Clinical trials are a key stage in the research process used to develop new treatments and advance the cause of medical science. As such, they underpin all the work done by medical and healthcare professionals, including nurses. The findings and results of clinical trials are used by nurses to provide the highest level of patient care and to help them educate patients so that they can make informed decisions about how to proceed.
In addition, nurses are increasingly required to undertake their own research or to base their practice on recent research findings. In a modern healthcare system, the overwhelming emphasis is on evidence-based practice, where decisions about patient care are informed by the best available evidence. This evidence is produced by research undertaken by nurses and other medical professionals.
Most advanced practice nursing requiresa degree of first-hand research to qualify. One way of meeting these requirements is through participation in clinical trials as part of a research team. Nurses continue to play a vital role in clinical research and especially in clinical trials.
What are clinical trials?
Clinical trials are used to test and develop new drugs and treatment strategies for a diverse range of diseases, conditions, and ailments, both physical and psychological. These trials are conducted by nurses and researchers on patient volunteers, both those suffering from the condition that the treatment is intended for, and healthy individuals without any illness. A selection of people of different ages, backgrounds, and health profiles is required to attain a full picture of a given treatment’s effectiveness, as well as to identify any drawbacks or areas of concern.
Besides drugs, other interventions tested during clinical trials could include devices like pacemakers, psychiatric talking therapies, or even a diet plan designed to help with certain conditions. The objective is to make sure that the treatment is safe and effective before approving it for wider use. Often, it will already have gone through rigorous laboratory testing before clinical trials on human volunteers begin, and the safety of the volunteer ‘guinea pigs’ will remain paramount throughout.
Methods of clinical research
Clinical trials are one of the two cornerstones of clinical research into human health, the other being observational study. In observational studies, researchers monitor volunteers as they go about their ordinary lives, asking relevant health-related questions and performing occasional non-invasive tests. For instance, researchers may keep a record of patients’ pulse rates or ask them to take regular memory tests. Observational studies don’t involve the use of drugs or interventions but can be useful in developing treatment strategies or uncovering ways to prevent certain conditions or illnesses.
Even when scientists have determined that a treatment is theoretically safe and effective, testing on different groups of people in a controlled setting for a predetermined period is essential for scientific, ethical, and legal reasons. The results of the trials are then collated and studied, and the treatment is only made generally available if the trials show that it meets the expected standards.
What clinical trials are used for
Medical breakthroughs like vaccines, chemotherapy, and antibiotics were all created using clinical trials. However, most clinical trials don’t involve a completely new process. Rather, they are usually new refinements of an existing treatment that researchers hope will be more effective or have fewer unwanted side effects than its predecessors.
Nurses and scientists can also use clinical trials to test preventative approaches. Improved early diagnosiscan potentially halt debilitating conditions in their tracks. One example of how clinical trials can be used to achieve this is in testing a blood test to diagnose Alzheimer’s disease.
Clinical trials don’t always involve new drugs or medicines. They may consist of studies around caregivers, for example.Palliative treatment and improved quality of life for the chronically ill are other areas where clinical trials and clinical research can be of use.
How a clinical trial works
Clinical trial volunteers are carefully screened and fully informed about what they are consenting to. Trials often involve both a treatment group and a control group. The former is given the treatment on trial and the latter isn’t given anything. This is so that a full comparison can be made, and any effects caused by the circumstances or environment of the trial, rather than the actual treatment, can be identified.
All clinical trials in the US must be approved by the Food and Drug Administration (FDA) before they can go ahead. The FDA requires most trials to consist of three phases.Each phase involves testing the intervention on progressively larger groups of people.
Phase one might have 20–80 participants and be mainly concerned with establishing the safety of the intervention. If phase one determines that the treatment is safe, then a second trial (phase two) of 100–300 people might gather preliminary data on the treatment’s effectiveness for patients with a certain disease or condition. Safety is still carefully monitored.
Phase three trials might involve up to several thousand people from different backgrounds to compare effectiveness with existing treatment methods. If phase three is also successful, then the FDA will consider approving the treatment for general use. After this, a fourth phase of clinical testing may also take place, which studies long-term effectiveness on the general population.
Clinical trial nurses
Nurses rely on clinical trials to provide the scientific evidence that underpins their work. Trials are a crucial part of the research needed to develop the medicines, therapies, tools, and treatments that nurses use and administer every day. Clinical trials have a special relevance to nurses as these are where medical interventions are first tested on a range of people, to consider each person’s unique combination of age, race, sex, comorbidities, and other factors.
