As an ophthalmology resident or early career surgeon, it is important to be involved in Ophthalmology Clinical Trials opportunities. But how can you nurture these opportunities in the clinic? This article will guide you through definitions and tips for introducing clinical research to your patients.
Being an ophthalmologist is an incredible privilege
Being able to provide vision to patients while improving their quality of life is nothing short of amazing. Both the fields of ophthalmology and optometry have seen exponential technological, surgical and medical growth over time, and we have been privileged to share this with our patients.
In keeping with the innovation and learning of new techniques, drugs and devices available to our patients, it is essential to recognize the importance of the years of clinical research and development behind each of these advances. As a huge personal passion, clinical research in ophthalmology is a large part of my practice and in some cases has brought new technologies to our patients even before FDA approval.
This article focuses on the benefits of clinical research in training and practice, as well as how best to communicate the idea of participating in a clinical trial in patient communication.
Deciding to be part of a clinical trial – from a doctor’s perspective
Incorporating clinical Ophthalmology Clinical Trials into practice is a personal decision. For those who don’t like research, you shouldn’t force it. The very act of organizing research trials and managing administrative tasks is a labor of love – and for those of us who do it (and do it every day), we understand the necessity of the (many) extra hours required to complete an exam.
Building a research team is important: an organized support network in your office or clinic will help bring success and make these new therapies a reality for your patients. The team may consist of, among others, a physician (principal investigator), clinical research coordinator(s), research technicians. It is important to understand the benefits of participating in clinical research, which can be shared with your colleagues and staff in many ways. Innovation in science and medicine is exciting—and for the most part, the people involved are just as excited to be part of what moves science forward. This positive environment surrounding clinical research is a key aspect of what will enable successful enrollment in clinical trials.
Moreover, it’s important to consider what patients’ perspectives are on clinical research to help your patients understand. Whether participating in a trial is right for them.
Deciding to be part of a clinical trial – from the patient’s perspective
There are several key points to consider when introducing clinical research to your patients (and in order to create a successful registration). Each trial has benefits and risks; all questions should be answered before participating in the study.1-4 Patients should be encouraged to take notes or bring a friend or relative with them to remember the answers and come up with additional questions.1-4 Patients should be briefed on key questions exam elements that include:
Research study protocol:
It is imperative to check the type of study you are doing. Patients in an observational study (without active treatment intervention) may be more suitable for inclusion than a prospective interventional study. The overall study protocol, including the study design (eg, randomized vs. nonrandomized), should be discussed so that patients understand how the study will work and the possibility that they may receive the experimental treatment or a placebo under certain circumstances. In addition, it is sometimes helpful briefly review the stages that research studies go through so that potential subjects can better understand what “Ophthalmology Clinical Trials” they are in and the risks involved.
Prior to clinical trials, basic science research is conducted to increase understanding of normal human biology and disease in order to ultimately discover and develop new therapies to improve health.4,7 Testing at this stage is typically performed in the laboratory on cells/tissues and possibly on animals. Once a new treatment appears to be safe, has therapeutic potential, and also has a low risk of side effects, it can move into various phases of clinical trials.
Phases of clinical trials:
It usually takes years for a new drug or device to go through clinical trials and gain market approval!
- Phase 0 (Exploratory/Pilot): This phase involves a small number (~10-15) of participants to test response to a small (subtherapeutic) dose of drug/early device use and examine diagnostic test results.
- Phase I (Safety): This phase involves a slightly larger number of subjects (~20-100) and serves as the first phase of testing the respective therapy in healthy patients to establish the drug’s safe therapeutic dose range / best use. new device and identify possible side effects.
- Phase II (Proof of concept): This phase usually involves a much larger number of subjects (hundreds) to assess the effectiveness of the treatment and further identify any safety issues.
Next Steps
- Phase III (regulatory): This phase of the clinical trial involves hundreds to thousands of participants to confirm clinical benefits and safety risks. During this time, investigators may also compare the experimental treatment with another treatment (eg, something already on the market as standard of care or non-interventional standard of care).
- Phase IV (post-market surveillance): These studies use large populations for marketing and safety surveillance of a now-approved treatment to monitor efficacy, safety, and long-term effects, as well as to compare the approved treatment with others and confirm where it is best used.
- Completion of the trial (at any stage): At the end of the study, researchers carefully review the data collected during the study before making a decision about the significance of the Ophthalmology Clinical Trials findings and the need for further testing. After a phase I or II study, researchers decide whether to move on to the next phase or stop testing because of safety or efficacy issues. After phase III studies, researchers carefully analyze the data and decide whether the results have real medical significance. The results are often published in peer-reviewed scientific journals; if it is particularly important, the results can be discussed at scientific meetings.1-4 Ultimately, once a new therapy is proven safe and effective in a clinical trial, it can become the new standard of medical care!
