What You Need To Know About Volunteering in Clinical Trials?
Volunteers or participants interested in joining trials help find potential new treatments for diseases and conditions. People who participate in research studies have their reasons that range from helping advance medicine to gaining access to new treatments that are otherwise not available in the market. Participants weigh the potential risks and benefits before making an informed decision. For newbies interested in participating in clinical trials, the entire experience can be a little intimidating and overwhelming, especially when you don’t understand the processes and what enrolling in research studies entails.
Here’s a little insight into the world of clinical trials and what you can expect.
What are Clinical Trials?
Clinical trials are research studies that help us understand disease conditions and their treatments. At large, these trials help bring treatments and therapies one step closer to patients and people who need them. These research studies undergo meticulous scrutiny from review boards and the FDA to ensure that the medicines, treatments, or medical devices are safe and effective for people to use. Medicines and treatments available today are because of the people who have participated in research studies to make it so. Scientists and researchers from clinical research organizations and pharmaceuticals are constantly looking for ways to treat illnesses better.
Why do People Volunteer in Clinical Research Studies?
There are many reasons volunteers might consider participating in research studies. People interested in joining research studies assess the potential risks and benefits associated with enrolling in a trial before participating. Some of its benefits include:
1. Gaining access to new potential treatments
People volunteering in trials gain access to potential new or alternative treatments that are not yet available in the market. The same goes for medical devices that may be able to improve the quality of life. Many of these new, potential treatments help people live healthier lives, as functioning members of society. That’s the goal of every experimental drug tested out in clinical research, to improve lives for the better.
2. Helping others with your condition
When people participate in clinical trials, they don’t just help themselves. They help communities by helping bring life-changing, experimental treatments to the market. For many, making treatments available for future generations is what motivates them to take part in research studies. Usually, investigational treatments take 12 years to make it from lab desks to pharmacy shelves. Expediting and working within timelines is only possible with the help of volunteers. You hold the power to bring a difference in the lives of the people around you and for future generations.
3. Gaining access to healthcare from experienced doctors
Clinical trial volunteers gain access to care from doctors and research staff who are scientific leaders in their fields. Participants also receive the extra attention that they may otherwise not receive from a normal doctor’s appointment. If you suffer from chronic or rare conditions and decide to join a clinical trial, you will receive care from expert doctors and physicians specialized to treat your condition.
4. Gaining access to medications for rare conditions
For people suffering from rare or chronic conditions, clinical trials provide an option that could potentially help treat their condition. Clinical researches provide treatment options for rare conditions that are either not included in standard care or may not exist. For example, after exhausting all treatment options, cancer clinical trials could provide hope and alternative treatments to people suffering from late-stage cancers.
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5. Earning compensation
Many clinical research organizations in the US offer monetary compensation to participants who decide to take part in clinical research. CRO’s and pharmaceutical companies offer a chance to earn for people interested in participating in these research studies. Even trials that don’t offer monetary compensation do reimburse volunteers for their travel expenses. If you qualify and decide to participate in a research study, the research staff will discuss with you the details of the study, including the treatment, the visit, risks and benefits, and compensation.
Are Clinical Trials Safe?
All clinical trials follow very strict standards that are put in place by the FDA (United States, Food Drug Administration) and are closely regulated to ensure participants’ safety. All clinical research trials follow a written plan i.e. the protocol which is approved by the FDA and other regulating bodies like the Institutional Review Board (IRB). To ensure the protection of participants’ rights, safety, and well-being, a clinical research organization in US must adhere to guidelines and regulations set by the IRB. Good Clinical Practice is one of them (GCP). GCP is an international ethical and scientific quality guideline for designing and carrying out human research studies. Before participating in any research study, the research staff will take you through the potential risks and benefits of the study and will answer any questions you might have.
What Should Volunteers Expect?
If you qualify for a study and decide to participate, the research staff will discuss in detail the study treatment, the potential risks, and benefits, and questions you may have about the study trial. This is known as the Informed Consent Process. Many research organizations encourage participants to ask as many questions as they’d like before signing an Informed Consent Form. The Informed Consent Form has all details about the study and it’s a document that safeguards your rights. Throughout the study trial, you can expect visits to the study clinic, check-ups from the study doctor, collection of bodily samples (if needed), and phone calls to ensure your safety.
Participating in Clinical Trials is a Choice
Participation in any clinical trial is completely voluntary. You can end your participation at any time, for any reason. Throughout the study, the research staff maintains Informed Consent where volunteers are provided with any new information learned throughout the study. And remember as the volunteer, you hold the power.
Making an Informed Decision
Deciding to participate in a clinical trial is a very personal decision and we encourage anyone interested to discuss the decision with your family, and doctor. Take as much time as you need to make an informed decision. Joining a clinical trial might be a scary prospect for many, however, these experimental medications undergo years of testing in the lab before they reach the clinical trials phase.
