Preclinical Research & Clinical Research Training

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Preclinical Research Norms Requirements

• Made by-
• Shreya Gupta
• Clariwell Global services

2
Introduction to Preclinical Research

• Even before a drug could be tested in a clinical
  trial, the development process of a drug
  generally involves three major steps, including
  discovery, preclinical development, and then
  clinical trial. The transition from discovery to
  preclinical development is an ongoing process.
  The results obtained from toxicology and
  preliminary pharmacology testing often contribute
  to candidate selection for a drug. The filing of
  an Investigational New Drug (IND) sets up a
  boundary between preclinical development and
  clinical research of a drug.
•  

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The following international organizations ensure
drug safety and efficacy

• World Health Organization (WHO),
• Pharmaceutical Inspection Co-operation Scheme
  (PIC/S),
• International Organization for Standardization
  (ISO),
• International Conference on Harmonization (ICH),
• Parenteral Drug Association (PDA), and
• International Society for Pharmaceutical
  Engineering (ISPE).
• Take Best Clinical Research Training

4
Some of the national regulatory bodies issuing
guidelines for drug development include

• European Medicines Evaluation Agency (EMEA),
  Europe
• Food and Drug Administration (FDA), US
• Regulatory Operations and Enforcement Branch of
  Health Canada (ROEB), Canada
• Pharmaceuticals and Medical Devices Agency
  (PMDA), Japan
• Medicines and Healthcare products Regulatory
  Agency (MHRA), UK
• Brazilian Health Regulatory Agency (ANVISA),
  Brazil
• Therapeutic Goods Administration (TGA), Australia
• Turkish Medicines and Medical Devices Agency
  (TMMDA), Turkey
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Should clinical trials be conducted locally?

• A common question that often comes to mind is
  whether clinical trials are required to be
  conducted locally as a stated or implicit
  condition to obtain marketing approval. The
  majority of countries, including India, require
  clinical trials to be conducted locally as a
  pre-condition for obtaining marketing approval.
  It is done to prove the safety and efficacy of a
  drug or medical device that satisfies the
  definition of a new drug and investigational
  medical device, respectively. Learn Best Clinical
  Research Course.
• However, if the investigational medical device
  has been imported from the United States of
  America, the United Kingdom, Australia, Japan,
  Canada, or the European Union, then the
  requirement to conduct a clinical trial locally
  can be waived off if a free sale certificate is
  obtained and submitted from the relevant
  jurisdiction. Take Best Clinical Research
  Training.

6
How are clinical trials funded?

• Irrespective of where the sponsors are
  incorporated, clinical trial sponsors can
  directly fund a clinical trial. The sponsors are
  responsible for choosing a team of investigators
  and a physical investigator who then leads the
  team of investigators. The sponsor of a clinical
  trial can directly pay the investigators for
  their services. The sponsor is also permitted to
  make payments for the site, also selected by the
  sponsor, for the clinical trial for providing
  in-patient facilities, among various others. In
  case of investigators being the site employees,
  the sponsor can make direct payments to the site,
  which is later redistributed to the investigators

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Requirements for preclinical and clinical trial
norms

• Clinical trials run only after approval of a list
  of preclinical trial norms and protocols.
  Different national and international laws govern
  these norms and protocols. In India, The
  Prevention of Cruelty to Animals Act, 1960 (PCA
  Act) and The Breeding of and Experiments on
  Animals (Control and Supervision) Rules, 1998
  (BEACS Rules) framed under the PCA Act regulate
  the preclinical trials or studies on animals. The
  BEACS Rules states that any protocol for
  preclinical trials must ensure that animals first
  considered for any experimental procedure should
  stand lowest on the phylogenetic scale, which may
  give scientifically valid results. The experiment
  should be so designed that a minimum number of
  animals are used to give statistically valid
  results, establishing a 95 percent degree of
  confidence. Take Best Clinical Research Training.

8

•  
• Before experiments can be conducted on animals,
  experiment-specific permission is required from a
  designated committee or authority. As regulated
  by different laws regulating preclinical trials
  across the world, some of the crucial
  requirements include study rationale, study
  design, subject eligibility, study treatment, and
  background of the principal investigator.
  Generally, an ethics committee is also set up to
  review and approve the clinical trial prior to
  its operations commencement. The ethics committee
  is also responsible for reviewing and approving
  any changes or updates made to the clinical trial
  protocols prior to their implementation. However,
  prior approval from the ethics committee is not
  required when the implementation of updates is
  necessary for patients' health and safety.

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Preclinical research

• Before a drug or treatment can be tested on
  people, clinical researchers should ensure
  whether it can cause potential risks, side
  effects, or serious harms, also known as toxicity
  to the patients. The two types of preclinical
  research include the following 
• In Vitro
• In Vivo
• In the US, the FDA stipulates that researchers
  must use good laboratory practices (GLP), as
  defined in medical product development
  regulations for preclinical laboratory studies.

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The GLP regulations set the minimum basic
requirements for

• study conduct
• personnel
• facilities
• equipment
• written protocols
• operating procedures
• study reports
• It also establishes a system of quality assurance
  for each preclinical study to ensure the safety
  and efficacy of products approved and regulated
  by the FDA. Generally, preclinical studies are
  not conducted on a very large scale. However,
  these studies must provide detailed information
  on dosing and toxicity levels. Clinical
  researchers review their results after
  preclinical testing.

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Conclusion

• Preclinical studies encompass various activities
  that serve as a link between drug discovery and
  preparation and the initiation of a clinical
  trial on humans. The laws regulating preclinical
  trial norms and requirements worldwide can
  package differences but generally have some
  common features. Rodent and non-rodent mammalian
  models are generally used to set forth general
  safety and identify toxicity patterns that reveal
  potential target organs likely to suffer the
  adverse effects. Take Best Clinical Research
  Training. Toxicology and safety studies also
  identify Therapeutic Index for deciding the
  initial starting doses in clinical trials. More
  than one or more species can be used for
  determining the drug's mean residence time in the
  body. The mean residence time of a drug in the
  body depends on inherent absorption,
  distribution, metabolism, and excretion
  properties.