Types of clinical trials:
Studies may have different designs to ensure they produce the best and most informative results. Potential subjects have the right to know the type of study, as this may also influence the decision to enroll.
- Controlled study: This type of study involves 2 or more groups of participants, one with the investigational therapy (experimental group) and one with a comparison (or placebo) treatment (control group). This type of study is important because it allows comparisons between the two groups. The placebo used in the control group usually appears identical to the study treatment (eg, sugar pill, saline eye drops) – this helps determine whether the study effects are related to the actual biochemical/physical properties of the treatment vs. psychological effects (ie the “placebo effect”).3-7
- Blinded study: In a blinded study, patients do not know what treatment they are receiving until the study is completed.4-6 Blinding ensures that the results are not biased by the subjects’ or investigators’ assumptions (ie, what they think the outcome will be if they know the treatment each received Subject). A study is double-blind if the researchers also do not know what treatment the patients are receiving (this is usually recorded by another member of the research team).
Randomized study:
This means that each person in the study is randomly assigned to either the treatment group or the control group being studied.4-6 Randomization helps reduce the chance that patients in one group will be so different from the other that it could affect the results; it also helps to ensure that the groups have patients in a similar state of health, so the results are not biased. Patients in randomized trials cannot choose which group they belong to – this needs to be made very clear during the informed consent process.
- Cross-over study: In a crossover design, all participants can experience both the new treatment and the control/comparison treatment. This works by having the subjects switch groups after a period of time using the new treatment, the new device, or if they are in the control group .3-7 There is usually a “washout” period during which participants stop taking their assigned treatment or control for a period of time to “wash out” any lingering effects before changing therapy. Cross-examinations are usually longer. However, the advantage of cross-over studies is that the patients become their “own controls”, allowing better treatment-control comparisons and better data analysis.
- Observational studies: Observational studies do not involve any active research treatment or control group, but follow the outcomes of patients with certain conditions or taking specific medications over time.
Time spent participating in the trial version:
Trials usually last at least a few weeks to several years. Reviewing the timeline of trials and necessary visits can help the patient decide if enrollment is feasible-they need to think about transportation, work schedules, and whether the visits can fit into their lives.
Registration risks:
All clinical trials have risks (it can also be argued. That there are risks associated with any medical test. Procedure or treatment). The risk may be higher in a clinical trial, especially with a new drug. Or investigational use of a new device, because there are more unknowns. It is important to explore this thoroughly with patients and also to ensure that all precautions are taken to ensure a safe clinical trial, in some cases under Vial and/or FDA oversight.
Confidentiality:
One concern patients may have when enrolling in a study is whether or not their protect health information. And/or identity will keep confidential. In general, patients should reassure that information need for the study is share only with. The research team. In fact, most patients are assign a research ID or “code” that is then use throughout the study. And for data analysis for additional protection their PHI. In the rare event of a Ophthalmology Clinical Trial-related adverse event or complication. It may be necessary to provide personal information to the research team. IRB, or FDA to best understand and treat the above event.
Cost:
Patients often ask if participating in a study will cost money. In most cases, the study sponsor (eg, pharmaceutical company. University/institution, government agency) will provide the treatment free of charge and may. Pay for any special tests related to the study. Including visits. Some sponsors may pay more (eg, travel time, kilometers etc.). In the US, the Affordable Care Act (ACA) requires health insurance to cover routine costs. And care for people who are in approve clinical trials. Of course, every trial course and sponsorship is different; this clear with potential subjects.
Informed consent must be clear and permanent:
As a potential investigator, you must be aware that informed consent is a dynamic and ongoing process. In addition to the initial inform consent process, which documents the risks and benefits of study participation. All changes to the study is communicate to actively enroll participants. Research subjects must inform of any changes in the study. This can include anything from information about early termination of the study due to adverse effects. Newly discovere beneficial therapeutic effects of the study item. As well as new forms of data collection that may affect the number of study visits. Another important aspect of a clinical trial is that participation is completely voluntary. And that patients can leave the study at any time without affecting their current standard medical care.
Ensuring that patients feel safe:
Even after consent review and successful study enrollment, patients will still need to protect throughout the study and treatment. Another important aspect of clinical research that needs to consider with patients. Is the fact that that clinical trials are strictly regulat and must conduct in. Accordance with standard ethical guidelines. Codes of conduct and national laws to ensure patient safety. Protection of human rights and privacy, good clinical practice, responsible research conduct. And quality data collection. All studies. Whether for new or establish treatments, must approve by an Institutional Review Board (IRB). The IRB consists of physicians, researchers, lawyers, and other members of the community. The potential benefits of the study. Once the study is approve. the IRB will continue to monitor the study.
Meeting the research team:
Another aspect of making sure patients feel safe. during study enrollment is knowing. Who the research team is and identifying the members who will care for them.
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