Q: What is a clinical trial?
A: Carefully conducted clinical trials are the safest and fastest ways to find potential treatments and new ways to improve health. 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.
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 Food and Drug Administration (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 do not do clinical trials, we cannot 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 studies 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 are my responsibilities as a volunteer?
A: Depending on the type of the study you are volunteering for, there are certain conditions we may ask you to meet to ensure accurate study results. These could include restrictions on exercise, smoking, medications and alcohol. Spaulding Clinical staff will give you full details before you apply to take part in a study so you will always know what is expected.
Q: Can I take part if I am on medication?
A: This varies for each clinical trial depending on what medication you are on and the trial design. Each study has different requirements for volunteers. Most healthy volunteer studies require just that, healthy volunteers, and therefore if you are taking long-term medication, you may not be suitable. Often if you are on short-term treatment, for example, a week of antibiotics for a throat infection, you would be able to take part once you have finished the course of the medication and the condition it was treating has cleared up. However, research is also conducted in patient groups, such as people with Diabetes or High Blood Pressure, who may need to take medication to manage their condition. In this case, it will depend on the study requirements, but the trial will often be designed to allow volunteers to still take their normal medicines. As this changes from study to study, please contact our Recruitment Department to discuss what clinical trials will work for you. In addition, if you are diagnosed with a condition, please notify our Recruitment Department to add this information in your file, so that we could contact you if we have a study looking for that particular condition in the future.
Q: How do I find out if I am eligible?
A: If you are interested in a study and meet the basic guidelines provided, contact our Recruitment Department. Spaulding Clinical Recruitment staff can assist you in determining if a study is a good fit for you by explaining the clinical trial, going over the study length and dates, and asking you several health history questions to see if you qualify to schedule a screening appointment. All of our studies have different eligibility requirements, so if you do not qualify for one study that does not mean that you will not qualify for a different one in the future. If you ever have any questions regarding your eligibility, please contact our Recruitment Department.
Q: How can I find out about upcoming Clinical Trials?
A: If you would like to be put on our email list and get registered in our database, please fill out the short online questionnaire listed under the "Volunteer" tab. You only need to register once for your database and email list. In addition, if you would like to receive text alerts, Text: STUDY To: 36000. When we release a new study, we will send out a text alert, email our database, and update the "Available Studies" page on our website and phone recording. Volunteers are also always welcome to call our Recruitment Department to see if there are any available clinical trials. The Recruitment Department can be reached Monday - Friday from 9:00amCST - 5:00pmCST at 1-800-597-4507. If you are calling outside of business hours, leave a voicemail and our Recruitment Staff will return your call the following business day.
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 clinical trial, you will then be confined at the research campus for anywhere from 1 to 45 days, depending upon the study. Some studies can include Outpatient Visits, which are special separate trips that you need to make to our facility, with the ability of leaving after your visit. The days of these Outpatient Visits are already chosen ahead of time and the length of these visits will depend on the study. It is very important to collect study data at set times, in order to understand how a medicine works. To accomplish this, you will need to attend the Outpatient Visits on the dates/times provided to you during your screening appointment. For more information on the length of the studies that we currently have, please visit the "Available Studies" portion of our website.
Q: What should I expect when coming in for a screening appointment?
A: At your screening appointment, you will be tested onsite to determine you eligibility for the study. Spaulding Clinical staff will review the Informed Consent with you, go over your medical and medication history, perform a physical exam and vital signs, determine your weight, height, and Body Mass Index (BMI), (if female) perform a pregnancy test, screen for drug and alcohol abuse, test your blood and urine, perform an HIV and Hepatitis screen and an ECG procedure. Since each clinical trial is different, there may be additional tests that could be conducted. Generally, your screening appointment will last between 3 - 4 hours, unless specified differently. You will need to bring along a valid and non-expired photo ID, such as a Drivers' License, Passport, or State ID. If you do not have a valid or non-expired photo ID, you will not be allowed to screen. If you have any questions regarding your screening appointment, please contact our Recruitment Department.
Q: What is Informed Consent?
A: The Food and Drug Administration (FDA) requires that potential participants be given complete information about the clinical trial. 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. At Spaulding Clinical, the Informed Consent process is unique in the sense that it starts as a one-on-one time that you have with our staff to ask as many questions as you need to in order to understand the clinical trial. We want to make sure that all of your questions are answered before moving to the next portion of the screening appointment. The Informed Consent process continues throughout your participation, as any questions that you have will be answered at any time.
