Archive for the ‘Clinical Trials Protocol’ Category

Why Monitor Clinical Trials for Adult Stem Cells

Wednesday, May 21st, 2008

There are many different stem cell clinical trials involving adult stem cells that are leading to life-saving results, and offering new alternatives to surgeries and drugs. With stem cell clinical trials, a cellular approach is used, which in many different studies has appeared to benefit patients in many new ways that were not available before. There are stringent minimum monitoring requirements in clinical trials studies to ensure patient safety, as well, so participants and researchers can feel secure about what they are doing.

Adult stem cell clinical trials do not involve embryonic stem cells that result in the destruction of an embryo; they involve adult stem cells that come from the patient’s own blood or bone marrow, or someone else’s. The transplant appears to be safe, and minimum monitoring requirements in clinical trials studies are in place to make sure of it. Many of these stem cell clinical trials have involved various cancers and multiple sclerosis. Stem cell clinical trials for liver disease have also recently started, and trials for cerebrovascular disease and spinal cord injuries are being considered.

Why monitor clinical trials involving adult stem cells so closely when the patients are using their own stem cells and not those of an embryo? Well, it is still vitally important to be sure that standard practices are followed so the results of the research are likely to be replicated in other patients if the treatment is introduced to the public. Stem cell clinical trials are still very new, and research must be monitored to ensure the safety for patients and the accuracy of results. With minimum monitoring requirements in clinical trials studies, patients and their families can be assured that the research will be as safe as possible. This is vitally important in the continuing support for this type of research, which has already been shown to save lives.

The Procedures Invloved in Clinical Trials

Tuesday, May 20th, 2008

Once clinical trials get under way, there are many steps that must be taken to ensure that they are in accordance with the requirements of the United States Food and Drug Administration. It is important to ensure that clinical research trials are as safe and thorough as possible, not only so that the patients who participate are taken care of, but also to be sure that the results are accurate. After collecting a great deal of information from clinical trials healthy volunteers over an extended period of time, such as vital signs, amount of the drug in their blood and whether their health gets better, the data is ready.

The data collected in clinical trials is sent to the study’s sponsor after the research is complete, at which point it is analyzed using a series of statistical tests that have been proven with time. Clinical research trials have a standard set of procedures, but the goals of these trials are not always the same. Clinical trials might be designed to assess the safety and effectiveness of a new medication or device on a specific kind of patient, or assess the safety and effectiveness of a different dose of a medication than is commonly used. Clinical research trials might also assess the safety and effectiveness of an already marketed medication or device for a new indication, or assess whether the new medication or device is more effective for the patient’s condition than the already used, standard medication or device.

In some cases, clinical trials are also used to compare the effectiveness in patients with a specific disease of two or more already approved or common interventions for that disease. Some clinical research trials even compare three or four medications, doses of medications, or devices against each other. In any case, the clinical trials healthy volunteers will be well aware of what the research trial will entail before they agree to participate.

Stem Cell Clinical Trials Protocol

Saturday, May 3rd, 2008

During stem cell clinical trials, there must be a sponsor to fund the lengthy and expensive research that is required for the effectiveness of the study. There are also stringent minimum monitoring requirements in clinical trials studies of this nature, which ensure the safety of the study and also make sure that they are within the letter of the law. Why monitor clinical trials you ask? Well, after reading further it should be clear to see why the standardized practices of monitoring are so important.

There are a variety of organizations that may sponsor stem cell clinical trials or any other type of clinical trials, including physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies. There are also federal agencies that sponsor stem cell clinical trials such as the National Institutes of Health. These agencies find the minimum monitoring requirements in clinical trials studies very important, because they do not want to be involved with a study gone wrong. Stem cell clinical trials can take place in a variety of locations and involve many different people who all want to ensure that the investigation is effective.

In addition to the minimum monitoring requirements in clinical research trials, there is also a study plan on which all clinical trials are based, which is known as a protocol. The study plan for stem cell clinical trials is carefully designed to safeguard the health of the participants, as well as answer specific research questions. With such a delicate subject as stem cells, it is easy to see why such a protocol should be followed.

Why monitor clinical trials? Well, it would be foolish not to have a monitoring system in place for such complex research that can affect the future of the medical; it is an important thing to do for the effectiveness of the trial research. And with a new subject area like stem cells, researchers want their trials to be monitored as closely as possible so their results are proven effective.

Different Types of Clinical Research Trials

Friday, March 21st, 2008

Clinical research trials are scientific investigations of new medical treatments, usually drugs, which have shown some benefit in animal or laboratory studies but have not yet been proven effective in humans. There are clinical trials healthy volunteers who agree to participate in these studies and have data collected about their reactions to the treatment, which they are often compensated for. There are a few different ways of classifying clinical research trials, since there are many different goals that researchers have when they conduct these studies.

It is possible to classify clinical trials by the way that the researchers behave when they are conducting the investigational study on the participants. Investigators might observe the clinical trials healthy volunteers and measure their outcome without actively managing the experiment, which is known as an observational study. Investigators might also give the clinical trials healthy volunteers a certain medicine or intervention, which is known as an interventional study. This is the kind of trial that people usually refer to when they are talking about investigational drugs.

A more thorough way of classifying clinical research trials is by their purpose, which there are five of according to the United States National Institutes of Health:

  1. Prevention Clinical Trials – Search for better ways to prevent diseases, with clinical trials healthy volunteers who have never had the disease, or try to prevent a disease from returning in patients who have recovered from it. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
  2. Screening Clinical Research Trials – Test the best ways to detect certain diseases or health conditions.
  3. Diagnostic Trials – Conducted to find better tests or procedures for diagnosing particular diseases or conditions.
  4. Treatment Trials – Test experimental treatments, new drug combinations or new approaches to surgeries or radiation therapies.
  5. Quality of Life Trials – Explore new methods of improving the comfort and quality of life for people with chronic illnesses.