Clinical trials or studies allow real people to participate in research as volunteers to improve our understanding of disease and develop new treatments and medications through clinical trials.
Clinical research is the study of health and illness in humans. It aims to improve our understanding of diseases, develop new diagnostic methods, and create better treatments or medical devices for improved patient care.
Clinical research trials are carefully designed, reviewed, and approved before they can begin. The National Institutes of Health and the U.S. Food and Drug Administration monitor these trials closely to ensure safety and effectiveness. A clinical center’s research studies may directly benefit patients with promising new treatments.
In summary, clinical research is a vital process that helps improve medical knowledge, requires competent conduct with participant protection, follows regulatory and legal/ethical requirements, and ensures informed consent.
All clinical research must meet the following criteria:
Aims to advance our understanding of health and disease to benefit patients and society.
Be conducted by qualified and competent individuals who take all necessary measures to protect the well-being of the participants.
Must obtain all required regulatory approvals and follow all necessary legal and ethical steps to ensure compliance with applicable laws and regulations.
Must obtain informed consent from all individuals who participate in the study, ensuring that they understand the research's purpose, risks, and benefits and voluntarily choose to participate.
Clinical trials play a vital role in discovering new medicines and treatments for diseases, and there are several compelling reasons why people choose to volunteer. When you volunteer:
You’re contributing to medical advancements, and you have the opportunity to help the development of new treatments, devices, or preventions for specific diseases or medical conditions.
You may gain access to investigational treatments before they are available to the general public, offering a chance to receive cutting-edge therapies that may not yet be accessible through other avenues.
You participate in free diagnostic procedures or medical tests related to the trial at no cost, which can be beneficial for monitoring health and receiving valuable medical services.
You receive compensation for the time and travel expenses associated with participation, which can help offset any inconvenience or costs incurred during the trial.
On many occasions, we work with medications that are already FDA-approved, and in particular study designs, there are no placebos. In these cases, every patient enrolled gets the active study drug.
Clinical trials have specific criteria, including "inclusion criteria" and "exclusion criteria," which determine who can participate. Inclusion criteria are the factors that allow someone to participate, while exclusion criteria are the factors that may prevent someone from participating. These criteria are based on various factors, such as age, gender, disease type and stage, treatment history, and other medical conditions.
Some research studies may seek participants with specific illnesses or conditions, while others may need healthy participants. It's important to note that these criteria are not used to reject individuals personally. Instead, they are used to identify appropriate participants with consideration for their safety and the study's objectives. The study coordinators can answer any questions about the trial and provide further information about the criteria and eligibility requirements.
Patients generally don’t have to pay out-of-pocket costs for treatments studied in a clinical trial. Each trial may have different arrangements, but the clinical trial's sponsor typically covers all research-related expenses. This may include the cost of the investigational treatment, study-related tests, procedures, and follow-up visits. It's important to discuss the financial aspects of the clinical trial with the study coordinators to understand what costs, if any, may be associated with participation.
Clinical trials may include compensation for your time. The amount will vary from trial to trial.
Yes, we always tell our patients to continue seeing your primary care physician (PCP) during your participation in the clinical trial. The research team will notify your PCP of your involvement in the trial to ensure coordinated and comprehensive care. Your PCP can work with the research team to ensure that any other medications or treatments you may receive do not conflict with the clinical trial protocol. It's important to maintain open communication with both your PCP and the research team to ensure your overall health and well-being are taken into consideration throughout the trial.
Informed consent is the process that ensures you have all the necessary information to make an educated decision about participating in a clinical trial. The informed consent document summarizes the trial, including its purpose, what will happen during the trial and when, potential risks and benefits, and alternatives to participation. It also explains your rights as a clinical trial participant.
Participation in a clinical trial is voluntary, and you are under no obligation to participate if you do not wish to do so.
Before you decide to participate in the trial, the research team will provide you with information to help you make an informed decision. You will have opportunities to ask questions before, during, and after the trial. If you choose to participate, you are required to provide your official consent by signing the informed consent document. It's important to note that even after signing the informed consent, you have the right to leave the trial at any time and discuss other treatment options with the medical staff.
The safety and well-being of clinical trial participants are paramount for us and are ensured through various measures, including:
Independent Ethical Review: All clinical trials conducted in the United States must be reviewed and approved by an independent ethical review committee known as the Institutional Review Board (IRB). The IRB is composed of individuals from various professions, such as doctors, teachers, and religious leaders, who have no affiliation with any pharmaceutical companies. The IRB evaluates all aspects of the research trial to ensure that it follows the guidelines and procedures required to protect the safety and well-being of participants.
Informed Consent: Participants in a clinical trial are provided with an informed consent document that provides detailed information about the trial, including its purpose, procedures, potential risks and benefits, and their rights as participants. Participants are required to provide their official consent by signing the informed consent document after being fully informed about the trial.
Ongoing Monitoring: Clinical trials are continuously monitored by the research team and the IRB throughout the trial to ensure that the trial is being conducted in compliance with the approved protocol and regulations. Any concerns or adverse events reported by participants are promptly addressed by the research team.
Safety Measures: Clinical trials have strict protocols in place to ensure the safety of participants. This may include regular medical assessments, monitoring of adverse events, and adjustments to the trial protocol as needed to protect participant safety.
Regulations and Guidelines: Clinical trials must adhere to strict regulations and guidelines set forth by regulatory agencies, such as the Food and Drug Administration (FDA), to ensure the protection of participant rights, safety, and welfare.
Overall, clinical trial participants are protected through rigorous ethical and regulatory oversight to ensure their safety and well-being throughout the trial process.
