Seven Key Questions to Ask About Clinical Trials

Participating in a clinical trial can benefit an individual in various ways such as giving him or her an opportunityto play an active role in their own healthcare, allowing them to gain access to new research treatments and giving them the knowledge that they are helping others by contributing to medical research. Therefore, it is vital to understand as much as possible about your specific clinical trial. Here are eight key questions to ask before entering a clinical trial.

1. What exactly is a clinical trial?

Clinical trials are carefully designed research studies in which people help doctors find ways to improve their patients’ health and treatment related to specific diseases or medical conditions. Each study attempts to answer scientific questions and to find better ways to prevent, diagnose or treat that condition.

2. Who can participate?

All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" or "eligibility criteria" and those factors that disallow someone from participating are called "exclusion criteria." These criteria are based on factors like age, gender, the type and stage of a disease, previous treatment history and other medical conditions. Before joining a clinical trial, a participant must qualify or be eligible to participate in the study.

3. What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. In this process, the personis informed of every negative and positivefactorof the trial as well any information related to theclinical trial. Informed consent is not a contract and the participant may withdraw from the trial at any time.

4. What is a protocol?

The protocol is a plan that is carefully designed and reviewed by administrators and other researchers to safeguard the health of the trial participants as well as answer specific research questions. The protocol describes the rules and regulationsinvolving the clinical trials such as the types of people that may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study.

5. What are the benefits of participating in a clinical trial?

Participating in clinical trials that are well-designed and well-executed can benefit a participant in various ways, including:

• Playing an active role in their own healthcare.
• Gaining access to new research treatments before they are widely available.
• Obtaining expert medical care at leading healthcare facilities during the trial.
• Helping others by contributing to medical research.

6. What are the risks of participating in a clinical trial?

There are definite risks to some clinical trials such as serious, or possibly life-threatening, side effects.

7. Will my safety and privacy be protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. Therefore, your safety and privacy will be a priority.

Find a Trial Near You

International Research Services, Inc. (IRSI) is committed to providing personalized and professional clinical trial services to cosmetic and pharmaceutical enterprises of any scale. Our attention is always focused on subject safety, regulatory compliance, quality of results and exemplary customer service. IRSI is a leader in biophysical instrumental analysis on the effects of test products on human skin.

To arrange for a visit or for any additional information, please call 914-937-9483 or 914-417-4112 or email info@irsi.org.