faqs
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Frequently asked questions about clinical trials

Why is medical research so important?

Thanks to the efforts and skills of many generations of researchers, we can currently cure or control many diseases that would formerly have proved fatal, such as smallpox and malaria. However, without the commitment of patients who volunteer themselves for controlled clinical trials, we would not know how effective these potential new treatments can be or decide which patients might benefit most.

Medical research is essential to investigate the safety and effectiveness on an investigational drug before it can be approved by the FDA or other regulatory health authorities. It helps in the continual development of treatments that may be safer and/or more effective than the drugs before them.

What is a clinical trial?

A clinical trial is a carefully designed (planned) study involving participants who receive investigational treatment under the supervision of a physician and other research professionals. The investigational treatment will already have been assessed by scientists and in carefully controlled experiments involving animals to ensure that there are no obvious safety issues before it is given to humans.

Clinical trials are divided into different phases, denoting the kind and number of participants involved:

Phase I trials are the first time that the treatment is given to humans, and participants are usually healthy volunteers who help to provide data on the safety of the treatment.

In Phase II trials, the treatment is given to a small and carefully selected group of patients with the disease that the treatment is intended for. At this stage researchers are still looking at the safety of the treatment and are also trying to find out the optimum treatment strategy (e.g. the dosing and duration of treatment).

Most people taking part in clinical trials are usually involved at Phase III, where the treatment is given to larger numbers of patients, and its efficacy and safety are compared with existing treatments or placebo (with no active ingredient) treatments.

What rules are in place to protect my safety in medical research?

Clinical trials must follow rules set by the U.S. Food and Drug Administration (FDA) or other regulatory health authorities, and each study must be approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). An IRB or IEC is a group of people who are responsible for helping to protect the rights and welfare of research study participants. IRBs or IECs are usually made up of doctors, scientists, religious representatives, and other medical and non-medical people.

Before the investigational treatment reaches clinical trials involving humans, it will already have been assessed by scientists and in carefully controlled experiments involving animals to ensure that there are no obvious safety issues before it is given to humans.

Therefore, although experience with the investigational treatment is limited and new information about its safety is still being collected, you can be reassured that everything is being done to prevent you from coming to undue harm if you take part in medical research.

What are the risks of taking part in medical research?

Placebo

In some studies, all participants receive the active investigational medication or study drug. In other studies, some participants receive the active investigational medication, while other participants receive a placebo. A placebo looks like the study medication, but has no active ingredient. There is, therefore, a risk that you may not receive any active treatment for your symptoms if you take part in a clinical trial. Nonetheless, whether you receive the active medication or placebo, you will be given the same overall healthcare, and your physician will ensure that you are not being unnecessarily deprived of treatment that you need.

Side effects

Some investigational treatments can have unpredictable side effects, which may be unpleasant or affect your health. The study physician or research staff will discuss possible side effects of medications used in a study with you. You should always raise any concerns you may have with your site study team.

What happens to my treatment and care after the study?

After a clinical trial is complete, all of the information is collected and analyzed to help determine the study treatment's efficacy and safety. If the data indicate that the treatment is of benefit, an application will be made to the FDA and other healthcare regulatory authorities to evaluate if the treatment is safe and effective to be licensed for general use. This process can take some time.

In the meantime, many Phase III clinical trials include an extension phase during which all participants are offered the chance to continue taking the investigational treatment, so that long-term data can be collected on its safety and ongoing efficacy. The study physician or your family doctor will be able to advise you on whether you can continue to take the study treatment and what other options are available for you.

Can I change my mind about participating in a trial once I have started?

As a participant in medical research, you are always free to stop at any point. However, it is usually a good idea to go to your study physician for one final check-up, because your body can continue to react to a treatment for some time after you have stopped taking the treatment.

The protocol for the Dignity study has undergone the appropriate review by regulatory authorities and ethics committees.