Clinical trials are essential to the pharmaceutical industry since New Drug Applications (NDAs) have to be tested and their safety and efficacy proved before they can be availed to the public. Clinical trials happen at the end of a long research and development process that started at the laboratory, followed by animal studies, and finally concluded with human trials. By the time an NDA is being put to human trials it has already overcome major hurdles and is only a step away from formal approval. Clinical trials are however fraught with lots of ethical issues that drug companies and clinical trial services cannot simply wish away. Virtually every stage of a clinical trial can raise ethical questions but it is recruitment that always seems to attract more scrutiny.
Clinical trials begin with recruitment. Companies often have difficulty recruiting patients so they often delegate this task to clinical trial services. Recruiting patients for a clinical trial is no easy task even for medical trial services. In their bid to meet recruitment targets trial services professionals often do things that bring about ethical questions.
When recruiters are asked to bring on board a certain minimum number of patients and they are having trouble reaching the target they are likely to resort to patient recruitment methods that are not very ethical to make patients sign up. Take manipulation and persuasion, for example. Is it really possible to draw a line between persuasion and manipulation in recruitment? Recruiters are nevertheless known to pile pressure on patients and use subtle threats to obtain their consent. Think of a doctor, for example, who tells patients that unless they volunteer for a trial they'll no longer receive care from the clinic. Recruiters are also known to overplay the benefits of an NDA to convince patients to volunteer for a trial. It is definitely unethical to overplay the benefits of treatment that is still under clinical trial to make patients volunteer especially if the patients are chronically ill and desperate for relief.
Patient recruitment services have also been accused for using undue inducements to influence patients. A recruiter puts patients under undue influence if he/she makes them an offer that's too good to refuse. For instance, recruiters can offer free treatment to the patient's family for the entire duration of the trial. Incentives are not wrong unless they have the potential to cloud patients' judgment. You don't expect a patient to decline an offer of free treatment to his/her entire family especially if they are too poor to afford quality medical care on their own. Undue inducements are unethical because patients are likely to overlook the potential risks involved in the study.
Questions have also arisen over the payments given to trial participants. It's common for clinical trial services to offer monetary incentives to patients so that they can take part in clinical trials. Some people believe it's OK to compensate participants for their troubles but other people see it as bribery. The question of payment becomes even trickier if the trial poses significant risks to participants.
It's important for recruiters to be alive to ethical questions that might arise during recruitment and eventually during the trial itself; if a trial is mired in so many ethical problems it may need to be abandoned and started afresh.
Ethical issues that often arise during patient recruitment