FAQs Common questions to uncommon problems.
What Are Clinical Trials?
Clinical trials are specifically designed to test the effects of up and coming pharmaceutical products. Clinical trials rely upon volunteers to participate under the supervision of a study physician and other research staff members selected by the pharmaceutical company. The purpose of a clinical trial is to evaluate investigational drugs for safety, tolerability and effectiveness. All clinical trials must be approved by an Institutional Review Board (IRB) before the trials commence. This process helps ensure those patients rights as participants are protected.
What Can Volunteers Expect?
Volunteers in a clinical trial are randomly assigned to a specific study group which may be one of the following:
- A group receiving an investigational medication;
- A group receiving a placebo (sugar pill); or
- A group receiving a comparator medication already available on the market.
In most studies, neither the research team nor volunteer knows which product was assigned to each group. This ensures that the research teams remain unbiased when assessing the volunteers results. All volunteers will be treated equally, no matter what assignment the group has received.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What are the benefits of participating in a clinical trial?
Clinical trials are the best approach for participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Help others by contributing to medical research.
- Have an alternative means for care they otherwise might not have access to.
What should people consider before participating in a clinal trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions, the care expected while in a trial, and the cost of the trial. The following are a few questions to consider asking.
- What is the purpose of the study?
- Why do researchers believe the new treatment being tested may be effective?
- Has it been tested before?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will be in charge of my care?
What are the phases of a clinical trial?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
- Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
- Phase 2: Studies that gather preliminary data on effectiveness. For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
- Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
- Phase 4: Studies occurring after FDA has approved a drug for marketing. These including post market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug’s safety, efficacy, or optimal use.
Inpatient Guidelines Patient Guidelines for Inpatient TrialsIt is our pleasure to welcome you to one of our inpatient sites. We are pleased to have you participate in one of our Clinical Research trials. We have taken the time to prepare for you a list of items to consider to ensure that your stay with us is as efficient, comfortable and as pleasant as possible. Please bring with you the following to your first appointment:
- Copies of your medical records.
- A complete list of all the medications you are taking, and how you take them. You may bring the actual medicine bottles, If that is easier.
- Reading glasses, if necessary.
Please make sure to limit the amount of items that you bring with you for your inpatient stay at one of our sites.
Do Bring the Following for Your Stay:
- 5 daytime outfits
- Pajamas and/or bathrobe (belts are not allowed)
- Toiletries and/or cosmetics
- Hairbrush and/or comb, toothbrush (not electronic)
- Shoes without laces
- Reading materials
- Personal hygiene items will be provided to you.
- Personal ID if you have one if not please ask staff to provide you with one.
Do NOT bring the following items for Your Stay:
- Metal/glass Items
- Shoes with laces
- Plastic bags
- Erotica or pornography
- Valuables (Watches, money, jewelry, & credit cards)
- Any items containing alcohol (cologne, mouthwash, etc)
- Any sharp objects (knives, nail file, scissors, and tweezers)
- Wire hangers
- Hair dryers
- Bleaching items
- Flammable liquids
- Any aerosols
- Sexually inappropriate materials or clothing
- Electronic equipment (i.e. cd player, computers, tvs, fans, etc)
- Cell phone
Thank you for considering participation in one of our inpatient studies.
The Segal Trials Team
Outpatient Guidelines Patient Guidelines for Outpatient TrialsIt is our pleasure to welcome you to one of our outpatient sites. We are pleased to have you participate in one of our Clinical Research trials. We have taken the time to prepare for you a list of items to consider to assure that your experience with us is as efficient, comfortable, and as pleasant as possible.
Please bring the following with you to your first appointment:
- Copies of your medical records.
- A complete list of all the medications you are taking, and how you take them. You may bring the actual bottles, if that is easier.
- Reading glasses, if necessary.
Thank you for considering participation in one of our outpatient studies.
The Segal Trials Team
Any time that there is any information exchanged between a patient and this website, whether that information is channeled through questionnaires or forms on this site or via regular E-mail, will be monitored Internet security measures, i.e. firewalls, in order to preserve high standards of patient confidentiality.
The information posted on this website is not intended to interfere with those relationships between patient and his or her personal physician. Information concerning diagnosis, condition, treatment, or evaluation is meant solely for educational purposes.
2. Accumulation of Evidence
Segal Trials for Clinical Research accumulates patients personal information, i.e. name, address, phone number, or E-mail address, only when this evidence has been voluntarily supplied. If a visitor wishes to keep his/her information private, or if he/she has concerns about maintaining the confidentiality of specific pieces of information within our system, then it is suggested that the visit refrain from providing this information. The information provided to us will only be used for purposes indicated in the type of form that the visitor fills out and/or questions that the visitor answers.
Use of Information
Segal Trials limits access to information only to those individuals who are responsible for responding to visitors specific requests. Segal Trials is required to reasonably safeguard protected health information (PHI) – including oral information – from any intentional or unintentional use or disclosure that is in violation of the Privacy rule. Segal Trials will attempt to contact visitors who have voluntarily submitted their information to the website’s database using the preferred method of contact that has been selected.
The information that is typically requested within the questionnaire is the city, state, and zip code of any visitor who requests information about participating in a Segal Trials clinical trial. Segal Trials requests this information in order to match visitors up with a clinical research site that is within the area. This information is also stored in our database in case there any future studies arise for which those visitors may be qualified. Segal Trials will be able to contact visitors in the future should this situation occur.
This website is meant to act as a setting for collected information for those purposes specified by visitors. Segal Trials has no control over the quality, truth, or accuracy of information supplied by visitors; it is not the responsibility of Segal Trials to determine the validity of the submitted evidence. Visitors to the website are personally responsible for the information that they voluntarily submit to Segal Trials.
Only the visitor may provide us with the authorization to use the information supplied for the purposes for which it was provided. Segal Trials is under no obligation to use or retain any of the information a visitor submits, and may choose to delete such information. The visitor must specify if he or she wants that information to be stored within our database for a certain period of time. If circumstances suggest reasons for severing ties with a certain patient, Segal Trials also has the right to suspend or terminate a visitor’s right to submit information to the website.
If visitors have submitted a contact form or prescreen form, and wish it to be deleted from or saved within this database, please email [email protected] If possible please specify what contact form was filled out and when it was submitted so the proper information can be removed from the appropriate database.
Patients may also send their inquiries regarding clinical trials [email protected]