More About Clinical Trials
Clinical Research FAQs
What Happens After a Clinical Trial?
The end of the clinical trial does not mark the end of all communication between you and the research team. Once treatment is complete- and the study is closed- participants should feel free to ask the trial staff what treatment they received. The study staff shares this information as soon as it is available (if they are allowed to do so). They will also share the clinical trial results when they become available.
How Long Can a Clinical Trial Last?
The length of a clinical trial depends on several factors, such as the type of illness and medication/device being researched. For example, if the study is conducting research on a treatment for a chronic condition, the participant will be observed for a relatively long period. However, a clinical study for an antibiotic may quickly conclude because participants complete treatment within a couple of days.
Reimbursable & Compensation Costs
Participants can be reimbursed for:
- Travel expenses
- Loss of income
What kind of compensation can participants receive?
Compensation for participation in a clinical trial can take many forms. It may include:
- Monetary benefits
- Payment and other additional benefits, if anything.
- Payments and reimbursement to make up for any inconveniences.
Compensation is most common in Phase I trials with healthy volunteers. It is given to participants as recognition of their time and as an appreciation for their contribution to science.
What Are the Costs of Participating in a Clinical Trial?
In some cases, participation in a trial will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for the drugs, devices, and services they provide. It is possible that your insurance company may not pay for some or all of the charges- and you may receive a bill for those costs. The informed consent form will describe any costs to you in detail. If the information in the consent form is unclear, you can ask the research team to explain/clarify any potential out-of-pocket costs before you sign the consent form.
Are Any Lifestyle Changes or Restrictions Required?
Any changes or restrictions to your lifestyle during a clinical study depend on the protocol and treatment in question. In some cases, some clinical trials may have more limitations than others.
How Many Visits Are Required?
A standard trial proceeds forward in several phases:
- A screening Visit: The investigational staff reviews the informed consent document and goes over your medical history.
- Baseline Visit: This visit may happen simultaneously with the screening visit. Here, you will receive the study medication/treatment/device. The investigational staff will also review the dosing with you.
- Routine Study Visits: These are periodic visits done throughout the study to track an individual’s progress during a clinical trial. At the visit, the study team may have to:
- Acquire Bloodwork
- Administer study treatment
- Perform a physical exam
Source: Uva Health
What Information and Medical Tests Are Required?
Depending on each clinical trial, requirements for that visit will change because each study will have a different set of criteria. Some studies may require various tests- others may have little to none. During the screening visits, the investigational staff will give participants an overview of the clinical trial and ask questions to see if they meet the study's requirements (outlined in the study protocol). The general tests and information required include:
- Routine physical examination
- Review of medical history
Source: Uva Health
Benefits & Potentials Risks of Clinical Trials
Benefits of Clinical Trials
- You may get a new treatment for a disease before it is available to the public.
- It enables you to have a more active role in your health care.
- Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
- You have the opportunity to help others get better treatment for their health problems in the future.
- You may be able to get information about support groups and other resources.
Potential Downsides of Clinical Trials
- The new treatment could have potential side effects.
- The treatment may not work as intended or may not be as effective as treatments that are currently available.
- Participating in a clinical trial is a time commitment. You may be expected to stay overnight or for several days over the course of a trial.
Are Clinical Trials Safe?
The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial. The Federal government has regulations and guidelines for the management of clinical research to protect participants from unreasonable risks. They require researchers to give prospective participants complete and accurate information on the precise nature of each step of a trial. Therefore, before joining a study, participants are given an informed consent document that outlines their rights as a participant. They are also provided with, details on the nature of the study, including any potential risks.
What Risks Should I Consider Before Joining a Clinical Trial?
Before joining a clinical trial, it is recommended that you do as much research on the study as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. Also, discuss the Clinical trial with your health care provider to determine whether the study is a good/possible option based on your current treatment.
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