when is it a Cell clinical study or clinical trial?

[peterf]

During a screening process for stem cell inc doctors avoided the word clinical trial and kept referring to the word clinical study.
I really do not like to use the word clinical trial especially when phase one is still in progress. I would call it a clinical trial in phase 3 or 4 but to most people a clinical study and a clinical trial mean the same thing but do they?

[GRAMMY]

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization or a clinical trials unit in the academic sector.

In planning a clinical trial, the sponsor or investigator first identifies the medication or device to be tested. Usually, one or more pilot experiments are conducted to gain insights for design of the clinical trial to follow. In medical jargon, effectiveness is how well a treatment works in practice and efficacy is how well it works in a clinical trial.

In coordination with a panel of expert investigators (usually physicians well known for their publications and clinical experience), the sponsor decides what to compare the new agent with (one or more existing treatments or a placebo), and what kind of patients might benefit from the medication or device. If the sponsor cannot obtain enough patients with this specific disease or condition at one location, then investigators at other locations who can obtain the same kind of patients to receive the treatment would be recruited into the study.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.

• Phase 1: Screening for safety
• Phase 2: Establishing the testing protocol
• Phase 3: Final testing
• Phase IV: 'Post-approval' studies

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.




http://en.wikipedia.org/wiki/Clinical_trial

[Wise Young]

During a screening process for stem cell inc doctors avoided the word clinical trial and kept referring to the word clinical study.
I really do not like to use the word clinical trial especially when phase one is still in progress. I would call it a clinical trial in phase 3 or 4 but to most people a clinical study and a clinical trial mean the same thing but do they?

peterf,

The National Institutes of Health defines clinical research as follows:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:
a. Mechanisms of human disease,
b. Therapeutic interventions,
c. Clinical trials, or
d. Development of new technologies.

2. Epidemiologic and behavioral studies

3. Outcomes research and health services research

Regarding clinical trials, NIH defined a clinical trial as:

a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)

Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:

Phase I clinical trials are done to test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g. determine a safe dosage range, and identify side effects).

Phase II clinical trials are done to study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.

Phase III studies are done to study the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

Phase IV studies are done after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Unfortunately, this definition does not rule out improper use of the term "clinical trials" to refer to illegal activities, such as non-approved administration of experimental therapies for payment. Here it is important to refer to the Good Clinical Practice (GCP) standards for clinical trials. GCP guidelines defines protection of human rights as a subject in clinical trials, how clinical trials should be conducted, the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. http://en.wikipedia.org/wiki/Good_Clinical_Practice

GCP varies from country to country. Incidentally, although GCP has been adopted into law by the European Union and China, it has not yet been adopted by the United States and is practiced only as guidelines for industry sponsored trials. Several aspects of the GCP guidelines, however, are common across all countries. These include:
1. prohibition of investigators and clinical trial sponsors to charge patients for experimental therapies although charging for approved therapies delivered during a clinical trial is all right if the charge is explicitly approved by the regulatory agency.
2. the investigator and clinical trial sponsors must adhere to a protocol and provide informed consent that is explicitly approved by the Institutional Review Board and the appropriate regulatory agency.
3. the investigator and clinical trial sponsors are responsible for any complications that arise in the clinical trial. In China, they are even stricter in that they require the clinical trial sponsors to carry insurance for the purpose of taking care of complications.

Several years ago, the NIH started a website called www.clinicaltrials.gov. Sponsors and investigators who are starting clinical trials must announce and provide details of the trial before it starts. Likewise, changes in the trials should be posted. Most legitimate clinical trials are announced on this site.

Wise.