Clinical Trials 101
Each clinical trial is unique in its own way; no two trials are the same; however, despite their uniqueness, clinical trials are structured similarly and as described above, contain a number of common elements and requirements.
The summary below provides an example of what a potential clinical trial participant might experience throughout the trial, from start to finish.
Overview: Clinical Trials from Start to Finish
1) Potential volunteers may be approached about participating in a clinical trial by a study recruiter or their doctor, or they may see the clinical trial advertised in the news media or on a flyer. In such instances, those interested in participating in the clinical trial are given a phone number to contact the study recruiter.
2) Once the initial contact has been made, the study recruiter will provide a brief overview of the clinical trial, and he or she will likely ask a few preliminary questions to determine if the volunteer meets the basic inclusion criteria for participation.
If those criteria are met, the study recruiter will schedule a visit with the volunteer during which he or she will obtain more detailed information and further assess the volunteer’s eligibility for the clinical trial.
3) At this in-person visit, the volunteer will mostly likely complete some paperwork, which will include the informed consent document and any other forms that may be required as part of the clinical trial (i.e., questionnaires, privacy information, and other trial-related documents).
Someone from the research team will be present to assist the volunteer in completing the forms and answering any questions that they may have. The volunteer will be given a copy of the consent form to take with them for their records.
4) After signing the informed consent document, the volunteer may be asked to complete certain screening tests or procedures that are a necessary part of the clinical trial.
All of these will be detailed in the informed consent document, including their frequency and why they will be performed. In addition, the informed consent document will also provide an overview of what will occur during each test or procedure.
Typical Screening Tests and Procedures for Clinical Trial Participants Include:
- Blood tests
- Urine tests
- Pregnancy test
- Body mass index (BMI): a screening tool used to determine an individual’s body mass based on their height and weight
- Electrocardiogram (EKG): a recording of the heart’s electrical activity
- Magnetic resonance imaging (MRI): a non-invasive imaging test that makes detailed pictures of internal body structures using a combination of magnetic fields and radio waves
- Computed tomography scan (CT or CAT scan): a computerized x-ray exam
- Biopsy: surgical removal of a small amount of tissue for the purposes of examining with a microscope or other analysis.
It is important to note that the type of test and procedures involved will vary greatly depending on the nature of the clinical trial. Some trials may utilize few if any tests or procedures, whereas other, more complicated treatment studies may involve a considerable number of tests, procedures, and exams. Again, everything that will occur as part of the clinical trial will be clearly listed in the informed consent document.
5) Clinical trials will vary in length. Some will be short-term and others long-term. Others may be designed to be completed by patients in the hospital (known as inpatient studies).
Short-term studies may be completed in as few as one or two visits, possibly even the day that the subject signs the informed consent document. Long-term studies will involve more testing, assessments, and follow-up period, and may last for several months or even several years. Inpatient clinical trials will often be incorporated into the patient’s routine care.
Often, inpatient studies ask a patient to allow for something as simple as one extra procedure beyond what they would normally receive (i.e., an additional MRI). The length of required participation in the clinical trial will be clearly described in the informed consent document.
6) The exact nature of each clinical trial will vary. Some trials may require participants to take trial-related medications at specific time intervals and then return to the clinic for blood tests and other assessments.
Other clinical trials may also involve the use of additional assessments, such as questionnaires given at specific intervals. In addition, some clinical trials may involve the use of follow-up phone calls from a research nurse or other research team member at various time points.
During these phone calls, the research staff may ask the participant about any side effects they have experienced, administer questionnaires over the phone, and ask other trial-related information.
Regardless of what happens during the trial, all of the requirements for participation, as well as the schedule of all trial-related screenings, interventions, and assessments, will be clearly described in the informed consent document.
7) Participants will be notified by the research staff when their participation in the clinical trial is complete.
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