Frequently Asked Questions

A clinical trial is a carefully designed research study that evaluates the safety and effectiveness of new medical interventions, such as drugs, devices, or treatments. These studies involve human volunteers and are essential for advancing medical knowledge and improving patient care. Clinical trials help researchers understand how interventions work in humans, identify side effects, determine optimal dosages, and ultimately bring new therapies to patients.

Clinical trials are crucial for developing new treatments, improving existing ones, and advancing medical knowledge. They provide evidence-based data on the safety and efficacy of medical interventions, which is essential for regulatory approval and clinical practice. Additionally, clinical trials offer patients access to potentially beneficial treatments before they're widely available and contribute to the overall improvement of healthcare.

Clinical trials typically have four phases:

• Phase I: Tests safety and side effects in a small group of healthy volunteers or patients.
• Phase II: Evaluates effectiveness and further assesses safety in a larger group of patients with the condition.
• Phase III: Compares the new treatment to standard treatments in even larger groups, often across multiple centers.
• Phase IV: Monitors long-term effects and rare side effects after the treatment is approved and in use by the general public.

Participants are selected based on specific criteria, known as inclusion and exclusion criteria. These may include age, gender, type and stage of a disease, previous treatment history, and other medical conditions. The criteria ensure that the trial results are reliable and applicable to a specific patient population. Researchers carefully screen potential participants to determine their eligibility and to ensure the safety of all involved.

Informed consent is a crucial ethical and legal process where potential participants are given detailed information about the trial, including its purpose, procedures, risks, and potential benefits. This information is typically provided both verbally and in writing. Participants must voluntarily agree to take part and can withdraw at any time. The process ensures that participants fully understand what the trial involves before deciding to participate, protecting their rights and safety.

Benefits of participating in a clinical trial may include:

• Access to new treatments before they're widely available
• Expert medical care and close monitoring
• Playing an active role in one's own health care
• Contributing to medical research that may help others in the future
• Potential improvement in one's condition
• Gaining a deeper understanding of one's health condition
• Possible compensation for time and travel expenses

Potential risks of participating in a clinical trial include:

• Side effects from the treatment, which can range from mild to severe
• The possibility that the treatment may not be effective
• The treatment may be less effective than existing treatments
• Participation may require more time, tests, and medical visits than standard care
• Possible discomfort from medical tests or procedures
• Unforeseen risks or complications
• The possibility of receiving a placebo instead of the active treatment in some trials

Clinical trials can be sponsored by various entities, including:

• Pharmaceutical companies
• Biotechnology companies
• Medical device companies
• Academic medical centers and universities
• Government agencies (like the National Institutes of Health)
• Non-profit organizations and foundations
• Individual researchers or physician-investigators

The sponsor is responsible for funding, designing, and overseeing the conduct of the trial, as well as analyzing and reporting the results.

The duration of clinical trials can vary greatly, ranging from a few weeks to several years. Factors affecting the length include:

• The type of treatment being studied
• The condition being treated
• The phase of the trial
• The specific goals of the study
• The number of participants required
• The time needed to observe effects or outcomes
• Regulatory requirements

Some trials may involve long-term follow-up periods to assess long-term effects and outcomes.

A placebo is an inactive substance that looks like the treatment being tested but has no known medical effects. Placebos are used in clinical trials to:

• Compare the effects of the new treatment against no treatment
• Help determine if the new treatment is truly effective or if improvements are due to other factors
• Assess the true side effect profile of the new treatment
• Control for the psychological effects of receiving treatment
• Eliminate bias in the study results
• Meet regulatory requirements for drug approval

Placebo-controlled trials are considered the gold standard for evaluating new treatments.

In a double-blind study, neither the participants nor the researchers directly involved in conducting the study know who is receiving the experimental treatment and who is receiving a placebo or standard treatment. This design helps:

• Prevent bias in the study results
• Eliminate the potential influence of participants' or researchers' expectations on the outcomes
• Ensure that any observed effects are due to the treatment itself
• Increase the reliability and validity of the study findings
• Meet regulatory standards for high-quality clinical research

Participant safety and rights are protected through several measures:

• Ethical review boards (IRBs or Ethics Committees) that approve and monitor the trial
• Informed consent processes
• Ongoing monitoring of the trial by safety committees
• The ability of participants to withdraw at any time
• Strict regulatory guidelines and oversight
• Good Clinical Practice (GCP) standards
• Data safety monitoring boards for larger trials
• Transparent reporting of adverse events
• Protection of participant privacy and confidentiality

After a clinical trial is completed:

• The data is collected, verified, and analyzed
• Results are interpreted to determine the effectiveness and safety of the treatment
• Findings are typically published in peer-reviewed medical journals
• Results may be presented at scientific meetings and conferences
• If the treatment proves safe and effective, it may move forward in the approval process for wider use
• The sponsor submits the results to regulatory agencies for review
• Participants are often informed of the study outcomes
• The results are usually made publicly available on clinical trial registries

You can find suitable clinical trials through various resources:

• Your healthcare provider or specialist
• Patient advocacy groups and disease-specific organizations
• Online databases like ClinicalTrials.gov
• MedPath Search, which provides a comprehensive search tool
• Hospital and academic medical center websites
• Pharmaceutical company websites
• Local research centers and universities
• Clinical trial matching services

When searching, consider factors like your condition, location, and specific eligibility criteria to find the most relevant trials.

