clinical trial rundown
What is a Clinical Trial?
Clinical trials are carefully designed research studies that evaluate investigational treatments for diseases. The purpose of a trial is to test the safety and results of medications or treatments not yet approved and available to the general public. They are regulated by the Food and Drug Administration (FDA) and overseen by science and medical experts, who ensure the trials are safe and designed appropriately.
There are phases to a study, so each study medication is not evaluated just once before it is considered safe for use.
- Phase I is a study typically done on 20-80 healthy participants, to establish how the study medication, for example, metabolizes and the reactions of different dosages.
- Phase II trials further define the safety of the therapies and are usually conducted on a larger number of participants, 100-300 people.
- Phase III are longer, more involved trials, with even larger populations of participants (1,000-3,000). Many of these are known as “double-blind” studies, (a type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over) and determine the actual benefit of the study treatment to the patient and whether the benefits outweigh the risks.
- Finally, if the investigational treatment meets all goals set for each and all previously mentioned phases, it is up for approval from the FDA. Phase IV trials test the effect of different dosages in patients and provide more data on long-term effects.
Consent
Federal guidelines state that each participant in a clinical trial must be given very in-depth information about the trial before agreeing to participate. Legally, this is known as “informed consent.” The informed consent process is very long and thorough. The study staff will give in-depth details to the patient, caregiver and loved ones about the purpose and length of the study, the benefits and risks, confidentiality and much more. This is done so trial administrators can ensure each participant is doing so voluntarily with complete awareness of what to expect. Both caregiver and loved one should know that informed consent is NOT a contract and the participant can withdraw from the study at any time.
Pros and Cons
Many people choose to participate in clinical trials because they feel compelled to act for the greater good. They believe that taking this one step could be beneficial to future patients.
Being a part of a clinical trial can change the schedule of a loved one and most likely, a caregiver too. Depending on the nature of the trial, a loved one may need extra help with transportation to and from multiple appointments. A trial participant still works with their primary medical provider as well as the study team.
A Caregiver’s Role in a Clinical Trial
Communicating During the Study
When your loved one is a study participant, communication is essential. Make sure to talk often about their feelings throughout the study. Be aware of what your loved one is thinking and feeling. You should discuss feelings when they arise, while appreciating the need for personal privacy. Remember to always respect your loved one’s ability to make their own decisions.
Recognize that negative emotions can arise for both you and your loved one. It is OK for either of you to feel sad or frustrated. Expressing these emotions is, in fact, healthy and normal.
Other ways to keep communication flowing smoothly:
- Encourage your loved one to keep a journal. You can also discuss your loved one’s diary entries for the study or help your loved one to fill out the diary.
- Set aside time each day or week to talk about the most recent study visit. Learn basic relaxation techniques to keep tension and stress low.
Supporting Your Loved One
Those who participate in clinical trials must be sure to take the study medication as instructed. If the instructions are not followed correctly, doses are missed, or study medications run out, then the research results could be negatively affected. It could even affect the health of your loved one. It also undermines the very reasons your loved one volunteered for the trial.
- Seek advice on how to organize your loved one’s medications.
- Create a system to ensure study medication has been taken.
- If using a weekly pill organizer, include the study medication for each day. Make sure refills are received at each appointment.
- Don’t let your loved one skip an appointment because they could run out of study medication.
Clinical trials are an essential part of medical advancements and these advancements only come when people step up to participate. Being a part of a clinical trial can take extra time and effort for both caregiver and loved one. The key is to find a trial that is attainable and one that fosters a sense of purpose in one, especially someone afflicted with a debilitating disease. Knowing that they can still make a difference for themselves and others may be just the positive reinforcement a loved one needs.
To learn more about melanoma clinical trials, visit BMSStudyConnect.com. The site provides patients and caregivers with information about how clinical trials work and how they might be part of making sure new medicines are effective and safe.
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