Question8: How would you recruit volunteers for phase I of a clinical trial? What strategies in recruiting of volunteers do you think would be considered as unethical or illegal? We will talk about these issues later, but we would like you to figure out first on your own, what should or should not be done in the recruiting of volunteers.
Please, share your opinion
Clinical Trials require the use of human test subjects and can severely impact the well-being of the subjects, as well as treatments of other people and large amounts of capital for those performing the trial, therefore proper management of Clinical Trial is crucial.
Different Strategies of recruiting volunteers for Phase 1 trials are as follows:
1) Word of mouth
2) Advertisement in the press and local radio
3) Increasingly internet is used to attract large number of healthy volunteers.
The strategies which I personally think should be considered as unethical and illegal in recruiting volunteers are:
1) Not providing enough information to the patient about the clinical trial and about the investigational drug.
2) Using money as a motivating factor in recruiting volunteers. We don’t have to make it so attractive that people give up doing anything else and spend all their time doing trials.
3) Increasing people expectations about the effectiveness of a new drug.
4) Checks are made to ensure that healthy volunteers are not taking part in trials continuously. The volunteer’s general practitioner is contacted and a volunteer’s details are entered into a database so that a trial unit can tell if the person has taken part in a trial previously.
Safeguards for volunteers and patients
Trial units are required to comply with guidelines on good clinical practice, good laboratory practice and good manufacturing practice. There are endless audits to ensure that everything is being done to maintain the subject’s safety and data integrity. Pharmaceutical companies are also required to carry indemnity policies so that patients and volunteers can be compensated for injuries incurred during a clinical trial. Volunteers need to be properly informed and educated.