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What is Clinical Trials
Medical studies that are conducted to search for cures of various medical symptoms and diseases are called Clinical Trials. Clinical trials involve subjects participating in these research studies. Clinical trials look at
- Preventing disease - using drugs, vitamins, foods to reduce risk
- Treatments - new drugs or combinations of drugs; new ways of giving treatment, new types of treatment
- Diagnosing disease - new tests or scans
- Controlling symptoms - new drugs or complementary therapies
- A Clinical study is conducted to determine:
- Safety and efficacy of a new drug
- Safety and efficacy of a different dose of drug
- Safety and efficacy of an already marketed drug to treat a different indication/symptom
- Whether Device A is better at treating a patient versus Device B
- Clinical trials can be classified based on their purpose. The U.S National Institute of Health organized trials in to 5 different categories:
- Prevention Trials: Looks for better way to prevent disease in people who have never had the disease or to prevent the disease from returning.
- Screening Trials: Test the best way to detect certain diseases or health conditions.
- Diagnostic Trials: Conducted to find better tests or procedures for diagnosing a particular disease or medical condition.
- Treatment Trials: Test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Quality of Life Trials: Explore ways to improve comfort and quality of life for patients with chronic illness
- Phase I studies assess the safety of a drug or device. This primary stage of testing usually includes a small number of healthy volunteers (20 to 100), who are generally compensated for participation in the study. This stage can take months to complete sometimes. The study is constructed to determine the effects of the drug or device on humans including how it is consumed, metabolized, and discharged. This stage also explores the side effects that occur as dosage levels are deviated. About 70% of experimental drugs pass in this is stage of testing.
- Phase II studies test the productivity of a drug or device. This second stage of testing can last from several months to two years, and involves up to several hundred patients. Most studies of this stage are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Neither the patients nor the researchers know who has received the experimental drug because these studies are often blinded. This allows investigators to support the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
- Phase III studies involve randomized and blind testing in numbers from 100 to 1000. This large-scale stage of testing, supplies the pharmaceutical company and the FDA with a more absolute explanation of the performance of the drug or device, the benefits and the extent of possible adverse reactions. In this stage of testing 70% to 90% of drugs that enter successfully complete this phase of testing. Once this stage is complete, a pharmaceutical company can request FDA approval for marketing the drug.
- Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage:
- To analyze drug with other drugs already in the market;
- To supervise a drug's long-term productivity and impact on a patient's quality of life; and
- To conclude the cost-effectiveness of a drug therapy relative to other traditional and new therapies.
- This stage studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
How Do I Know It is Safe?
Treatments and drugs are thoroughly tested in the laboratories before they are ready for tests with human patients. The treatment/drug goes through the three phases of clinical trial before they can be marketed on a global scale. All clinical trials are conducted by board certified and well experienced physicians and specialists. Patient safety is always the highest priority on any given study agenda.
There are many other safeguards for patients taking part in trials
- The trial plan (protocol) is inspected and must be approved by an ethics committee
- The running of the trial is supervised by a data monitoring committee (During the Trial)
- Your privacy is protected
- You must be told all about the benefits and risks before you agree to take part
- Questions you may want to ask before participating in a clinical trial.
- Why is this trial being conducted?
- What are the advantages and risks of taking part in a clinical trial?
- What are the treatment choices in the trial?
- What are the likely side effects of a particular trial?
- How many patients are being studied?
- How long will the study last?
- Can I drop out / withdraw my consent at any given time?
- Who will be allowed to view my medical history and records?
- Who will be informed of my trial participation?
- What are my responsibilities as a participant?
- Who should I contact in case of an emergency?
- Who makes sure that the trial is safe and properly run?
- What treatment do I get if I participate in a trial?
- Will I have to spend time in hospitals or having tests?
- Is there anything I’m not allowed to do while participating in a trial?
- Will I be reimbursed for my time and travel?
- Am I covered by insurance if things were to go wrong?