Stuti Agrawal

M.Sc. Clinical Research (2018-2020) Sem-II Roll No.01

Case Study 1
CASESTUDIES
 Dr. Bold - consultant oncologist
 Approached by a research organization that is handling a phase I clinical trial of a
novel drug
 For the treatment of acute small cell carcinoma of the lung
 For a multinational pharmaceutical company based in the US.
 The drug will be tested in a small group of patients with late stage cancer
 Requires the investigator to draw regular quantities of blood amounting to no
more than 800 ml in total over a two-week period
 Full range of haematological, biochemical, pharmacokinetic and
pharmacodynamic parameters can be assessed for safety
 The size of the tumor will also be measured.
 Dr. Bold has background pre-clinical information concerning the drug from
some publications she read several months ago, and thinks the new drug being
evaluated will be a breakthrough in the treatment of cancer.
 Dr. Bold is naturally very keen to be an investigator for the trial and duly
submits an application to hospital's EC for consideration.
Case Study 1 Discussion:
 Dr. Bold plans to become the investigator of a lung cancer phase I clinical
trial.
 The trial requires her to draw regular quantities of blood, amounting to no
more than 800 ml in total over a two-week period.
 800 ml of blood would be drawn from terminally ill cancer patients.
 Normal blood donation of healthy individuals varies from 200 to 550 ml,
depending on the country
 The EC chair could not disapprove the protocol, since that can only be done
by during a full EC review meeting.
 Consulting other ECs involved in the review of the same protocol is in fact
good practice and should be encouraged
Case Study 2

Clinical Research Programs , Gujarat University

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Stuti Agrawal
M.Sc. Clinical Research (2018-2020) Sem-II Roll No.01

 Dr. XX is a consultant psychiatrist specializing in the treatment of patients

with psychiatric illnesses, particularly dementia.
 She has been invited to participate in a trial that aims to examine the blood of
senior citizens with mild senile dementia, looking for genetic markers related
to the illness, as well as examine two established treatment regimes.
 What are the risks / actions one needs to take?
Case Study 2 Discussion
 Potential vulnerability of the trial population
 Trial scientifically sound and of low risk.
 The protocol has to address the informed consent process for tissue sampling
and genetic makers
 The EC would/should accept the protocol under the condition that at least one
legally authorized representative signs the informed consent form together
with the participant, to ensure voluntary trial participation.
 When a potential participant is unable to understand the contents of the
informed consent
 We need to engage a representative for the potential participant in the whole
consent process.
 Children and participants with impaired decision-making capabilities are
examples of potential participants that need to have a representative – a parent,
relative or a caretaker, for instance.
 The informed consent process in such trials should be scrutinized in detail by
the EC
Case Study 3
 Dr. ABC is a qualified and reputed oncologist in the country.
 Company XYZ, approaches Dr. ABC to Conduct a clinical trial in Diabetics
Case Study 3 Discussion
 EC should consider the qualification of Investigator for the proposed trial –
ICH 3.1.3
Case Study 4
 For a clinical trial, PI noted that subjects are not attending the clinic regularly
and hence PI decided to pay to the subjects, only after all visits are completed.
Case Study 4 Discussion

Clinical Research Programs , Gujarat University

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Stuti Agrawal
M.Sc. Clinical Research (2018-2020) Sem-II Roll No.01

 Payments terms should be in Informed consent form

 Payments should be prorated
Case Study 5
 At a site XYZ, there have been several cases where subjects were given wrong
doses of Investigational product.
Case Study 5 Discussion
 First should do questioning with the investigator .
 should call upon a meeting of IRB/IEC and till then keep the trial on hold .
 Staff should be given training again.
Case Study 6
 The Ethics Committee of a site had met and discussed all study related
documents of protocol – ABC dated 04 August 2012.
 The approval letter of EC mentions that “protocol ABC dated 04 August 2012
is approved.
Case Study 6 Discussion
 Documents which were approved, their versions should be clearly mentioned
 Quorum Requirements were met or not, should be reflected in the EC approval
letter.
Case Study 7
 As a member or representative of IRB/IEC (E.C), you are asked to inspect the
site patient’s file.
 During inspection you find signed & dated informed consent form document
which was before the meeting date of IRB/IEC for that particular clinical trial
protocol.
 What will you do as a member of Ethics committee?
Case Study 7 Discussion
 As a member of IRB/IEC, you should ask the investigator to give justification
about this demolition.
 You should also check other ICFs for verification.
 You also need to inform to IRB/IEC about this demolition.
 Also, as it is a big demolition, you should call upon a meeting of IRB/IEC and
till then keep the trial on hold.
Case Study 8

Clinical Research Programs , Gujarat University

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Stuti Agrawal
M.Sc. Clinical Research (2018-2020) Sem-II Roll No.01

 An auditor has come to audit a site that has enrolled 9 patients.

 She finds patient’s original record showing prolonged hospital stay due to HAI
(Hospital Acquired Infection).
 However, there was no CRF filled for an SAE.
 The auditor raises a query to the investigator to which principal investigator
justifies that SAE form was not filled because as per his opinion
hospitalization of the subject is not a direct result of injury due to drug.
Case Study 8 Discussion
 Investigator should fill CRF for SAE, because though it did not happen due to
direct result of injury due to drug but it happened due to his participation in
the trial study. Therefore as described in ICH-GCP guideline investigator
should reported trial related SAE.
Case Study 9
 Chris was recruited to participate in a clinical trial by his oncologist, Dr. Blair.
Chris has cancer, and the traditional treatments have been only intermittently
successful.
 The clinical trial is a randomized, single-blinded, placebo-controlled study of a
drug that may be beneficial to patients with the kind of cancer that Chris has.
 The trial is set to last one year, after which time enough data will have been
accumulated to determine the efficacy of the new treatment.
 Should the EC approve/disapprove the trial?
Case Study 9 Discussion
 Giving cancer patients placebo for one year is not ethical .

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