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Recruitment of Healthy Volunteers

CME presentation
by

william KB

on 4 January 2013

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Transcript of Recruitment of Healthy Volunteers

1. The definition of healthy volunteer
2. The process of recruitment
3. The need of healthy volunteers
4. Motivation for volunteering
5. Ethical concerns
6. Risk and benefit
7. Right of volunteering Content Healthy Volunteer 7. Free of any drug allergy, etc. How do we approach them What type of study that needs healthy volunteers Dose finding, Pharmacokinetics,
Pharmacodynamics, drug interaction, etc Recruitment of Healthy Volunteers by William.Law An introduction about William *A registered pharmacist
* Graduated from USM, Penang in 2006
* Completed my professional training in 2007 at Hospital Sultanah Aminah (HSA), JB
* Worked as a clinical pharmacist at Hospital Sultan Ismail (HSI), JB for two years
* Joined Clinical Research Centre (CRC) National in 2010 and involved in planning and setting up early phase clinical trial unit.
* In 2011, being placed at Hospital Ampang to manage clinical trial and CVM unit, until now An introduction about William I have a 10 months old baby named Nicol ! An introduction about CRC-Veeda-Malaysia Unit In 2011, a Memorandum of Agreement (MoA) was signed by Ministry of Health and Veeda Clinical Research to spearhead the development of early phase clinical research in Malaysia. The idea of having a phase I clinical trial unit started in early 2009. Hospital Ampang was recognised as a perfect hospital to set up an early phase clinical trial unit. What does CVM do? comparing new generic medicine with branded medicine 1. Phase I studies investigating absorption, distribution, metabolism, excretion and plasma level 2. Bioequivalence study 3. Bioavailability study 4. Promoting volunteering for drug study 5. Public education 6. Train MOH staff for early phase clinical study About CVM unit, this collaboration + Transfer of technical know-how and research experience
+ Training ground for highly skilled staff in early phase drug development
+ To entice direct foreign investment
+ To create research opportunities for local investigators
+ To create demand for research supporting services National project - Health Care NKEA 1. Young, age 18 - 45 years old 2. A physical examination with no clinically significant findings 3. Laboratory tests with results all within normal limits such as Hematology, kidney function, liver function, urinalysis, urine microscopy, immunological tests, pregnancy test (if applicable) 4. Chest X-ray clear 5. ECG normal 6. Free of any type of diseases How to minimise and manage risk Informed
consent for
registration Registration Calling for study
specific screening 1 2 5 Enter details into
Volunteer Databank Screening for
eligibility Study specific
Informed
consent
&
Screening 3 4 6 Confirmation of eligibility 7 join a
study The process of recruitment some ethical concerns for
recruiting healthy volunteers Does a healthy person really need the pill?
What about the short term and long term side effects?
Economically vulnerable volunteers
undue inducement Why do we need healthy volunteers?
Disease can modify our bodily function, thus can change the way we interact with drug molecules

for example: Motivation for healthy volunteers I hate to say so......but in reality because of being healthy, they do not need to take medicine.

so, why do they volunteer themselves? Monetary compensation How much is a fair compensation?

How much is considered
as an inducement? Risk and benefits Unnecessary drug exposure

Potential adverse event, etc Extra income that might help to relieve financial burden. Sound study design with proper precaution
Physician must be around when study is going on
Well equipped emergency trolley, equipment and drugs
Trained staff, ACLS, BLS, etc
Contactable research staff, physician at all time, etc. what are the rights
of being a
volunteers? Informed consent 1. Consented and receive full explanation of
study design and objective
potential risk involved
possible side effects
duration
study procedures
reimbursement, etc Protection & coverage Participation must be covered by trial/ unit insurance
Proper medical care in case of any adverse event
Identify must be kept confidential & protected 2. provided a copy of the informed consent document Other rights Self withdrawal must be allowed at any time even though informed consent has been signed
properly compensated for their effort to complete the study
must be informed about new side effects, etc Volunteering for clinical research even though you're healthy What I believe What we're are conducting today will be translated into cheaper / new future medicine that might save million of lives! and I believe Anyone i know and care might be one of the lives being saved in the future! Thank you for your attention! recruitment poster Recruitment drive/booth Social media like
facebook, web page, etc For clinical trial generic medicine vs orginal medicine 2. Bioavailability study investigation of absorption, distribution,
metabolism,excretion, and plasma level 3. Phase I studies 1. Bioequivalence study safer comparing to unhealthy volunteers

easily manageable

less potential drug-drug interaction Sound bodily system and physiological environment that allow the study of complete drug absorption, distribution, metabolism and excretion more stable plasma level for fair comparison A diabetic patient would have a poor kidney function which may reduce the excretion of a drug. This might lead to high plasma level and causes drug toxicity. There is no standard amount, depending on study design, duration and procedures involved, Even we're healthy now, one day we will grow old and suffer from diseases... Risk Benefit Is there a benefit? 1. Direct benefit - nope, I don't think so 2. Indirect benefit - Yes Detection of unexpected illness through medical screening and laboratory tests Advancing medical science and development of new/cheap medicine for future What do you believe?
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