Following are the ten major considerations (questions to ask) before participating in a Clinical Trial. It is a Patient’s Perspective of What You Need to Know.
1) Where do the ideas for clinical trials come from?
The ideas for clinical trials are proposed by researchers. Every new drug research is at first tested with many procedures in the laboratory and in animal studies. The experimental treatments with the most promising laboratory results (in vitro and animals) are moved into clinical trials. In clinical trials more information is gathered on experimental treatment, its risks and how well it may or may not work.
2) Why participate in a clinical trial?
By enrolling themselves participants in clinical trials can play a vital role in their own health care, can gain access to new research treatments before being widely available, and help contribute towards betterment of society and to medical research as a whole.
3) Is it safer than regular treatment?
The scientific and ethical conduct followed in medical practice also applies to clinical trials. Going a step ahead, most clinical research is well regulated with built in safeguards to protect the rights, safety and well-being of participants. Individual participants’ names remain secret and are not be mentioned in any reports.
4) Informed Consent- Everything should be informed beforehand:
As per ICH – GCP informed consent is “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.”
There are translations in native language provided in case required. Informed consent document includes details about the study, such as its purpose, duration, required procedures, and key contacts along with risks and potential benefits. As informed consent is not a contract, the participant may withdraw from the trial at any time.
5) Questions to asked before enrolling in a clinical trial:
The following questions might be helpful for the participant to discuss before participating in a clinical trial:
Answers to most of these questions can found in the informed consent document.
– What is the purpose of the study?
– Who is going to be in the study?
– Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
– What kinds of tests and experimental treatments are involved?
– How do the possible risks, side effects, and benefits in the study compare with my current treatment?
– How might this trial affect my daily life?
– How long will the trial last?
– Will hospitalization be required?
– Who will pay for the experimental treatment?
– Will I be reimbursed for other expenses?
– What type of long-term follow up care is part of this study?
– How will I know that the experimental treatment is working? Will results of the trials be provided to me?
– Who will be in charge of my care?
6) My liability in case if any reaction or safety problem?
Any expenses related to any side effect/undesired effect/reactions/serious adverse event (SAE) must be taken care of by the sponsor or must be covered by insurance which will be the responsibility of the sponsor.
7) Who is in charge and who take care of rules?
There is continuous monitoring of clinical trials by the sponsor or the organization responsible. Also applicable regulators keep their eye on conduct of clinical studies. After completion of the clinical trial all the data has to be submitted to regulatory authorities to finally approve and market the drug. Every clinical trial site/hospital is also monitored via ethics committees who check the study on a regular basis for ethical and scientific conduct.
8.) Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant may be asked by the research team the reason to quit, but answering this is not mandatory.
9) What happens after your role is over?
After completion of any trial the development of the new drug either moves towards the next phase (Clinical trials are conducted in 4 phases) or the data is submitted to regulatory authorities for marketing approval to bring the drug to market. The study may get published with results.
10) What is “expanded access”?
By definition, “Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.”
Not every patient will be willing to participate in a clinical trial of an investigational drug, but he/she may have a serious disease or condition that may get benefited from treatment with the investigational drug. FDA regulations enable manufacturers to provide those patients access to the drug under certain situations, known as “expanded access.” The manufacturer must be willing to make the drug available for expanded access use. As per regulators and ethics, the primary intention of expanded access is to provide treatment for a patient’s disease or condition, rather than to collect data about the study drug.
Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov
1. ICH – International Conference on Harmonisation Good Clinical Practices, Jan 30th 2012, http://ichgcp.net/2-the-principles-of-ich-gcp-2
2. Clinical Trial Registry by USA regulator, Jan 30th 2012, http://www.clinicaltrials.gov/ct2/info/resources.