Frequently Asked Questions

Purpose: Clinical trials are vital for evaluating new, investigational treatments or vaccines to determine their effectiveness and safety.

Impact on Daily Life: If you have ever taken a medicine or received a vaccine, you have already benefited from the crucial findings of clinical trials.

Key Objectives: These studies aim to answer specific health questions, such as:

• Does a new treatment have a meaningful impact?
• Is it more effective than existing treatments?
• Is it safe for people to use?

Investigational Nature: Treatments in clinical trials are referred to as "investigational" because they are still under evaluation and have not yet been approved by regulatory authorities.

Outcome: If trials show that a treatment is both safe and effective, it can receive approval for use by those who need it most.

Eligibility for Clinical Trials

General Requirements: Eligibility depends on specific criteria, such as age, gender, medical history, and the condition being studied. These criteria help ensure participant safety and the collection of reliable data.

Age and Participation Rules: Participants must generally be at least 18 years old, although medical eligibility requirements vary between studies. Volunteers can take part in only one trial at a time, with a gap of approximately three months between trials. After this period, you are free to apply for another study.

Medication Considerations: If you are currently taking medication, your eligibility will depend on the type of medication and the clinical study design, as these vary between trials.

Inclusion and Exclusion Criteria :

• Inclusion Criteria: Participants must meet specific requirements, such as having a particular medical condition, age, sex, body type, or treatment plan.
• Exclusion Criteria: Some trials have rules to prevent individuals from participating if their conditions might worsen during the study. These rules aim to ensure the safety of participants and the integrity of the results.

Why Criteria Matter: Inclusion and exclusion criteria are designed to help researchers obtain accurate data and ensure trials are conducted as safely as possible.

Other Types of Clinical Studies: Not all clinical trials test new treatments or vaccines. Some are "observational" studies, which collect information about participants' health during their regular care to help researchers better understand specific health issues.

Need Help? If you have questions about your eligibility, contact the recruitment team, who will be happy to help you find suitable studies.

Clinical trials involve certain risks; however, numerous precautions are in place to ensure the safety of participants. Volunteers receive thorough medical care and close monitoring throughout the study.

You can be confident that any newly identified risks, benefits, or side effects will be communicated promptly.

Benefits of Participating in Clinical Trials

• Access to Innovative Treatments: Participants may gain early access to cutting-edge therapies, medications, or medical devices that are not yet available to the public.
• Enhanced Health Monitoring: Clinical trials provide detailed and frequent health assessments, ensuring close monitoring of participants' conditions throughout the study.
• Proactive Role in Healthcare: Volunteers take an active role in their healthcare journey, exploring advanced treatment options and contributing to medical research.
• Financial Relief: Many trials cover medical expenses related to participation, reducing the financial burden for volunteers.
• Compensation Opportunities: Certain studies offer monetary compensation, which can be an additional incentive for participants.
• Contribution to Medical Advancements: Participants play a vital role in advancing medical science, helping researchers develop new treatments and improve healthcare for future generations.

Risks of Participating in Clinical Trials

• Uncertainty of Outcomes: As treatments are still in the testing phase, there is no guarantee of their effectiveness or success.
• Potential Side Effects: Participants may experience side effects or adverse reactions to the treatment being studied. Clinical trials aim to test new treatments thoroughly, but as they are still in development, there is a possibility of experiencing side effects. These side effects can vary depending on the medication or treatment being studied and may range from mild discomfort to more significant reactions.
  To safeguard participants, all known potential side effects are communicated clearly during the informed consent process. Additionally, trials are conducted under strict medical supervision, with participants regularly monitored to promptly address any adverse effects.
  The dosing of medicines is often adjusted gradually to minimise risks, allowing researchers to closely observe how participants respond. If unexpected side effects occur, medical teams are on hand to manage them and ensure participants’ safety.
  It’s important to recognise that side effects, while a potential risk, are closely controlled and monitored as part of ethical clinical trial practices, ensuring participant wellbeing remains a priority.
• Emotional Impact: The uncertainty and potential risks involved in trials can be emotionally challenging for some participants.Side effects in clinical trials extend beyond physical reactions, such as discomfort or adverse effects—they can also involve emotional and psychological challenges. The uncertainty surrounding treatment outcomes may provoke feelings of stress, frustration, or anxiety, especially for participants who are deeply hopeful for a cure.
  Researchers and medical teams recognise these risks and strive to offer comprehensive care that includes emotional and psychological support alongside physical monitoring. Open communication is encouraged throughout the trial to ensure that participants feel supported and any concerns are addressed promptly.
  Maintaining the overall wellbeing of participants both physical and mental is a fundamental priority during clinical trials.
• Time Commitment: Clinical trials often require significant time and effort, including frequent visits to research centres and adherence to study protocols.

