Frequently Asked Questions

Q: What is a clinical trial?

A: Medical research studies involving human volunteers that follow a pre-defined protocol are called clinical trials. Clinical trials are conducted to efficiently allow the safest possible collection of data for investigational drugs or devices. Carefully conducted clinical trials are the safest and fastest ways to find potential treatments and new ways to improve health.

Q: What are the different phases of drug development?

A: It can take between 10-15 years and up to $800 million to develop a new drug. However, this costly and time-consuming process ensures that drugs brought to market are both safe and effective. Spaulding Clinical currently conducts Phase I trials. The clinical testing of experimental drugs is typically conducted within the four phases as outlined below. Each successive phase involves a larger number of subjects. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies.

Q: Are there benefits to participating in a clinical research study?

A: Simply put, if we don’t do clinical trials, we can’t develop new treatments. At Spaulding Clinical, we truly value our volunteer participation, as they are a crucial part of promoting our mission. By volunteering for a clinical trial you can:

• Help evaluate possible new medical treatments and scientific knowledge
• Gain personal satisfaction, knowing that your participation may improve the quality of life for those suffering from chronic disease or illness
• Receive monetary compensation for your participation.

Q: Are there risks to participating in a clinical research study?

A: In every research study, there are potential risks, and volunteers may experience side effects from the investigational drug. As a volunteer, you will be given an informed consent form, which lists possible risks and side effects which you may experience during a particular study. Every potential volunteer must sign and understand the informed consent before enrolling in a study. During every study, volunteers are monitored by a well-trained staff to minimize risk. You have the right to refuse treatment during a clinical trial and may leave at any time and for any reason.

Q: Who can participate in clinical trials?

A: Eligibility requirements are unique to the particular study and usually include criteria for age, sex, health history and basic lifestyle. Some trials involve people with a particular illness or disease, while others seek healthy volunteers. The FDA seeks to ensure that people from many different groups are included in clinical trials.

Q: What should I expect when enrolling in a study?

A: You will be completely informed about the requirements and expectations related to a specific study, including any known benefits or risks of study participation through an informed discussion with one of Spaulding’s medical staff consisting of physicians (MD's), registered nurses and clinical research professionals. Each study is very different, but they all have a screening visit at which time your eligibility will be assessed through interviews, blood draws, physical examinations etc. If you are chosen to participate in the study, you will then be confined at the research campus for anywhere from 1 to 45 days, depending upon the study.

Q: What is Informed Consent?

A: The Food and Drug Adminstration (FDA) requires that potential participants be given complete information about the study. This process is known as “informed consent” and must be given to the potential participant in writing. Our staff will inform you of any known risks, potential side effects, and potential benefits related to your participation before you begin a study. The Informed Consent process gives you an opportunity to ask any questions and discover what is required of you as a volunteer.

Q: Will I be compensated?

A: Compensation varies from study to study and is determined by the length of stay and the particular study. Our study list will provide you with specific information on each study, including compensation

Q: What kind of time commitment is involved?

A: All studies vary in structure and length but will usually include a minimum of one overnight stay. Length of stay may involve several days to several weeks, depending on the particular study. You may choose a study that has a time commitment that is most convenient to you.

Q: Can I change my mind?

A: Since your participation is completely voluntary, you may change your mind at any time during the study if you choose not to participate. You will be provided with detailed information on the particular study at your screening visit to ensure an informed decision.

Q: What is Spaulding Clinical like?

A: At Spaulding Clinical, we hold ourselves to the highest standards. We pride ourselves on providing the best care for our volunteers and ensuring that your stay is both comfortable and safe. Below is a list of amenities available during your stay.

Our spacious volunteer suites include:

• Two beds per room
• Private satellite TVs
• Wireless internet for your laptop
• Private bathroom with shower

Our unit also contains a large recreation area with various amenities including:

• Big screen TV with DVD player
• Pool Table
• Wireless Internet
• Video Games
• Board Games
• Books
• Foosball
• Public Computers with Internet
• Private Reading Room

Q: How often can I participate?

A: Generally speaking, upon completion of a study, you may participate in a new one in as little as 30 days. Some protocols may require a rest period of 60 or 90-days, depending on the sponsor’s specific requirements.

Q: How will I be protected?

A: Clinical trial studies are designed to ensure that volunteers are not put at undue risk. Before testing can begin, the study and all study related materials are carefully reviewed by a committee of experts and community representatives called an Institutional Review Board (IRB). As a volunteer, you have the right to refuse treatment at any point in the clinical trial and leave at any time and for any reason. All clinical trials at Spaulding Clinical are done in accordance to Good Clinical Practices and Federal Regulations. Spaulding Clinical is required by law to keep all volunteer records confidential. Only employees of the FDA or other government authorities, the sponsoring company or their representatives, Spaulding Clinical, or the IRB may review volunteer records and information collected during the study.

Additional Resources

Following are several additional resources available regarding clinical research participation, legislature and policy:

CenterWatch.com
Provides information on clinical trials, a list of 35,000 industry and government sponsored clinical trials, and a list of new FDA-approved treatments.

ClinicalTrials.gov
Provides regularly updated information about privately and federally supported clinical research in human volunteers.

FDA.gov
Provides guidance and notices on good clinical practice and the conduct of clinical trials.

NIH.gov
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary federal agency for conducting and supporting medical research.

Phrma.org
PhRMA’s mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical/biotechnology research companies.

The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research, developed by the Department of Health, Education, and Welfare.

The Declaration of Helsinki
Seminal document adopted by the World Medical Association concerning Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects.

Informed Consent
A guide to the risks and benefits of volunteering for clinical trials.