicines Agency of the European Union, the PMDA of Japan,
the Food and Drug Administration of the United States and
the Medicines and Healthcare products Regulatory Agency of
the United Kingdom.
https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control
_Organization

11. https://www.fda.gov/

12. https://cdsco.gov.in/opencms/opencms/en/Home/

13. https://www.pmda.go.jp/english/

14. What are the different types of clinical trials?
• Treatment trials test experimental treatments, new combinations of drugs,
or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who
have never had the disease or to prevent a disease from returning. These
approaches may include medicines, vaccines, vitamins, minerals, or
lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for
diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health
conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve
comfort and the quality of life for individuals with a chronic illness
https://www.curefa.org/pdf/research/2016FARA-
UCLAsymposiumDrugDevelopmentClinicalTrials.pdf

15. Clinical trial – Study design types
• Non-randomised controlled clinical trial designs
• Randomised controlled clinical trial designs
• Parallel group trial design
• Cross-over trial design
• Matched pair trial design
• Withdrawal trials
• Factorial design
https://www.eupati.eu/clinical-development-and-trials/clinical-
trial-designs/

19. Where can we able to find all the
ongoing clinical trials data?

20. https://clinicaltrials.gov/

21. http://ctri.nic.in/Clinicaltrials/login.php

22. http://www.who.int/ictrp/about/en/

23. In cancer: Recently FDA approved drugs
http://cddf.org/files/2018/03/02-Lindsay-Renfro.pdf

26. Thank you……