Your safety during a clinical trial is ensured through rigorous protocols and ethical guidelines designed to protect participants at every stage. Here’s how:

1. Pre-Trial Safeguards

Ethical Approval: Every clinical trial must be reviewed and approved by an ethics committee to ensure it meets strict safety and ethical standards.

Thorough Testing: Treatments are extensively tested in laboratories and earlier trial phases before being administered to participants.

2. Informed Consent

Transparent Communication: Before joining a trial, you will be fully informed about the potential risks, benefits, and procedures involved.

Voluntary Participation: You have the right to withdraw from the trial at any time without any repercussions.

3. Ongoing Monitoring

Regular Health Assessments: Participants undergo frequent health checks to monitor their response to the treatment.

Safety Oversight Committees: Independent committees review trial data regularly and can halt the study if safety concerns arise.

4. Risk Management

Gradual Dosing: Treatments are often introduced in small doses to minimise risks and monitor side effects in a controlled manner.

Immediate Medical Support: Medical teams are on hand to address any adverse reactions or concerns promptly.

5. Privacy Protection

Confidentiality: Your personal and medical information is kept confidential and used only for research purposes.

These measures ensure that your wellbeing remains the top priority throughout the clinical trial process.

Informed consent is a fundamental process in clinical trials that ensures participants fully understand the study they are joining. It involves providing clear, detailed information about the trial, including its purpose, procedures, potential risks, benefits, and participant rights.

Key Elements of Informed Consent

• Comprehensive Information: Participants are given all relevant details about the trial, such as the treatment being tested, its potential side effects, and the expected duration of the study.
• Voluntary Agreement: Consent must be given freely, without any pressure or coercion, ensuring participants make an independent decision.
• Ongoing Process: Informed consent is not a one-time event. Participants are kept updated throughout the trial and can ask questions or withdraw at any time.

Why Is It Important?

• Protects Participant Rights: Informed consent ensures that individuals are aware of what they are agreeing to and can make an educated decision about their involvement.
• Promotes Transparency: It fosters trust between participants and researchers by clearly outlining expectations and responsibilities.
• Ensures Ethical Standards: The process upholds ethical guidelines, safeguarding participants' wellbeing and autonomy.

In essence, informed consent is a cornerstone of ethical research, prioritising the safety, rights, and understanding of every participant.

Compensation for participating in clinical trials varies depending on the study and its requirements. Typically, participants are compensated for their time, effort, and any inconvenience caused during the trial. This may include:

• Monetary Payment: Many trials offer financial compensation, which can range from a daily rate to a lump sum, depending on the complexity and duration of the study.
• Expense Reimbursement: Travel costs and other expenses incurred while attending the trial may be reimbursed.
• Additional Benefits: Some trials may provide free medical care or treatments as part of the study.

The exact details of compensation are usually outlined during the informed consent process, ensuring transparency and fairness.

Yes, you can leave a clinical trial at any point, even after it has started. Participation is entirely voluntary, and you are free to withdraw for any reason, whether during the application process, the trial itself, or even midway through the study.

