Clinical Trials – Becoming A Volunteer
If you are considering volunteering for a clinical trial, be sure you are making a knowledgeable assessment. Here are some answers to frequently asked questions volunteers have about participating in a clinical study.
Clinical trials are medical research studies in which participants are given investigational treatments under the direction of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians to conduct trials to establish the benefits of investigational treatments and drugs.
Clinical trials are conducted in four phases (I, II, III, IV).
All trials have guidelines regarding those who can participate. Before becoming a clinical trial, a volunteer must qualify for the clinical trial. Before you can be admitted as a volunteer you will be screened by a CRC (Clinical Research Coordinator) for factors that are called "inclusion criteria" and also for factors that may exclude you from the study, called "exclusion criteria.” Criteria will include age, gender, the type and phase of a disease, treatment history, as well as other medical conditions. . Inclusion and exclusion criteria are used to identify suitable volunteers, support their wellbeing, and make certain researchers can identify the data they need to determine the effects and safety of the treatments.
Trials look for participants with particular conditions or illnesses to be studied, as well as for participants suitable for other studies.
The Clinical Trial Process
Volunteers are usually assigned to specific study groups. One study group could be given an investigational treatment or study drug while others may be given a placebo or a current treatment that is already accessible.
Placebos are inactive products used to evaluate the investigational treatment's effectiveness. Usually you, the physician, and the investigative staff will not know if you have received a placebo or the active study treatment, allowing the principle investigator and research staff to independently monitor any effects on the volunteers during the study. Whether each volunteer receives the placebo or the active product treatment, they will receive the same professional and certified medical care.
Some questions you should ask the principle investigator or the clinical research caregiver:
- How long is the trial?
- Where will the trial take place?
- What are the treatments and how are they administered?
- What is the primary reason for the trial?
- How is the patient safety and wellbeing monitored?
- What are the risks?
- If I am harmed by the study, what happens?
- Are there possible benefits?
- Are there other treatments other than the one being studied in the trial?
- Who is the trial sponsor?
- Will I receive remuneration for participating in the trial?
- After the termination of the trial, can I remain on the treatment?
Patients participating in a clinical trial should discuss it with their doctor. Possible volunteers should also know the experience and credentials of the principle investigator, clinical research staff, and the facility in which the study will be conducted.
What volunteers can expect if chosen as a participant
In a number of studies, participants obtain:
- A physical examination
- Medical history review by study caregivers
- Monitoring of health during and after the trial
- Detailed clinical trial information
- A thorough explanation of what is expected of participants
- An explanation of “informed Consent” forms
- Withdrawal from a study is allowed at any time and for any reason
Confidentiality of information
Volunteers’ information will be made available to the investigator and research team conducting the clinical trial. The IRB (Independent Research Board) supervising the research, and the sponsor or CRO (Contract Research Organization) coordinating the study, may also have access to personal information. This will be covered in detail within the Informed Consent Form.
Study researchers are required to give progressive reports regarding the outcome of the trial at scientific meetings, to various government agencies, and may be reviewed in medical journals.
After the Trial
When a study is completed, the data is collected and reviewed to establish the treatment’s effectiveness, insure it is safe and what, if any, side effects may be caused by the treatment. After reviewing the results, researchers will then determine whether to continue the study and proceed to the next phase or to stop the study.
Clinical Phases - Wikipedia