7. from the participants. Achieving informed consent

 

 

7. The
process of achieving Informed Consent from the participants.
Achieving informed consent is a process that begins when initial contact is
made with the prospective participants and continues throughout the course of
the study. The investigator must put effort to improve the comprehension of the
participants. By informing them, by repetition and explanation, by answering
their questions as they arise, and by ensuring that each individual understands
each procedure, investigators obtain the informed consent of the participants.
Each individual must be given as much time as is needed to reach a decision,
including time for consultation with family members or others (Association
of Clinical Research Professionals, 2013). Prospective
participants who are vulnerable or lack decision making capacity must receive
particular attention. Subsequently, the investigator must assess the decision
making capacity of the prospective participant by employing, for instance, a
questionnaire. Finally, the prospective participant, the legal representative
or consultee must be allowed to make a free and voluntary decision to participate
or withdraw by minimizing possible coercion or undue influence. The informed
consent is formally sealed with the signature of the participant, the legal
representative or consultee and the researcher who carried out the process (Adom Agyeman
& Ofori-Asenso, 2017).

The
ethical issues when selecting human subjects for the Phase I study.
Phase I or First in Human (FiH) trials raise a couple of ethical issues. An
ethical standard is that clinical trials require to have a favourable
risk-to-benefit ratio. Participants also must be protected from excessive risks.
But, both of these standards may be difficult to assess and to achieve in FiH
trials. There are no widely accepted standards for judgments concerning risk,
benefit, and value in FiH trials. Also, the question of how to conceptualize the
benefits has been a subject of ethical debate for FiH trials. The chance of
therapeutic benefit to participants can be very small while they are being
exposed to a ”possibly” high level of risk. Then, there is the question as to
how to communicate accurate and meaningful information about the uncertainty,
risk of adverse events, and the informed consent process. The fact that FiH
trials mostly enrol participants with serious unmet needs, complicates the
process further (Chapman, 2011). The main purpose of
clinical trials is after all to ”study” new medical products in people.
Therefore, it is important for people who are considering participation in a
clinical trial to understand their role, as a ”subject of research” and not
as a patient  (FDA, n.d.).

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(Arrien Pharmaceuticals, 2017) (Centre Hospitalier Universitaire Vaudois,
2015)

·        
Unable to communicate or cooperate with the investigator.

·        
History or a positive test result for hepatitis B, C, or HIV infection.

·        
Treatment in any drugs that are inhibitors of cytochrome P450 (CYP) enzymes
within 30 days prior to study and that may have an impact on the safety of the
subjects and validity of the study results.  

·        
Use of any medication in 2 weeks prior to study and
throughout study.

·        
Participation in another clinical trial within 30 days prior to the study.

·        
Smoked or used nicotine-containing products within 30 days prior to the study.

·        
Clinically significant abnormal finding on the physical exam, medical
history, ECG, or clinical laboratory results.

·        
Blood (500 mL) donation or haemorrhage during the
previous 3 months

·        
History of alcohol or drug abuse within the past 2 years.

·        
History of cardiac, immunologic, renal or any other major diseaes that would likely have
interfered with the absorption, disposition, metabolism, or excretion of the study
drug.

Exclusion Criteria:

 

·        
Results of liver function tests within normal range.

·        
Results of hematology tests within normal range.

·        
Vital signs of subject must be within the following ranges: heart rate:
40-100 beats per minute; systolic blood pressure: 90-145 mmHg; diastolic blood
pressure: 50-95 mmHg.

·        
Subject is willing and able to remain in the study for the entire study
period and returns for an outpatient visit 7 days after study treatment
administration.

·        
Provided informed consent.

·        
Body Mass Index (BMI) between 19 and 30 kg/m2.

·        
Aged between 18 to 55 years.

Inclusion Criteria:

Cohorts:
Group 1:              12 active + 4 placebo
Group 2:              12 active + 4
placebo
Group 3:              12 active + 4
placebo
Group 4:              12 active + 4
placebo

Subjects must
be aged between 18-55. The reason for choosing this age group is because people
can develop the disease at any age (Pietrangelo & Higuera, 2015). Due to safety
concerns, women are excluded from participation in this phase I trial. Lastly,
we do not make a distinction in ethnicity  (Travis, 2004).  

3. The
characteristics of the study population.
A randomised, placebo-controlled, safety, tolerability, dose escalation,
pharmacokinetic study of various doses of subcutaneous SAL97 (anti-?4?1integrin)
will be conducted in 64 healthy male volunteers. We need healthy volunteers to
help us define the limits of ”normal”. Healthy volunteers can provide the
”cleanest” data. Using a patient can be difficult to separate the effects of
a study intervention from the effects caused by the disease or medications of
the patient. Healthy people can also tolerate adverse effects from the
experimental interventions more easily than patients can. The reason is because
drug toxicity can exacerbate the existing medical problems of patients (Dresser,
2009).

The aim of Phase
I clinical trials are to determine the safety, tolerability and
pharmacokinetics of a compound.

 

B1 Clinical Development:
Phase I & GCP