If you decide to leave, it’s important to inform the research team so they can ensure your withdrawal is handled safely and responsibly. They may also discuss any potential implications for your health or the study’s results. Your decision to withdraw will not affect your future medical care or your eligibility for other trials.

During a clinical trial, participants go through a structured process designed to test the safety and effectiveness of new treatments, medications, or medical devices. Here's an overview of what typically happens:

1. Informed Consent

Before the trial begins, participants are provided with detailed information about the study, including its purpose, procedures, potential risks, and benefits. They must give their informed consent to participate voluntarily.

2. Screening and Eligibility

Participants undergo a screening process to determine if they meet the trial's inclusion criteria. This may involve medical history reviews, physical exams, or diagnostic tests to ensure they are suitable for the study.

3. Trial Participation

• Baseline Assessments: Initial measurements, such as blood tests or imaging, are taken to establish a starting point for comparison.
• Treatment or Intervention: Participants receive the treatment being studied, which could be a new medication, therapy, or device. Some may receive a placebo or standard treatment for comparison.
• Monitoring: Throughout the trial, participants are closely monitored for any changes in their health, side effects, or reactions to the treatment.

4. Data Collection

Researchers collect data at regular intervals to evaluate the treatment's effectiveness and safety. This may include physical exams, lab tests, or questionnaires about symptoms and quality of life.

5. Follow-Up and Aftercare

Once the trial concludes, participants may receive follow-up care to monitor any long-term effects of the treatment. Researchers analyse the collected data to determine the treatment's overall success and safety.

Clinical trials are conducted under strict ethical guidelines to ensure participant safety and the reliability of the results.

Yes, you can continue to see your primary healthcare provider while participating in a clinical trial. Clinical trials are designed to complement your existing care, not replace it.

Your primary healthcare provider can remain involved in your overall health management, and you are encouraged to keep them informed about your participation in the trial. This ensures that any treatments or medications prescribed during the trial align with your ongoing care plan.

If you have concerns about how the trial might affect your regular healthcare, the research team can provide guidance and work with your provider to address any potential conflicts.

A placebo is an inactive treatment or substance that mimics the appearance of the experimental medication but contains no therapeutic elements. Common examples include sugar pills or saline injections, depending on the trial’s format.

How Placebos Are Integrated into Studies

Clinical trials use placebos to establish a baseline for comparison, dividing participants into two groups:

• The Treatment Group: Receives the actual drug or intervention being tested.
• The Placebo Group: Receives the inert substitute designed to look identical to the real treatment.
• Monitoring: Throughout the trial, participants are closely monitored for any changes in their health, side effects, or reactions to the treatment.

In highly controlled trials, such as double-blind studies, neither the participants nor the researchers are informed about who is receiving the placebo or the active treatment. This approach prevents bias and helps ensure accurate results by isolating the true effects of the experimental treatment.

The Phenomenon of the Placebo Effect

Interestingly, individuals receiving a placebo sometimes exhibit improvement, even though the treatment lacks active ingredients. This response, known as the placebo effect, arises from the psychological impact of believing they are receiving treatment. However, it is not universal and varies from person to person.

Placebos are a vital component of clinical trials, helping researchers evaluate whether improvements stem from the actual treatment or psychological influences.

The duration of clinical trials can vary significantly depending on the phase of the trial and the complexity of the research. Here's a general breakdown:

Phase I

• Purpose: Focuses on safety, dosage, and side effects using a small group of healthy volunteers.
• Duration: Typically lasts several months.

Phase II

• Purpose: Tests the effectiveness of the treatment on a larger group of participants with the condition being studied.
• Duration: Can last from several months to up to two years.

Phase III

• Purpose: Involves hundreds or thousands of participants to confirm effectiveness, monitor side effects, and compare the treatment to existing options.
• Duration: Often spans one to four years.

Phase IV

• Purpose: Conducted after regulatory approval to monitor long-term effects and safety in a larger population.
• Duration: May continue for several years.

