Potential Risks and Benefits

If you are considering taking part in a clinical trial, it is important to weigh all the potential risks with the benefits to decide if volunteering is the right decision for you. It is encouraged that you consult your healthcare provider to discuss your possible participation in any clinical study. All details regarding the trial, process, anticipated risks and benefits will be provided to you by the coordinators of the study to ensure that you know what to expect before giving your consent. Prospective participants are encouraged to make a decision that they feel comfortable with.

Benefits

Early access to promising new research treatments that are not yet publicly available. These new treatments may have less side effects or be more effective than what is currently offered to the general population, with the possibility of successfully remediating or controlling your condition. Outside of the clinical trial setting, it may take months or years before these treatments are approved to go to market.

Become more active in your own healthcare. Electing to participate in a clinical study is a decision you make for yourself regarding your treatment. This provides many with a sense of control and positivity regarding their situation, and can lead to an improved state of being. Through your participation, you may also gain a greater understanding of your disease.

Close monitoring and care by a research team of leading physicians and medical professionals. Your health and progress will be carefully tracked during the duration of the study by a research team with extensive understanding of your disease, who can offer you support and advice. You will receive more frequent checkups and tests than with standard care.

Contribute to medical research and scientific knowledge. Your participation will help countless others even if the trial does not benefit you directly. Volunteers are critical to the success of any clinical study – the information garnered from these studies can be used to develop and advance future treatments.

You may receive compensation for your participation. This depends on the trial in which you participate and will be discussed with you along with other details regarding the study before you provide your informed consent.

Risks.

Clinical trials make every effort to protect the rights and welfare of their participants, and are approved and monitored by independent regulatory bodies to certify that they meet ethical standards. Nevertheless, there will always be some risk to you as a participant.

The new treatment may not work as well as you had hoped. It may be less effective than non-clinical trial treatments already available or have more severe side effects. In some instances, a treatment might show positive results in only some of the participants. It is impossible to guarantee any specific outcome ahead of time.

Side effects that can range from unpleasant to serious or life-threatening. In Phase I and II trials, these effects may not be fully known to researchers yet. Phase III trials are less likely to have severe side effects as more is known about the treatment at this point.

A clinical trial treatment may entail more frequent testing and visits to the doctor. You need to take into consideration the amount of time and money involved with becoming a participant. This includes the cost of regular travel, as well as the cost – if any – of the clinical trial treatment itself. Confirm your coverage with your insurance company prior to consenting to become a participant. While some clinical trials may cover your expenses, not all do. You will be given these details ahead of time by the coordinators of the clinical trial.

 

Your physical and mental well-being is the highest priority and any decision regarding your participation will be respected. Should you at any point wish to discontinue with a clinical trial, you are free to withdraw – you do not need to provide a reason. There are no repercussions to withdrawing from a study.