All clinical trials have guidelines about who can participate. Participants are involved as ‘healthy volunteers’ or ‘patient volunteers”.
The four New Zealand Health and Disability Ethics Committees are responsible for the ethical oversight of studies. (http://ethics.health.govt.nz/)
Patient volunteers are usually referred or recommended through their medical specialist or general practitioner.
Healthy volunteers largely participate in generic bioequivalence studies. In these studies a new manufacturer must demonstrate for the purposes of regulatory authorities that their product (tablet, capsule cream, etc) provides a similar blood profile to the market leader. The new “generic” drug is cheaper than the original patented version, because of much reduced research and development costs. Many people around the world will have used the market leader and thus the effects and side effects of these drugs are well known and predictable, and this information is part of the informed consent process. Furthermore, multiple doses of a medication will have been taken for a treatment period, in contrast to bioequivalence studies that require two or three doses with no body accumulation of medication between doses.
Some of the standard guidelines for healthy volunteers in generic bioequivalence studies are as follows:
- Testing for drugs of abuse such as cannabinoids (Marijuana), amphetamines, benzodiazepines and opiates (ie morphine, heroin, and codeine) is usually performed as part of the screening process. Alcohol breath testing is routine at the commencement of each part of a study.
- You may be required to fast from the night before a study starts until the next lunchtime. On the other hand some studies require a substantial breakfast to assess the influence of the stomach on absorption of a drug.
- You are usually required to stay at the Zentech Clinical Site for about 24 to 48 hours, sleeping over without the opportunity for visitors or leave.
- Food restrictions may apply, and while at the Zentech Clinical Site we provide all meals and beverages.
- Before beginning a study a screening process will ensure your understanding of the processes involved and that your health is appropriate for inclusion in a study. This routinely involves a medical examination by either a male or female medical practitioner. At your medical examination, a family or whanau member, a friend or chaperone may be present with you in the examination room if you wish.
- Diagnostic blood samples will be taken before and after the study to enable an assessment to be made of your organ functions, and includes tests for Hepatitis B and C and HIV. Please note strenuous exercise, exercise supplements, alcohol intake, and poor diet all affect the results, and may necessitate repeat samples or study exclusion.
- Females will be required to undergo a blood pregnancy test before, during and after the study, and are encouraged to continue prescribed hormonal contraceptives.
- Your participation is voluntary and you are free to withdraw from a study at any time
- A study timetable is provided that details study events.
- Although there is some variation in the screening processes (depending on the study), general guidelines are as follows:
- The age range is 18-55 years inclusive (for most healthy volunteer studies)
- For healthy volunteer studies any history of recurring or undiagnosed health problems, prescribed or over the counter medications that could interfere with the study drug in the last 7 days or within 14 days prior to dosing, or history of alcohol/drug abuse or dependency (or test positive for drug use as part of the screening procedures) will usually result in exclusion.
- Planning to start a family within 60 days of taking a study drug, pregnant or breastfeeding are exclusions.
- We will only include potential participants who understand the consent information or screening processes and provide written consent.
- Participants must consent to their GP being contacted prior to the commencement of the study (if necessary, about their medical history) or during the study to report any adverse reactions.
A meeting will be held with all potential participants to explain the study requirements and procedures. You are strongly encouraged to ask questions at this meeting and in private afterwards. You are also encouraged to ask questions during screening and in particular during the privacy of a meeting with the medical practitioner. You may withdraw your consent at any time.
If you haven't registered yet this year please register here. We will contact you with our new study details after the study has been scheduled.