Clinical Trials : Clinical Trials Dr R S Nadig
What is a Clinical Trial : What is a Clinical Trial A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Why Participate in Clinical Trials : Why Participate in Clinical Trials Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research
Who can participate in Clinical Trials : Who can participate in Clinical Trials All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.
The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria".
These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Before joining a clinical trial, a participant must qualify for the study.
Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
It is important to note that inclusion and exclusion criteria are not used to reject people personally.
Instead, the criteria are used to identify appropriate participants and keep them safe.
The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a Clinical Trial : What happens during a Clinical Trial The clinical trial process depends on the kind of trial being conducted
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals.
They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition.
For all types of trials, the participant works with a research team.
Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What are the Different types of Clinical Trials : What are the Different types of Clinical Trials Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness
Different Phases of Clinical Trial : Different Phases of Clinical Trial Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test a 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 II 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 III 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.
What is Informed Consent : What is Informed Consent Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate.
It is also a continuing process throughout the study to provide information for participants.
To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
If the participant's native language is not English, translation assistance can be provided.
Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts.
Risks and potential benefits are explained in the informed consent document.
The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What is Protocol : What is Protocol A protocol is a study plan on which all clinical trials are based.
The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.
A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Benefits of Participating in Clinical Trials : Benefits of Participating in Clinical Trials Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
Play an active role in their own health care.
Gain access to new research treatments before they are widely available.
Obtain expert medical care at leading health care facilities during the trial.
Help others by contributing to medical research.
Risks of Participating in Clinical Trials : Risks of Participating in Clinical Trials There are risks to clinical trials:
There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
The experimental treatment may not be effective for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Protection of Safety of Participants : Protection of Safety of Participants The ethical and legal codes that govern medical practice also apply to clinical trials.
In addition, most clinical research is federally regulated with built in safeguards to protect the participants.
The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study.
As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.
Individual participants' names will remain secret and will not be mentioned in these reports