As nursing is first and foremost a patient-centered practice, how treatments affect individual patients is of particular concern to nurses. It is no surprise that nurses play an important part in conducting clinical trials as well. Their specific job title may vary, from clinical trials nurse to clinical research nurse, research coordinator, or other similar appellations. In all cases, they liaise between participants, including the research team, clinical and non-clinical staff, and the volunteer patients.
Taking care of patients
Having a capable clinical trials nurse on board will lead to increased enrolment in clinical trials, as volunteers feel safer, better informed, and more welcome in their care. Patient safety and confidentiality are among the primary concerns of a clinical trials nurse, alongside making sure that all trial protocols are rigidly adhered to. In addition to their medical training and experience, clinical trials nurses have the people skills and administrative ability to ensure clinical trials go smoothly.
Besides a specialist clinical trials nurse, research trials generally involve one or more staff nurses who attend to the immediate needs of the volunteer patients. This may involve administering medication, making clinical assessments, and collecting research samples. They are also on hand to monitor the patients and provide additional care as needed.
Staff nurses serve as patient advocates, placingthe volunteers’ interests ahead of the research project. They will ensure the volunteers are fully informed and consenting at every stage of the process and ensure that all paperwork is correct and up to date. They will also communicate with the volunteers’ families, making certain that they understand every aspect of what is happening or may happen in the future.
Anyone who is interested in becoming a registered nurse can qualify in just one year by taking an ABSN online at Wilkes University in Pennsylvania, following six prerequisite courses. This full-time accelerated Bachelor of Science in Nursing degree course is fully supported and requires just two weeks of campus residency, plus a clinical placement. With a huge demand for registered nurses across the US, this is the quickest and most effective way for individuals to begin the nursing journey.
Clinical trials require a multidisciplinary team that includes nurses in a variety of roles. Some examples are clinical research nurses, physician assistants, research assistants, regulating coordinators, biospecimen coordinators, pharmacy technicians, and nurse practitioners. Clinical research nursing involves coordinating care, careful project management, and patient protection.
There are subtle differences between the various nursing roles in a clinical trial. For instance, a clinical research nurse will focus on care for the volunteer patients while also coordinating the research activity. In contrast, a nurse researcher is part of a research team delivering new knowledge and information that will lead to long-term improvements in nursing practice, shaping health policy, and ultimately improving patient outcomes.
In a clinical trial, nurses may prepare and oversee all documentation, including setting out the trial protocols before testing commences and making sure that everyone is fully aware of these. They may submit study proposals for regulatory approval and later speak at conferences about the trial’s objectives and results.
During the trial itself, nurses may be responsible for making sure patient selection is random and for collecting and recording information. They will be reporting any adverse effects in volunteers promptly and taking full care of patients. Excellent communication and interpersonal skills are vital, as nurses may act as mentors, teachers, and advisors to other members of the research team, as well as being patient advocates.
Improving patient outcomes
In recent years, efforts have been made to streamline clinical trials to improve patient outcomes. The traditional three-phase method can sometimes take several years to complete, meaning that potentially life-saving treatments could be approved too late to help many of those who most need them.
In the field of cancer care, some nurses are using genome sequencing and molecular imaging technology to create a molecular profile of a patient’s tumor. These techniques allow nurses to quickly find the most beneficial treatment for cancer. Molecular profiling can divide common cancers into unique subtypes and, in combination with artificial intelligence (AI) systems, can be used to synthesize new drugs for rare cancers that are resistant to regular treatments.
With rare cancer types, the number of potential volunteer patients is obviously limited. Without compromising on safety or due diligence, clinical trials must be streamlined to work with fewer test subjects over a shorter period. Modern technology can be used to facilitate this.
Phases one and two can be combined so that the same group of patients are given a steadily increasing dose of the drug being tested until a safe but effective level is established. The next group is then immediately started on this dosage. Meanwhile, biometric sensors and patient-operated monitoring apps can combine to provide real-time information on patient health and progress. The resulting data can then be swiftly analyzed by AI programs.
One of the ways in which nurses may make use of clinical trials to improve patient outcomes is through evidence-based practice. Firstly, the evidence provided by trials may assist in preventative measures by promoting healthy lifestylesand stopping certain diseases from spreading, for instance, through vaccination.Secondly, trials can lead to new treatments that help with managing symptoms or ways to help patients manage their own symptoms. Thirdly, end-of-life care and palliative care can be improved. Clinical trials and research can also lead to new innovations and enable nurse scientists to progress in theircareers.
Clinical trials are essential in developing new treatment methods and testing out new approaches to disease prevention and patient care. Their role in establishing the safety of innovative interventions before they are rolled out to the general population is crucial to maintaining high standards of healthcare provision. Not only do nurses play a major part in administering clinical trials, but they also make use of the evidence provided in their general practice, working at all stages towards improved patient outcomes in specific cases and the overall population.
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