Clinical studies are the backbone of drug development.
Have you ever thought closely about the contents of your medicine cabinet? The medicines inside may have different purposes, but they have one big thing in common before reaching you, they underwent years of scientific studies to ensure they were safe for you to take. These research studies are called clinical studies.
Clinical studies provide critical information about an investigational drug’s safety and effectiveness and generate in-depth data that can even lead to the creation of other innovative treatments. Every potential drug undergoes multiple phases of research, each with a different goal.
Ultimately, clinical studies make a difference not just for today’s patients, but also potentially to those who’ll be diagnosed tomorrow, next month, or even a decade from now.
The whole experience has been a joy and the personnel are all so professional.
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Phases of clinical studies
Clinical studies are usually conducted in three phases (I,II and III). Only a small number of volunteers, usually so called 'healthy volunteers’, participate in phase I trials, while the later phases involve a larger number of patient volunteers.
We focus on what’s known as “late phase” clinical studies. These studies look into the effects the treatments being researched have on the conditions they were designed to treat and all will have undergone some earlier phase testing.
Clinical studies have a regulatory and ethical framework to protect participants. Everyone conducting a clinical study has strict regulatory and ethical duties. To ensure these duties are followed and that participants are treated well, a team of people, who are independent from the research conduct, is asked to review and maintain oversight over each clinical study.
A clinical study can only be offered to our study patients once it has been approved by Pharma-Ethics Committee and SAHPRA, as well as an independent ethics committee who look to ensure that the rights and wellbeing of all study patients are not being compromised.
Many studies, particularly phase III studies are conducted worldwide with a large number of patients participating in them. They will have to be approved by the regulatory agencies in their countries (e.g the FDA in the United States) and the results collected from all study participants globally are monitored closely during the study process.
All our clinical studies are fully approved by both national and local ethics committees. As well as being rigorously monitored by both internal and external audits along with regulatory inspections throughout.
- How does a Clinical trial work?
In a clinical trial a volunteer is usually assigned randomly to a specific trial group. Volunteers in one trial group may receive the investigational treatment or trial drug while other volunteers may receive a placebo (dummy treatment) or another treatment that is already available.
A placebo is an inactive product used to assess the investigational treatments' effectiveness. The volunteer, the doctor and research team may not know which volunteer receives placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allow the research team to objectively observe the volunteers during the trial.
However, regardless of which treatment the volunteers receive, the level of medical care and attention is the same. All procedures eg. Blood tests, X-rays, MRIs etc, as required for the trial, will be conducted for all volunteers and they will attend all visits for the trial.
Not all trials have placebo’s and, in those trials, where placebo’s are used, in most cases there is the availability of ‘relief’ medication which is provided as a backup.
You should also be aware that you can withdraw from the trial at anytime if you so wish. Given this is the case, many patients who may have concerns with the prospect of being placed in the placebo arm of a trial, still consider it worthwhile to participate in the trial as it provides them the opportunity to obtain the investigational treatment and regular monitoring, whilst knowing they can always withdraw at anytime if their situation does not improve or if they do not consider the trial of benefit to them personally.
A number of clinical trials have extensions after the main trial has completed called Open Label Extensions. If a trial has this type of extension, all previous participants are offered the investigational treatment or trial drug. This applies to volunteers who may have had a placebo earlier, so this may be useful for you to know.
- Who can participate in a clinical trial?
Participation in a clinical trial is a personal choice and we will provide you with the information you require to make an informed decision. We encourage you to discuss your decision with those close to you.
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the trial. The factors that allow volunteers to participate in a clinical trial are called' inclusion criteria' and the factors that disallow participation are called 'exclusion criteria'.
These criteria can include age, gender, the type and stage of a disease, previous and current treatments and other medical conditions.
Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines work or not in a specific patient population and make sure the right participants enter the trial and stay safe. These criteria are applied to all potential participants equally before they start the study.
Participants can withdraw from a clinical trial at any time, even after they have agreed to participate. And they do not need to give a reason. No matter what stage of a clinical trial, participants have the right to change their mind. If a participant decides to stop participating, the Principal Investigator will remove them from the trial in a way that is safe for the participant
Participant health is important to the medical professionals who conduct clinical trials. One of the responsibilities of medical professionals who run clinical trials is to care for participants. These professionals may go by unfamiliar titles like, Principal Investigator or Study Coordinator. But they are, also, doctors, nurses, and trained research professionals. As such, these professionals monitor participant safety and well-being. Trial professionals will adjust study-related care when they feel it's in the participant's best interest. This may mean withdrawing a participant from a clinical trial. They will also often coordinate care delivery with the participant’s personal physician and healthcare team.
- What are the possible benefits of taking part?
The risks and benefits are different for everyone. Each clinical trial has different risks and benefits. And because all clinical trial participants are different, they will experience these risks and benefits in different ways. For example, one participant may experience a side effect that another participant does not.
Since clinical trials are experiments, the exact risks and benefits can be difficult to predict. But researchers only move forward with clinical trials when they are optimistic about the potential benefits and believe the risks for participants are acceptable. In addition, the Pharma-Ethics Research Ethics Committee and SAHPRA, as well as an independent ethics committee must review the research protocol, or plan, before researchers can enroll participants. Researchers inform participants about potential risks and benefits before they enroll in a clinical trial. This discussion takes place during what's called the Informed Consent process, which helps participants understand what's involved so that they can make the decision that’s right for them
The possible benefits for Volunteers include to:
- Play an active role in your health care.
- Gain access to research treatments before they become available, if approved.
- Obtain medical care at our dedicated research centre during the trial.
- Regular monitoring at trial visits and the results of any investigations such as XRays, MRIs, blood tests, etc being forwarded to your GP.
- Participate in the development of medical therapies that may offer better treatments for life threatening and chronic diseases
- Helping future generations with new treatments by contributing to medical research.
The majority of clinical trial participants would do it again. An estimated 2.3 million people <a>participated in clinical</a> trials in 2015. During that same year, a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) found that 98% of clinical trial participants would consider enrolling in another clinical trial. Additionally, 92% of respondents thought their clinical trial experience met or exceeded their expectations.
- How do I find out about current studies?
Volunteers usually contact us to find out more about the clinical trial they are interested in. You may have heard about the trial from your GP, the radio, the press, or our websites A member of our research team would then follow up your interest on the telephone to ask a few more questions because it is important that we learn more about you so that we can find the right clinical trial for you. If after the call, you seem eligible for the trial and are interested to know more, we will invite you to the Research Centre for a Patient Interest visit for you to discuss your potential participation further with one of our doctors.
If you decide you are interested in potentially taking part, we will make your journey as easy and informative as possible.
The majority of clinical study participants would do it again.
An estimated 2.3 million people participated in clinical studies in 2015. During that same year, a survey by the Centre for Information and Study on Clinical Research Participation (CISCRP) found that 98% of clinical study participants would consider enrolling in another clinical study. Additionally, 92% of respondents thought their clinical study experience met or exceeded their expectations.