Expression of interest in a clinical trial – Do you want to contribute to ground-breaking medical research?  By contributing to medical research, you are helping find new and improved treatments for a variety of conditions.

Pre-screening activities in a clinical trial consist of any of the steps conducted prior to a patient giving consent to participate in a trial. Pre-screening often takes place over a phone call or brief communication and typically include a general overview of the clinical trial for the patient as well as pre-screening questionnaire.

It aims at gathering information pertaining to a patient’s eligibility to determine if they are a good fit for further screening.  These questions are primarily based on the trial’s inclusion and exclusion criteria.

Obtaining informed consent is a prerequisite for ethically valid clinical research.  Informed consent means that a patient is given all the available information about the procedures, risks and benefits and obtaining the consent of the subject or legal guardian in writing. The doctor conducting the clinical trial and the study coordinator is responsible for explaining the study to a patient. This allows the patient the opportunity to digest the study process and formulate any questions they may have.

Screening is the term used to describe activities performed after obtaining patients consent to ascertain eligibility for the study. During the screening visit, the participant will meet the study staff, the doctor, and the clinical trial coordinator. The investigator (the doctor) will go through a series of assessments required by the clinical trial protocol, for example: physical exam, vital signs, weight, height, review of medical history & current medications etc. The information collected at this visit forms the baseline data.

If the patient meets all the criteria for enrollment into the study they are then invited back for the randomisation visit. Some participants will not meet all the requirements for study inclusion and may end their study involvement prior to treatment commencement.

Randomisation is the process of randomly allocating participants to treatment / control / comparison groups (also known as “treatment arms”). This is generally performed by a computer program.

Randomisation ensures that the process of selection is unbiased, that the groups are balanced.

Participants will be required to attend regular, scheduled follow-up study visits. The number of visits and length of time between visits depends on the treatment and the trial design. During these visits, more data will be collected in the form of questionnaires, and perhaps physical examination and/or blood tests and/or medical imaging.