Clinical trials are a vital part of the drug development process, helping determine the safety, efficacy, and long-term effects of new therapies. Yet, many questions surround how they work, who conducts them, why they take time, and how participants are involved. This FAQ page addresses the most common questions people ask about clinical trials, from their purpose and phases to safety, ethics, and how to participate. Whether you’re a potential volunteer, healthcare professional, or someone seeking a better understanding of the clinical research process, these answers are designed to offer this information.
Explore the answers to high-interest queries like:
- Why are clinical trials important?
- Are clinical trials safe?
- How are clinical trials conducted?
- What do different clinical trial phases mean?
- Can clinical trials help treat disease?
This guide is intended to improve understanding of the clinical research process.
What is a Clinical Trial? What are clinical trials? What do clinical trials mean? What are clinical trials for? What do clinical trials do?
Clinical trials are scientifically designed research studies conducted in human volunteers to evaluate the safety, efficacy, dosage, and side effects of medical interventions such as drugs, vaccines, biologics, devices, or treatment approaches. They play a critical role in advancing medical knowledge, supporting regulatory submissions, and guiding clinical decision-making. Clinical trials are conducted in sequential phases under strict ethical oversight, and their results determine whether a product can be approved for public use. These trials also help identify which treatments work best for specific patient populations, compare new interventions to current standards of care, and generate real-world evidence to inform long-term outcomes.
Why are clinical trials important?
They generate scientific evidence to evaluate the safety and effectiveness of new treatments before regulatory approval and public use.
Why are clinical trials conducted?
To test new drugs, devices, or interventions in humans under controlled and monitored conditions to assess safety, efficacy, and appropriate dosage.
Why are clinical trials necessary?
They are essential for regulatory submission and are required to establish whether a new treatment works and is safe for patients.
Why do clinical trials stop?
Trials may stop early due to safety concerns, insufficient efficacy, poor enrollment, or sponsor-related decisions.
Why do clinical trials fail?
Common reasons include lack of therapeutic benefit, unexpected adverse events, protocol deviations, or operational issues.
Why do clinical trials matter?
They are the foundation of evidence-based medicine and contribute to improved standards of care.
Why do clinical trials take so long?
Multiple phases, patient recruitment, regulatory processes, data collection, and safety follow-up require time to ensure validity and compliance.
Why are clinical trials ethical?
They follow international guidelines like ICH-GCP and require independent ethics committee approval to protect participants’ rights and safety.
Why are clinical trials needed?
To provide the clinical evidence required by regulators for drug approval and to advance medical knowledge.
Why is there mystery around clinical trials?
Clinical trials often involve complex protocols, confidentiality agreements, and limited public visibility, leading to misunderstandings.
Which phase of clinical trials tests drug efficacy?
Efficacy is assessed primarily in Phase II and confirmed in Phase III trials.
Which phase of clinical trials?
- Phase I: Safety and dosage
- Phase II: Efficacy and side effects
- Phase III: Comparison and confirmation
- Phase IV: Post-marketing safety and real-world use
Are clinical trials worth it?
Yes. They are a critical step in bringing new therapies to market and may offer benefits to participants under close medical supervision.
Are clinical trials dangerous?
All clinical trials involve risk, especially early-phase studies. However, protocols include safety monitoring to minimize harm.
Are clinical trials safe?
They are designed with participant safety as a priority and are monitored throughout by investigators and ethics committees.
Are clinical trials paid?
Many trials offer compensation for time, travel, and inconvenience, depending on the phase and country regulations.
Are clinical trials for everyone?
No. Participation depends on specific eligibility criteria related to age, diagnosis, medical history, and other factors.
Are clinical trials ethical?
Yes. They are conducted under ethical guidelines and require informed consent, regulatory approval, and ongoing oversight.
Are clinical trials effective?
They are designed to test the effectiveness of treatments, but not all investigational therapies prove beneficial.
Are clinical trials necessary?
Yes. They are legally required for new drug approvals and essential for evaluating medical innovation.
Are clinical trials legitimate?
Trials conducted under regulatory and ethical supervision by authorized sponsors and investigators are legitimate.
Are clinical trials good?
They help expand medical treatment options and improve public health outcomes through research-backed evidence.
Are clinical trials FDA approved?
Trials must be reviewed by the FDA before starting in the U.S., but the term “FDA approved” applies to the drug, not the trial itself.
Are clinical trials free?
Yes. Trial-related tests, procedures, and medications are typically provided at no cost to participants.
Are clinical trials legal?
Yes. They are governed by national and international regulations and must be registered and approved before they begin.
Can clinical trials be observational?
Yes. Observational studies monitor health outcomes without assigning any treatment to participants.
Can clinical trials cure diseases?
Some trials may result in highly effective treatments, but the goal is to evaluate potential, not to guarantee a cure.
Can clinical trials be randomized?
Yes. Randomized trials assign participants to different groups to reduce bias and ensure reliable results.
Can clinical trials treat patients?
They may offer therapeutic benefit, but the primary objective is scientific evaluation, not guaranteed treatment.
Can clinical trials be double-blind?
Yes. In double-blind studies, neither the participant nor the investigator knows the treatment allocation, reducing bias.
