FAQ

Clinical studies are generally carried out in a hospital or a medical research center. They involve healthy volunteers or patients. Participants are not generally required to stay at the hospital or center throughout the trial, but the effects of the drug will be closely monitored by highly qualified personnel.

Control groups
Clinical studies often involve some sort of comparison with the new drug being tested. This means that while one group of volunteers or patients will be given the product under investigation, another group (the ‘control group’) is given either another treatment or a placebo (a study drug with no active ingredients).

Thousands of patients and healthy volunteers participate in UCB’s clinical research studies. This is essential to the development of new medicines. Every clinical study has its own guidelines on who can take part. These guidelines explain the ‘inclusion criteria’ and ‘exclusion criteria’ for participation.
The inclusion criteria are a list of factors or characteristics that participants must have. For example, researchers may need participants to be of a certain age or to have a specific medical condition.
The exclusion criteria are factors that prevent someone from taking part in a study. For example, certain age groups or people with specific medical conditions may be excluded.

Before taking part in a clinical research study, you may want to discuss it with people close to you. For example, your doctor may offer medical advice; and your family and friends could offer their perspectives on your decision. You may also want to discuss your participation with a patient support group or with other patients who have previously taken part in clinical research.

Consider whether the study procedures will be acceptable to you. For example, some trials may require a blood sample. You should not hesitate to ask the clinical research team any question you have about the study. The practical impact of participation on your daily life should also be considered. For example, you will need to find the time to visit the study site regularly. In some cases, you may have to find someone to drive you there or to take care of your children during those visits.

Clinical study participant checklist

• What is the goal of the study?
• What medication is being tested?
• If there is a control group, will they receive a placebo or another medication?
• Where will the study take place?
• How long will it last?
• What are the risks, if any?
• How will safety be monitored?
• What are the potential benefits?
• Can I choose to continue treatment after the study?
• Who will conduct the study?
• How is the research funded?
• Will I find out the results of the study when it is ended?

There are a number of benefits to participating in a clinical research study:

• will be assessed by highly-qualified medical professionals and receive high-quality care
• you may be one of the first people to benefit from a new drug that is not yet available
• your participation will be beneficial to the community as it will allow scientists and pharmaceutical companies to increase their knowledge of diseases and develop new drugs.

In some cases, volunteers or patients may consider that there was no benefit to taking part in a research study because:

• the treatment was not effective
• they experienced some side effects
• they were given the placebo instead of the active new drug
• they found the treatments, hospital stays and frequent trips to the study site to be demanding.

Participation in clinical research studies is voluntary. Participants may withdraw from a research project at any time.

The physicians or research staff conducting the study may perform a physical examination of participants. You may be asked to share information about your medical history, any medication you are taking, and other lifestyle factors such as whether you smoke or drink alcohol.
For each study, the details of what is required of participants is set out in the consent form you will be provided with.

 Informed Consent
Every year, millions of people volunteer for clinical research studies. Before agreeing to take part, you should know what is involved. The informed consent process ensures that you are fully briefed about the study and the nature of your participation, in both oral and written form.

The written informed consent document contains:

• information about the study (purpose, duration, placebo and all drugs used)
• study procedures
• potential benefits and potential risks

information about how your personal data will be used.

You will be given time to review the document at home. This gives you an opportunity to discuss it with your family or close relatives and come to your decision.

If you decide to join the clinical study, you will be asked to sign the informed consent document. You are still free to leave the study at any time.

Every effort is made to safeguard the safety of participants throughout the course of any clinical study. This is done through a series of tests which may include blood tests, physical examinations, CT scans or ECGs and by listening to the patient.
Any risk of side-effects during clinical studies is explained during the informed consent process.

A number of measures are in place to protect volunteers and patients participating in clinical research. These include the need for approval of clinical studies by Institutional Review Boards (IRBs) or Ethics Committees (ECs). These independent bodies review and advise on whether the proposed study meets ethical and scientific standards. The committee members are totally independent of the trial sponsor which means that they have no commercial or other interest in the trials.

All studies must be performed in line with Good Clinical Practice (GCP) or they will be rejected by the regulators.
Good Clinical Practice is the standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical studies. It provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of study participants are protected.

A customised protocol is developed for each clinical study. This document is designed to answer specific research questions and also has the safety of study participants in mind.

Study protocols include information on:

• who is eligible
• to participate (inclusion and exclusion criteria)
• the drug being tested and, if any, the comparator (another drug for the same condition or a placebo)
• the dosages
• the kind of tests that will be performed at each visit
• the trial duration.

Clinical investigators or medical researchers conduct clinical studies and follow the study protocol. They are usually doctors, nurses, pharmacists or other healthcare professionals. In keeping with Good Clinical Practice, the clinical investigator(s) is (are) qualified to take responsibility for how the study is conducted. The investigator must meet all the qualifications specified by regulators and provide evidence of their qualifications. They must also provide any relevant documentation requested by the sponsor, the institutional review board (IRBs) and independent ethics committee (ECs).

Information about your medical history and results of testing  conducted  is essential to research studies. Personal information is accessible to the researcher conducting the study. It may also be available to the sponsor or the contract research organisation managing the clinical research.

Summary results from each treatment group of the research study may be shared at scientific congresses and published in academic research papers. Clinical data may also be provided to regulators. Details of how personal data is managed is explained in the consent form that participants are asked to sign before the  study begins.

Clinical research takes time, expertise and resources. Research funding can come from a variety of sources including governments, medical institutions, foundations and private companies in the pharmaceutical and biotech sectors.

Clinical research study participation is voluntary and does not require payment. The new drug or the comparator are provided free of charge and in most cases, visits to the research center and associated procedures will also be free of charge.
In addition, you should be reimbursed for the costs associated with your participation in the clinical research such as for travel costs and parking.

When a study is finished, researchers analyze the information they have collected. This will reveal whether the drug was effective and safe, and whether any side effects were recorded.

At this stage, the researchers and sponsors of the study will decide whether to move on to the next phase. The finding may be submitted to peer-review journals and/or shared with regulators. If regulators approve the drug, further studies may be launched to compare the drug to other medicines, or to study its long-term effects or cost-effectiveness. Drugs that are approved can be made available to patients, according to the terms and conditions determined by the regulator.