Q: Will I be compensated?
A: Yes, all of our clinical trials have a monetary compensation. Compensation varies from study to study and is determined by the length of stay and the particular study. Our study list on the "Available Studies" portion of the website 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 clinical trial. Studies may also involve one or several Outpatient Visits. 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 appointment 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 state-of-the-art facility amenities include:
- Located just minutes off of Hwy 45
- Situated in a quiet Residential area
- Free Parking
- Executive Chef on staff
- Wireless Internet
- Free Washer and Dryer
- Top Notch Staff
Our spacious volunteer suites include:
- A "privacy curtain" to create your own space in each room
- Private satellite TVs
- Private bathroom with shower
- Two adjustable Thermostats per room
Our unit also contains a large recreation area with various amenities including:
- Big screen TV with DVD player
- Pool Table
- Video Gaming Systems
- Video Game and DVD Library
- Board Games
- Book Library
- Public Computers
- 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. To find out if you are eligible for a new clinical trial, please contact our Recruitment Department.
Q: What can I bring with me if I check in for the study?
A: You will need to bring your valid and non-expired photo ID, such as a Drivers' License, State ID, or Passport with you to check in. If you do not bring your valid and non-expired photo ID with you, you will not be allowed to check in. A complete list will be shown during the Informed Consent process at your screening appointment of what items you can and cannot bring to check in. You must bring enough clothing for the entire stay. We will provide scrub tops on the dosing days, but you must provide your own bottoms. Please remember to bring shampoo, soap, toothbrush, toothpaste, or any other toiletries needed. You may also bring your personal laptop, mobile phone, books, magazines, movies, etc. Spaulding Clinical is not liable for any lost, stolen, or forgotten items. Please be considerate of what you are bringing along with you to the study. Please leave any valuables at home. If you have any further questions on what is allowed and not allowed on the study floor, please contact the Recruitment Department prior to check in.
Q: What can I not bring with me if I check in for the study?
A: Items that are not allowed include, but are not limited to, the following:
- Weapons, including knives, scissors, and sharp metal objects such as nail filed and nail clippers
- Drugs, including prescription and over the counter medications, vitamins, or herbal supplements, including eye drops, prescription deodorant, or essential oils
- Magazines or movies that contain violence or nudity
- Any food or drink items, including tea bags and water flavorings
- Breath mints and gum
- Anything with Medicated "Active Ingredients", such as acne creams, whitening toothpaste, or dandruff shampoo
- Any medicated topical creams or lotions, including those with added vitamins
- Alcohol or Alcohol containing liquid items, including mouthwash or body spray
- Any other items deemed inappropriate for overnight stays at our facility
We restrict what is allowed in our facility for the safety of all volunteers and the purity of the data that is collected for the clinical trial. If you have any further questions on what is allowed and not allowed on the study floor, please contact our Recruitment Department prior to check in. If you bring along something that is not acceptable on the study floor, we will securely lock it up in our volunteer lockers, will hold it during your stay, and return it back to you before you depart. Spaulding Clinical is not liable for any lost, stolen, or forgotten items. Please be considerate of what you are bringing along with you to the study. Please leave any valuables at home.
Q: How will I be protected and is my information confidential?
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.
Q: Can I have visitors when I stay at Spaulding Clinical?
A: If you are chosen to participate in a clinical trial, you may have visitors as long as they are approved by our staff prior to their arrival. Spaulding Clinical reserves the right to restrict visitors as necessary. Children 12 and under must be accompanied by an adult and supervised at all times. To receive more information on our Visitor Policy, please contact our Recruitment Department.
Q: Do you have a referral program?
A: Yes, we do have a referral program. For the official rules, please visit the "Referral Program" portion of our website.
Following are several additional resources available regarding clinical research participation, legislature and policy:
Provides information on clinical trials, a list of 35,000 industry and government sponsored clinical trials, and a list of new FDA-approved treatments.
Provides regularly updated information about privately and federally supported clinical research in human volunteers.
Provides guidance and notices on good clinical practice and the conduct of clinical trials.
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’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.
A guide to the risks and benefits of volunteering for clinical trials.