Although clinical trials can span several years in total, individual participants are usually involved for only a portion of the study's duration. This depends on the specific phase of the trial, the participant’s enrolment timing, and the requirements of the research.

In clinical trials, the treatments or interventions you might receive depend on the study's purpose and design. Here are some common types:

1. Experimental Treatments

• New Medications: These could be drugs that are not yet available to the public and are being tested for safety and effectiveness.
• Medical Devices: Trials may involve innovative devices, such as implants or diagnostic tools, to assess their functionality and benefits.

2. Standard Treatments

• Existing Therapies: In some trials, participants receive standard treatments already in use to compare their effectiveness against new interventions.

3. Placebos

• Inactive Substances: In certain trials, participants may receive a placebo, which is designed to look like the treatment but contains no active ingredients. This helps researchers measure the true effect of the experimental treatment.

4. Lifestyle or Behavioural Interventions

• Dietary Changes: Some studies focus on the impact of specific diets or nutritional plans.
• Exercise Regimens: Trials may test the benefits of physical activity on health conditions.
• Psychological Therapies: These could include counselling or cognitive behavioural therapy to address mental health or behavioural issues.

5. Preventative Interventions

• Vaccines: Trials may test new vaccines to prevent diseases.
• Screening Methods: Studies might evaluate new ways to detect conditions early.

The specific intervention you receive will depend on the trial's goals and the group you are assigned to.

Eligibility for a clinical trial is determined by specific criteria set by the researchers, known as eligibility criteria. These criteria ensure that participants are suitable for the study and help maintain the reliability of the results. Here’s how you can determine if you qualify:

1. Entry Conditions

Researchers outline clear entry conditions in the trial protocol. These may include:

• Type of Condition: Trials often focus on specific diseases or conditions, so your diagnosis must align with the study’s focus.
• Stage of Condition: Some trials require participants to be at a particular stage of their illness.
• Previous Treatments: You may need to have undergone certain treatments or avoided others to qualify.

2. General Health and Demographics

• Age Range: Trials may specify age limits, such as adult-only studies or those tailored for older individuals.
• Overall Health: Your general health and fitness level are assessed to ensure you can safely participate.
• Other Medical Conditions: Researchers may exclude participants with certain conditions that could interfere with the study.

3. Screening Process

Before joining, you’ll undergo a screening process that may involve:

• Medical history reviews
• Physical examinations
• Diagnostic tests

4. Consultation with Your Doctor

• Your healthcare provider can help determine if a trial is suitable for you based on your medical records and overall health.

If you experience side effects or adverse reactions during a clinical trial, the research team will take immediate steps to ensure your safety and wellbeing. Here's what typically happens:

1. Reporting the Side Effects

• You are encouraged to report any symptoms or concerns to the research team as soon as they occur.
• The team will document the side effects in detail, including their severity, duration, and potential connection to the treatment.

2. Medical Assessment

• A thorough medical evaluation will be conducted to understand the nature of the side effects.
• If necessary, additional tests or examinations may be performed to determine the cause and severity of the reaction.

3. Adjustments to Treatment

• Depending on the severity of the side effects, the treatment may be adjusted, paused, or stopped altogether.
• In some cases, you may be withdrawn from the trial to prioritise your health and safety.

4. Access to Medical Care

• You will receive appropriate medical care to manage the side effects, whether through medication, therapy, or other interventions.
• The research team will ensure you are supported throughout the process.

5. Ethical Oversight

• An independent safety monitoring board regularly reviews trial data to identify and address any safety concerns.
• If the side effects are deemed significant, the trial may be modified or halted to protect participants.

Your safety is the top priority in any clinical trial, and measures are in place to respond promptly and effectively to any adverse reactions.

Contact nearby hospitals or research institutions, as many conduct clinical trials and can provide information on ongoing studies.

Speak to your healthcare provider, who may know of trials relevant to your condition.