What To Expect When Participating In Clinical Trials With PPD

Becoming a part of a research study is a generous act – one that has the potential to help millions of people who can’t find relief from medications that are currently available on the market. When you join a clinical trial, you are helping to evaluate a potential new drug’s effects in the body – how well it works, how it compares to currently available drugs on the market, and other critical factors that determine whether the drug should be approved for use.

Volunteers are generally paid for their time, and they receive study medications and study-related healthcare at no cost.

Every study calls for a different type of volunteer, depending on the condition and the drug being studied. Most Phase 1 studies involve healthy volunteers, and some involve patients who have the disease being studied. Each study will outline the criteria you must meet to be eligible.

Generally speaking, study volunteers must be 18 years or older or have a parent consent if the study is for children.  Depending on the study, you may not be eligible to participate if you use tobacco products, illegal drugs or drink alcohol in excess; are pregnant/breastfeeding; or have certain health conditions that might disqualify you.

Yes. You may withdraw at any time for any reason. You are never obligated to continue, simply because you signed a consent form. The consent form simply acknowledges that you understand the information we provided to you about the trial.

Volunteers for clinical trials receive compensation for their time. The amount varies by study and depends on how long and involved the study requirements are. Each study will list the compensation amount. Additionally, all study medication and study-related healthcare are provided at no charge.

Whether it’s aspirin, alcohol or caffeine, every substance we consume has the potential to cause side effects. Prescription medications are no different. Every study medication has the potential for side effects, but clinical trials are carefully controlled to ensure your safety. 

First, every study drug undergoes extensive laboratory testing as well as use in laboratory animals to assess potential side effects before research studies in humans are allowed.

In addition, all protocols are carefully analyzed by an institutional review board (IRB) composed of members of the public, including medical professionals, who are independent of the clinic and PPD. The IRB reviews and evaluates each study protocol to determine if it complies with international regulatory guidelines to ensure volunteer safety and well-being.

The IRB exists to protect your rights, safety and well-being. The board reviews and approves all aspects of each study, including the type and dose of medicine that will be given to you, all of the measurements that will be conducted throughout the study, and the payment you will receive.

The doses of the medicine that volunteers are given are very carefully controlled, and all volunteers are carefully monitored throughout the study. However, sometimes there may be side effects. All known side effects will be explained to you before you decide to take part in a study. These side effects are generally mild and temporary, going away when you stop taking the study drug. For your own safety, it is essential that you always tell the study coordinators about your pre-existing health conditions as well as prescription and nonprescription medicines (including vitamins and dietary supplements) so they have a full picture of your health before you enroll. 

When you call PPD to inquire about being a clinical study volunteer, a representative will talk with you about your present health and medical history. If you meet the criteria for the clinical study you’ve chosen, PPD will ask you to come to the clinic for a screening and consultation.

Study exam at no cost

To confirm that you meet the study’s requirements, a physical exam will be conducted. The exam may include: measurement of your height, weight temperature and blood pressure; a heart trace (electrocardiogram); an analysis of blood and urine; other diagnostic tests as required by the study protocol. All examinations and tests are free of charge.

Whether you qualify for the study or not, a clinic staff member will contact you after your consultation and confidentially share the results of your physical examination and any screening tests that have been done. The clinic staff will notify you should the results of your screening tests or physical examination warrant additional follow-up examination from a health-care provider.

During the screening and consultation, a medical professional will talk to you about the parameters of the clinical research study, including any known side effects associated with the medicine being studied. The medical professional will also answer any questions you may have about participating in the study. Then, you will be asked to sign an informed consent form stating that you agree to participate.

Informed Consent

During the screening and consultation, a medical professional will talk to you about the parameters of the clinical research study, including any known side effects associated with the medicine being studied. The medical professional will also answer any questions you may have about participating in the study. Then, you will be asked to sign an informed consent form stating that you agree to participate.

Completely Confidential

All information that you provide to the clinic – and all medical records — are kept confidential, as required by law.

If you qualify as a volunteer, you will be contacted to schedule your participation in the study. As with any clinical research study, you are free to withdraw your participation at any time.

Every study medication has the potential for side effects, just like every approved drug on the market has the potential for side effects. To ensure your safety, every study drug undergoes extensive laboratory testing as well as use in laboratory animals to assess potential side effects. 

Second, every study is overseen by a team of medical professionals, including one or more physicians, whose job is to ensure your safety and comfort.

Third, all protocols are carefully analyzed by an institutional review board (IRB) composed of members of the public, including medical professionals, who are independent of the clinic and PPD. The IRB reviews and evaluates each study protocol to determine if it complies with international regulatory guidelines to ensure volunteer safety and well-being.

The IRB exists to protect your rights, safety and well-being. The board reviews and approves all aspects of each study, including the type and dose of medicine that will be given to you, all of the measurements that will be conducted throughout the study and the payment you will receive. 

The doses of the medicine that volunteers are given are very carefully controlled, and all volunteers are carefully monitored throughout the study. However, sometimes there may be side effects. All known side effects will be explained to you before you decide to take part in a study. These side effects are generally mild and temporary, going away when you stop taking the study drug. For your own safety, it is essential that you always tell us about your pre-existing health conditions as well as prescription and nonprescription medicines (including vitamins and dietary supplements) so that we have a full picture of your health before you enroll.

The timeline for studies varies considerably. Studies can involve a single visit to a clinic, a weekend or two in a clinical research unit, or periodic (monthly or quarterly) visits to the clinic for several months or years. Post-study follow-up visits (called “outpatient visits”) for blood samples are sometimes necessary.

The study coordinator will tell you in advance what to bring. For overnight stays, you’ll need to bring all toiletries and personal items for the duration of your stay. Do not bring in any food, drink or cigarettes if it is a non-smoking study. 

Yes, volunteers can bring their cell phones with them when participating in a study. However, if the cell phone has a camera, it must either be removed or covered with tamper-proof tape provided by PPD. No cameras of any kind are allowed in the clinic. Cell phones also must be turned off during study procedures.

Yes, qualified medical staff are always available, and a doctor is on call at all times. The health and well-being of every volunteer is our top priority. 

An HIV test is required for some studies. You will be informed during the screening process as to whether you will need to be tested for HIV.

To sign up for a study, call PPD at (877) 773-3707. On the call, a representative will ask you questions about your present health and medical history, and will schedule an in-person screening appointment if you qualify for the study you have selected. 

During your screening visit, we may do tests that are not normally conducted during a routine medical checkup. For example, tests may include a heart trace (electrocardiogram) or blood tests. If the results indicate a potential issue, we will repeat the test to verify the results. If we detect a potential health concern, our staff will refer you back to your primary care doctor, with a copy of your lab results, for further evaluation.