Eligibility for clinical trials varies depending on the study. Criteria may include:

• Age
• Gender
• Type and stage of a disease
• Previous treatment history
• Other medical conditions
• Genetic factors
• Lifestyle factors

Some trials seek participants with specific conditions, while others need healthy volunteers. It's important to carefully review the eligibility criteria for each trial you're interested in.

Before participating in a clinical trial, consider:

• The potential risks and benefits
• Your current health status and treatment options
• The time commitment required
• The location of the trial and travel requirements
• Potential costs and whether they're covered
• The impact on your daily life and work
• Your support system
• The qualifications and experience of the research team
• The purpose and design of the study
• Your personal goals and motivations for participating

Important questions to ask include:

• What is the purpose of the study?
• What treatments or procedures will I undergo?
• What are the potential risks and benefits?
• How long will the trial last?
• How often will I need to visit the study site?
• Will I be reimbursed for expenses?
• What happens if I want to leave the trial?
• How will my privacy be protected?
• Will I receive the results of the trial?
• What happens after the trial ends?

Your safety during a clinical trial is ensured through:

• Careful screening before participation
• Regular monitoring of your health throughout the trial
• Immediate reporting and management of any side effects
• Oversight by ethics committees and regulatory bodies
• The ability to withdraw at any time
• Adherence to strict protocols and safety standards
• Ongoing review of data by safety monitoring boards
• Prompt communication of any new safety information
• Access to medical care and support throughout the trial

Treatment trials and prevention trials differ in their goals and target populations:

• Treatment trials:
  • Test new treatments for people who already have a specific condition
  • Aim to find better ways to treat or manage a disease
  • Participants usually have the condition being studied
• Prevention trials:
  • Test new approaches to prevent a disease from occurring or recurring
  • Can include medicines, vitamins, vaccines, or lifestyle changes
  • Often involve healthy participants or those at high risk for a condition
  • May also include people who have had a condition and want to prevent recurrence

Yes, you can usually continue seeing your regular doctor during a clinical trial. In fact, it's often encouraged:

• Your regular doctor can provide valuable input and continuity of care
• You should inform your doctor about your participation in the trial
• The trial team may communicate with your doctor about your care
• Your regular doctor can help monitor for any changes in your health
• You may need to coordinate between your regular care and trial-related care
• Some trials may require you to avoid certain treatments or medications
• Always inform both your trial team and regular doctor about any health changes or concerns

A clinical trial protocol is a detailed plan that guides how the study will be conducted. It includes:

• The objective of the study
• The design and methodology
• Participant selection criteria
• The schedule of tests, procedures, and medications
• The length of the study
• Information to be gathered
• Safety precautions
• How data will be reviewed and analyzed
• Ethical considerations and informed consent procedures
• The protocol ensures that all researchers conduct the study in the same way, regardless of location.

The placebo effect is a phenomenon where a person experiences a benefit after receiving a 'treatment' with no known medical benefits. In clinical trials:

• It can cause improvements in participants receiving an inactive treatment
• It's one reason why controlled trials are necessary to prove a treatment's effectiveness
• Researchers must account for the placebo effect when analyzing results
• It demonstrates the power of the mind-body connection in healing
• The strength of the placebo effect can vary depending on the condition and the individual
• Understanding the placebo effect helps in designing more rigorous trials
• It's not considered a 'fake' effect, but a real psychological and sometimes physiological response

If you experience side effects during a clinical trial:

• Report them immediately to the research team
• The team will assess the severity and relation to the study treatment
• You may receive medical care to manage the side effects
• The study protocol may be adjusted if necessary
• In severe cases, you may be advised to discontinue the treatment
• All side effects are documented and analyzed as part of the study results
• The safety monitoring board may review serious side effects
• You have the right to withdraw from the study if you're concerned about side effects
• Follow-up care may be provided even after you leave the study

The effectiveness of a new treatment in a clinical trial is determined through:

• Comparison with a control group (placebo or standard treatment)
• Measuring predefined outcomes or 'endpoints'
• Statistical analysis of the data collected
• Assessment of clinical significance, not just statistical significance
• Evaluation of the balance between benefits and risks
• Long-term follow-up in some cases
• Replication of results in multiple trials
• Review by independent experts and regulatory agencies
• Consideration of quality of life improvements
• Assessment of cost-effectiveness in some cases

To find relevant trials, enter keywords related to a condition, treatment, or drug in our search bar. You can refine your results using our advanced filters, including location, trial phase, and eligibility criteria.

We update our database daily to include new trials and reflect changes in existing ones. However, always verify the most current information with the trial coordinators directly.

Yes, you can use our location filter to search for trials in specific countries, states, or cities.

When you subscribe to a trial, you'll receive email notifications about any updates or changes to that trial, helping you stay informed about its progress.

Yes, MedPath Search currently offers free access to our core search functions and trial information. We may introduce premium features in the future, but we'll always maintain a free tier for basic access.

You can search for trials without an account, but you'll need to create one to use features like trial subscriptions and saving searches.

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You can view and manage your subscriptions in your account settings. From there, you can add or remove trial subscriptions as needed.

Currently, there is no limit to the number of trials you can subscribe to with a free account.