Pharmaceutical Companies Sponsor Clinical Trials – Clinical trials are experiments or observations done in clinical research.
Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions. According to the National Institute of Health (NIH) research trials are used for many diseases and conditions, including cancer, Alzheimer’s disease, allergy and infectious diseases. Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions. Medical tests help with solving many observations of healthy individuals and their reactions to pharmaceutical drugs.
Depending on where you live you can have access to many facilities. The reason that these types of studies are important is because these trials provide information about the safety and efficacy of potential medicines, along with data about how they should be used and who can benefit from them. It has been reported that Clinical trials are research studies that evaluate new ways to improve treatments and quality of life with individuals with diseases. It is an option for all patients to consider and plays an important role in improving health care.
The results from clinical trials help develop new drugs, new diagnostic tools, and new clinical procedures. Interestingly clinical trials can also spur new questions for research, which lead to new discoveries over time and help us better understand diseases. You may be happy to know that all the drugs and tools we have today were made possible because patients volunteered for clinical trials. A clinical study involves research using human volunteers called participants that is intended to add to medical knowledge.
Understanding Eligibility Criteria – In every clinical trial there is what are called eligibility criteria. For example a patient may need to have a certain medical condition, or gender or other specifics. to meet the criteria of participating in the clinical trial. Otherwise they are not eligible for joining that clinical trial and could seek another trial that better fits their situation. Patients who want to volunteer need to understand the potential benefits and risks associated with participating in the clinical trial. Patients may benefit from receiving new therapies or procedures. They receive close supervision from clinical staff. Sometimes the cost of the new drugs or testing is free or waived.
Participants maybe also part of a research breakthrough – this what helps thousands of future patients. In some cases patients face the risk that they may not benefit from the new treatment but those that do must recognize the importance that participating in a clinical trial requires commitment this is because trials can be lengthy or demanding, and may require extra treatments, extra time in the clinic or test costs that are not part of standard care. It is standard that if the study is randomized that they may be part of a control group that does not receive the new drug being studied.
Informed consent is a process that helps patients to make an informed decision about whether to join a clinical trial. A informed consent document will be provided to explain the purpose, procedures, and potential benefits and risks of the trial. There will be discussions between the doctor and patient so that all questions can be clearly answered. In late stage clinical trials participants are generally split into 2 groups at the beginning of the study. There are two main types of clinical studies: interventional studies and observational studies.
One group receives the standard treatment plus the new treatment. This group is called the treatment group. The other group receives the standard treatment only and does not receive the new treatment. This group is known as the control group. A computer is used to randomly assign the patient to either the treatment group or teh control group. Randomization helps to prevent bias because neither the patient nor the doctor can choose which treatment group a patient is assigned to. Some clinical trials may want to study the effectiveness of adding a new treatment to a standard treatment to see what works better.
Textbook on clinical trials methodology
A placebo is a treatment that looks identical to the new treatment, but contains no active ingredient. These types of studies are often called blinded, meaning that one or more parties involved in the trial do not know which patient has been assigned to which treatment. Single blinded means that only one party either the researchers or the patients knows which patients have been assigned to which treatments. 
Double blinded means that both the researchers and the patients do not know which patients have been assigned to which treatment. The strongest and most reliable results come from clinical trials in which the treatment is double blinded. The patients are randomized and the study has a control group. and the study has a control group. This is called a double-blinded, randomized controlled clinical trial. Clinical trials are carefully monitored to protect patients, and several layers of review committees are involved to protect patients from any possible harm. Patients can leave a clinical trial at any stage. However they should discuss this with their doctor before exiting, to ensure the safest procedures are followed.
There are 4 different stages involved in clinical trials where safety is emphasized in each phase. If a trial does not have a positive or safe outcome in phase 1, then it will not be allowed to proceed to a phase 2 trial, and so on. Before a phase 1 trial begins, there is a phase 0, where the new treatment has already been found to be safe in animals or healthy human volunteers.
Phase 1 clinical trials a new treatment is tested in a small group of participants, for the first time to determine a safe dose. and to see how the treatment affects the body.
Phase 2 is conducted with a larger patient group than the previous phase and studies how well a new treatment or combination of treatments works for a certain type of cancer, like pancreatic cancer. At this stage the eligibility criteria become more restrictive. Phase 2 studies can be either randomized or non randomized.
Phase 3 trials are conducted in an even larger group of participants. This phase involves a randomized design, comparing a new treatment to a standard treatment. If a phase 3 clinical trial is positive, typically the new treatment will be approved and licensed for use in the united states by the food and drug administration or FDA. After the treatment has been approved Phase clinical trials involve monitoring to continue to assess safety, effectiveness, and optimal use.
Phase 4 includes new treatments which can include vaccines, drugs, dietary choices, dietary supplements, and medical devices. Clinical trials generate data on safety and efficacy and are conducted after health authority and ethics committee approval in the country where approval of the genetic therapy clinical trials is being used.
Clinical trials play a important role in moving science forward and can be a hopeful option for many patients with pancreatic cancer. To learn more about clinical trials and how to participate in one, please talk to your doctor. Clinical trials move science forward and can be a hopeful option for many patients.
Fundamentals of Clinical Trials 5th ed. 2015 Edition – This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. Considered by many as the gold standard reference on oncology clinical trials in the field, examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.Understanding How New Medications are Developed Through Research Trials
Reference:National Institutes of Health from the U.S. Department of Health and Human Services. NIH is the largest biomedical research agency in the world.
Wikipedia – en.wikipedia.org/wiki/Clinical_trial – Costs for clinical trials can range into the billions of dollars per approved drug. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Monitoring and lab work, is outsourced to a contract research organization or a central laboratory.
ClinicalTrials.gov – is a database of privately and publicly funded clinical studies conducted around the world.