Before participating in a clinical trial, it's important to understand the risks and benefits, eligibility criteria, study procedures, alternative options, the potential impact on daily life, confidentiality and privacy measures, support system, follow-up care, and the right to withdraw at any time.
Thoroughly review the informed consent document, ask questions, and discuss with your healthcare provider and trusted individuals. Make sure you meet the trial's requirements and are willing and able to commit to the time and effort required for participation. Consider the potential risks and benefits carefully, and ensure that participation aligns with your health needs and personal circumstances.
Certainly! You have the right to withdraw from a clinical trial at any time and for any reason without facing any penalties or negative impacts on your usual medical care. Simply inform the research team of your decision and the reasons for withdrawing. Your decision to leave the trial will be respected, and it will not affect the care you receive from your regular healthcare provider.
Randomization in a clinical trial refers to the process of randomly assigning participants into different groups, which may receive different treatments or interventions. This is done to ensure that the assignment of participants is unbiased and not influenced by any external factors.
In some trials, participants may be randomly assigned to a "control group" that receives either no treatment or a standard treatment already available in the market, while other participants may be assigned to a "treatment group" that receives the investigational treatment being studied.
Randomization helps to eliminate potential bias and ensures that the results of the trial are valid and reliable. The study staff will provide you with more information about the different groups and treatments being investigated in your specific trial.
If you get injured during a clinical trial, the first thing you should do is to seek medical attention right away. Don't wait! The people in charge of your study have specific procedures in place for managing adverse events, which include injuries. You'll want to tell the study staff about your injury as soon as possible so that they can help you get the right medical care.
The clinical trial sponsor is responsible for providing medical treatment for any injuries or complications that occur during the trial. They may also have insurance coverage that can help pay for any medical expenses related to the injury.
It's important to understand that clinical trials are designed to minimize risks to participants, and study staff will do everything possible to ensure your safety. However, all medical procedures and treatments come with some level of risk, and injuries can occur, even in the best circumstances. If an injury happens during the study, the sponsor may be required to provide compensation or other benefits to the injured participant.
A placebo is a type of treatment that resembles a regular treatment but contains only inactive ingredients, which do not affect patient health. Researchers use placebos in some clinical trials to ensure accurate results.
Depending on the trial design, if you are assigned to a placebo study, you may take it for a few weeks or for the entire duration of the study. These designs are created by pharmaceutical companies, and reviewed and approved by the FDA. Placebo studies are an integral part of clinical research as it allows scientists to assess whether the medication actually works or not.
If you are considering participating in a clinical trial, it’s important to understand what placebos are and how they’re used. This knowledge will help you make an informed decision about whether or not to participate and which trial is best for you.
Based on the protocol design, the participants are usually allowed to take some background or rescue medication for their situation, which can provide some relief, even if you are randomized to a placebo study.
Me siento mejor y esperoq u e con el tiempo me sentiría mejor. El beneficio más grande que ha recibidoes que sientomenos dolor.Yo recomendaría este estudio a personas que tengan artritis para que mejoren sus dolores. Con todo el personal me siento feliz. Son muy amables y me ponen mucha atención. Espero sentirme mejor y que este estudio me ayude a mejorar mi artritis reumatoide y ayude a mas gente con mi mismo problema. ¡Gracias!
My life has changed in a huge way as the pain in my feet and knee has stopped and it has made a positive difference in my life after joining the study. My greatest experience is being able to do more physical activities with my special needs son. I would definitely recommend this to others. Every step is worth it to live a pain free life. The staff at Medvin is very knowledgeable and patient with us. The results speak for themselves and I'm very happy that I chose to participate in this trial.
I would like to talk about my experience with this service that I’ve been receiving at Medvin at Covina, CA. They are the greatest! Since I started my participation in the study, I have noticed a huge difference in the mobility. I can finally do the things again that I haven’t been able to do in a while. The best part of this service is that the medicine is free and the medical care is free. The staff is very kind and understanding. I have recommended them to a lot of people to help them as well.
Baldwin Park, CA
Yo he vivido con la enfermedad espondiloarthritis anquilosante por 26 años. Yo he tratado diferentes tratamientos y creo que fue el destino que puso este medicamento en mi camino. Con este nuevo medicamento, me he sentido mucho mejor. Ahora tengo menos dolor, inflamación y rigidez. Yo les recomendaría a otras personas con mi misma enfermedad tratar este medicamento, porque me ha ayudado recuperar mi vida. Le agradezco al equipo de Medvin y a la Doctora Chen por haber mejorado mi vida.
Prior to entering the study it would take me about 30 minutes to get out of bed due to the morning stiffness in my joints. I am now able to get out of bed without any pain. I am able to go to the YMCA and workout. I am also able to work on my house and daily chores. Dr. Gelfand and the Medvin staff have been great with my care and they are always very pleasant while attending to my study visits.
El Dr. Gelfand a sido mi doctor por varios anos ya y siempre me a dado el mejor cuidado medico posible. Desde que entre al estudio clinico me e sentido mucho mejor y puedo hacer mas de mis cosas dia a dia sin dolor de mis coyonturas.
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Imagine a Healthier You
Did you know participating in clinical trials has numerous advantages beyond feeling better? Join one of our studies, and you’ll receive the following:
Patient-centered care for your condition with licensed experts and professionals
Reimbursement for up to $3,500 for your participation, time, and travel
Diagnostic and laboratory tests plus medications and devices
Helpful treatments before they’re commercially available
Safety assurance with regular follow-up monitoring and check-ins
Control of your health with no financial liability or insurance required