Can clinical trials be placebo controlled?
Yes. Placebos help researchers measure the actual effect of an investigational product by comparison..
How do clinical trials work? How are clinical trials done? How are clinical trials conducted?
Clinical trials are conducted in a structured and regulated manner using approved protocols. These protocols define the study objectives, patient eligibility, treatment plan, and assessment methods. The trials evaluate a treatment’s safety, efficacy, and impact by systematically collecting and analyzing data from participants over a defined period. Clinical trials begin with participant screening based on predefined inclusion and exclusion criteria. Eligible individuals are enrolled and monitored throughout the study. Data is collected at scheduled intervals through clinical assessments, laboratory tests, and patient-reported outcomes. All activities are conducted under ethics committee oversight and in compliance with Good Clinical Practice (GCP) guidelines.
How much do clinical trials pay?
Compensation varies depending on study design, duration, risk, and geographic location.
How are clinical trials paid for?
They are funded by pharmaceutical companies, research institutions, or government agencies (e.g., NIH, ICMR).
How are clinical trials designed?
They are designed based on the study objective, using defined endpoints, control arms, randomization, and statistical methods.
How long are clinical trials?
Duration ranges from weeks (Phase I) to years (Phase III or IV), depending on the treatment and therapeutic area..
How many clinical trials are there in the world?
As of 2025, over 470,000 trials are registered globally, covering a wide range of therapeutic areas.
How to find clinical trials?
Use public registries like ClinicalTrials.gov, WHO ICTRP, or sponsor websites for trial listings and contact information.
What are clinical trials used for?
To evaluate the therapeutic potential and safety profile of investigational products.
What are clinical trials conducted for?
For collecting data necessary to support regulatory filings and potential commercialization.
What are clinical trials needed for?
To bring new treatments to patients based on verified clinical data.
What are clinical trials about?
They involve testing hypotheses around medical interventions using defined methods and participant groups.
What are clinical trials looking for?
They assess treatment outcomes, adverse effects, biomarkers, and quality of life measures.
What are clinical trials required for?
They are mandatory for regulatory approval of new pharmaceuticals and devices.
What are clinical trials regulated by?
Regulated by agencies like the FDA (USA), EMA (EU), CDSCO (India), and international standards like ICH-GCP.
What are clinical trials governed by?
Governed by ethical, legal, and scientific frameworks including Good Clinical Practice (GCP) and national laws.
What are clinical trials approved by?
Approved by independent ethics committees and national regulatory authorities before starting.
What are clinical trials authorized by?
Authorized by regulatory bodies such as the FDA, EMA, MHRA, CDSCO, and others, depending on the location.
What are clinical trials monitored by?
Monitored by sponsors, CROs, site monitors, and data safety monitoring boards to ensure protocol compliance.
What are clinical trials overseen by?
Oversight is provided by principal investigators, institutional review boards, and regulatory authorities.
What are clinical trials audited by?
Audits are conducted by sponsors, regulatory inspectors, and independent auditors to verify quality and data integrity.
When did clinical trials start?
Formal clinical research began in the 1700s, with modern regulatory frameworks established in the 20th century.
When are clinical trials important?
They are critical during the development of new therapies and when existing treatments require improvement or alternatives.
Where are clinical trials done?
At approved research sites including hospitals, academic centers, and specialty clinics.
Where are clinical trials conducted?
In both single-country and multinational settings, depending on the trial scope and regulatory strategy.
Where do clinical trials take place?
At clinical research sites selected for their capabilities, infrastructure, and compliance history.
Where are clinical trials located?
They are conducted globally, with site selection based on disease prevalence, patient access, and site performance.
Where are clinical trials held?
At registered locations with trained investigators and infrastructure for patient safety and data collection.
Where are clinical trials performed?
Performed by certified investigators under supervision, following approved protocols and GCP guidelines.
Where are clinical trials managed?
Managed by contract research organizations (CROs), sponsors, or in-house clinical teams overseeing execution and compliance.
Where are clinical trials overseen?
Oversight is provided by investigators, ethics committees, sponsors, and regulatory inspectors.
Where are clinical trials monitored?
Monitoring is done regularly, either on-site or remotely, to ensure protocol adherence and participant safety.
Where are clinical trials audited?
Audits take place at investigator sites, sponsor offices, or CRO facilities to assess data integrity and regulatory compliance.
About Lambda: Lambda Therapeutic Research is a leading full-service Global Clinical Research Organization (CRO) headquartered in Ahmedabad (India), with facilities and operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), London (UK), Barcelona (Spain), and Warsaw (Poland). Lambda provides comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. With a commitment to excellence, our experienced team of 1200+ professionals utilizes cutting-edge technology and innovative solutions to provide a full spectrum of clinical trial solutions spanning from preclinical research to post-marketing studies. Over two decades of dedication to excellence has earned us numerous accolades, including the distinction of ‘Best Indian CRO’ by Frost & Sullivan (USA) and the coveted title of ‘Great Indian Workplace’ by UBS Transformance. Lambda Therapeutic Research has been recently honored with the ‘Regulatory Excellence’ Award at the CPHI Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.
