Each clinical trial has a list of things which you need to have to be included in the study which are explained in the study protocol. A protocol is a study plan, and this is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people can participate in the trial; the schedule of tests, procedures, medications, and dosages and the length of the study. 

There will be pre-screening questions carried out by the EMS Healthcare team which will help us to see if you can be included in the study. These may include questions about your age, gender, medical history, and current health status.   

Because of these specific criteria, not everyone who applies for a clinical trial will be accepted. 

Healthy volunteers often participate to help others and contribute to the advancement of medicine.  Individuals with an illness or disease often join research studies to possibly receive a new treatment that may or may not be better than those that already exist, and to benefit from additional care and attention from the clinical staff, while helping to improve human health and well-being for generations to come. 

As a study participant you can also help others better understand how the treatment works in people of different races and genders because different people may respond differently to the treatment being investigated. Regulatory agencies such as the UK Medicines and Healthcare Products Regulatory Agency (MHRA) seek to ensure that people of different ages, races, ethnicities, and genders are included in clinical trials. 

Participants should carefully weigh up the risks and benefits and you may wish to seek advice from your doctor before taking part in a trial. 

The clinical research team will keep your personal information confidential. Your information will not be shared without your permission, except when required by law. 

If you choose to submit your information via the EMS Healthcare website, the proposed use of your personal data is solely to contact you to check if you may be suitable for future clinical trials and to inform you about those clinical trials.  Your consent to share personal data is entirely voluntary and you may withdraw your consent at any time by contacting gdpr@ems-healthcare.com.

If you do consent to take part in a clinical trial at EMS Healthcare, we are required to keep your details. We may need to contact you in the future to inform you of important new information related to your participation in the trial. Once you have been informed and provided any additional consent, your personal data will become part of the clinical trial records, and will be processed and shared in compliance with the applicable laws governing clinical trials.  Full details will be provided before you agree to participate in a trial. 

Studies into medicines devices or procedures are conducted in various phases to find different kinds of information. 

There are four main phases: 

Phase I/Phase 1 trials test an experimental treatmentor device in a small group of people (often healthy volunteers) to look at safety, identify side effects, determine safe dosages and look at how the medicine being studied is absorbed and handled by the body. Phase 1 clinical trials generally take several months to complete. 

Phase II/Phase 2 trials involve larger groups of people than Phase I and they are designed to assess whether an experimental treatment is safe and whether it works in those people with the condition being studied.  These clinical trials are sometimes randomised controlled trials where one group of patients receives the experimental treatment, while another group (the “control group”) receives a standard treatment or placebo. Placebos are inactive substances. In a clinical trial a placebo, made to look like the investigational treatment, is sometimes used to compare against the actual investigational treatment.  These studies are often “blinded” which means neither the patients nor the researchers know who is receiving the experimental treatment,to remove any potential bias in the comparison.  Phase 2 clinical trials usually take up to two years to complete.  

Phase III/Phase 3 trials are usually large studies comparing the experimental treatment to a placebo or standard treatment, to evaluate whether the drug works and collect information to allow it to be used safely.  These studies can involve thousands of patients with the disease, and the information will be used to determine whether the experimental treatment should be approved by regulatory authorities and marketed. These trials are usually randomised and blinded trials that generally takes up to several years (1-4 years) to complete. 

Phase IV/Phase 4 trials are performed once a drug has reached the market, to provide additional information about the best use of the drug.  These clinical trials involve people in various populations and are generally intended to collect additional information after the drug is approved and marketed regarding its risks, benefits and use in various populations over a longer period of time. 

Each study is different, but the informed consent process ensures you understand the experimental treatment, device or diagnostic being studied, your role in the trial, potential side effects, and the visits required. In some studies, you may receive a placebo, whereas other studies will not involve medications.

In addition to the drug, device or diagnostics being tested, the trial may require that you have further assessments and exams. These will be described during the informed consent process.  

The following process generally occurs during the conduct of a clinical trial: 

Pre-Screening 

The clinical research group will review their existing patient databases or medical charts to identify potential patients who may be suitable to participate in the clinical research study. They may also place advertisements on the internet, newspaper, radio, or television to recruit interested participants, and may hold in-person events to make people aware of the research study.     

Potential participants from these pre-screening efforts are contacted and briefly interviewed to confirm if they can potentially be included in the clinical research study. 

Informed Consent 

If you are potentially suitable to participate in a clinical research study, an appointment will be scheduled for you to come to the clinical research site and meet with one of the research staff members, or if the study allows, to speak to them on the phone. Before any study related procedures are performed you will be required to sign an informed consent form which describes the study design, risks and benefits, your rights as a study participant and who to contact in case of an emergency. During the informed consent process, you will have an opportunity to ask questions you may have regarding the study and your participation. You should receive a copy of the signed informed consent form to keep for future reference. 

Screening Visit 

Once you agree to participate in the clinical research study and have signed the informed consent form, the study screening procedures will be administered. The purpose of the screening visit is to determine if you meet the specific inclusion and exclusion criteria for the specific clinical research study you agreed to participate in. Generally, during the screening visit you may be asked to answer questions regarding your medical history, medications and other treatments you are taking, and complete questionnaires. A member of the research team may also assess your general health by performing a physical examination, and collect blood/urine samples. 

Study Visits (Treatment Visits) 

If you meet the specific inclusion and exclusion criteria (which may include a study acceptable laboratory and medical results) for the study you will be asked to return to the research clinic for a series of study visits sometimes referred to as Treatment Visits. It is generally during these study visits that you would receive the experimental treatment or the comparator product (which sometimes can be a placebo). The number of study visits and the timings of those visits varies from study to study. 

End of Study Visit 

Once you have reached the end of the treatment visits, an End of Study Visit is conducted. Generally, the same or similar assessments conducted prior to you starting the study are repeated. The research team will also discuss your follow-up treatment options (which may include receiving standard of care treatments for your illness) and if required by the study you may be asked to return to the research site for a follow-up safety visit. 

Follow-up Safety Visit 

The number of follow-up safety visits and the interval in which the visits occur varies from study to study. The purpose of this visit is to ensure you are not experiencing any ongoing side-effects from the experimental treatment or from the overall participation in the study.