What Are Clinical Trials

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cience is only as good as the evidence it is based upon. Since medical science has such a vital effect on our health it is important that every decision is based on strong clinical evidence. This evidence that is provided by clinical trials and research. The National Institutes of Health (NIH) describe clinical trials as “research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans” (1). Clinical trials often look for both healthy participants and individuals with specific conditions. Paid clinical trials are sometimes available for individuals looking to be compensated for their time.

Importance of Clinical Trials

Clinical trials provide us with details about the effectiveness and safety of a clinical intervention. Many clinical trials help researchers come up with better treatment strategies for a certain disease, thus, some clinical trials compare the two treatment methods to find out which one is better and safer.

Clinical trials don’t study just the newest medications or interventions; they may be used to study the long-term effects of drugs and interventions that are already in common use. For example, recent clinical trials have found that hormonal therapy –which is already widely used- increases the risk of heart disease, stroke, blood clots and breast cancer. As a result, long-term use of hormonal therapy is no longer recommended in postmenopausal women (2).

Phases of Clinical Trials

Clinical trials are divided into phases. Each phase has different objectives and questions to answer. Scientists usually start a clinical trial on humans only after they have found a particular medication or intervention is effective in a laboratory or through animal studies. According to the FDA, clinical trials are carried out in four phases, with each phase building upon the knowledge gained from the prior phase (3). If the trial fails to fulfill its objective, it may be terminated (4).

Phase I Clinical Trial

Generally carried out in a very small group of people (usually 20-100 healthy subjects). The main objective of this trial is to understand safety, and safe dosages in humans.

Phase II Clinical Trial

In this phase, the trial is carried out on a larger group of people (several hundred people), and the objective is to know more about the effectiveness of medication or intervention, along with a collection of additional safety data.

Phase III Clinical Trial

Once the drug or intervention has been found safe and effective, it is tested on a much larger group of humans (usually few thousand) over the period of few years. If found effective and safe enough, it is given a marketing approval by FDA.

Phase IV Clinical Trial

The final phase, involving several thousand individuals suffering from the condition for which intervention or medication is being tested. Tests focus on the efficacy and safety on a much larger scale and in real life conditions.

It is also important to understand that not all clinical trials involve the study of new medications or interventions. For example, the genetic study of a group that suffers from a certain disease, or effect of living conditions on cardiac health.

Why do People Participate in Clinical Trials?

Everyone has different reasons to participate in a clinical trial. Healthy subjects mostly participate because they think that it is their duty to help science in moving forward. Many people suffering from diseases may participate in the hopes of getting better or cured. There are many medical conditions for which there is currently no effective treatment, such as HIV, different kind of cancers, or even asthma.

There are certain eligibility criteria to decide who can participate in every clinical trial. Some trials require the participation of older people, while others focus on younger adults. Some may need healthy volunteers while others need patients with a particular disease condition. Trials may also vary in duration and location where they would be carried out. In some trials, a person may need to travel or stay at the medical facility.

What are the Benefits of Participation in a Clinical Trial?

Benefits depend upon the phase or type of clinical trial. Clinical trials provide a person early access to the latest developments in the field of medicine. A person also gets attention from the best specialists in their field, along with much better diagnostics. Apart from the possibility of direct health benefits, individuals get an opportunity to play a role in the development of science.

How Safe are Clinical Trials?

There is no guarantee that a person would benefit from any particular clinical trial. Some interventions or medications may cause unforeseen and severe side effects.

A person is informed about the possible risks when signing the informed consent. It is also important to know that informed consent is not a contract and a person can withdraw from the study at any given time.

What Should a Person Know About the Trial?

Although fully understanding clinical trials can be difficult if you don’t have a background in science or healthcare, the official website of the US government for clinical trials has come up with a list of questions that may help a person to know more about clinical studies. Below is the list of questions you should ask before giving consent to participate (5);

  • Ask about the purpose of the clinical trial.
  • Ask about the possible benefits and risks from the trial, and if the trial with that particular intervention has been done earlier or not.
  • Ask about your options or compensation methods in case of injury.
  • Ask about the long term care provided, after the clinical trial has ended.
  • Ask about the financial benefits for participation and coverage of participation costs.
  • Ask about the length of the proposed clinical trial.
  • Ask if the study would require hospitalization or not.
  • Ask about the possible benefits of the intervention being tested, as compared to the treatment that is already being used.
  • Ask about the interventions involved in the trial, and what a person has to do for the participation, procedures involved, a number of hospital visits.

Available Clinical Research Trials

  • Music Utilization in Sedation and Induction in Colonoscopy
    on July 13, 2020 at 4:00 pm

    Condition:   ColonoscopyIntervention:   Other: Music: "Nada Himalaya" performed by S. G. SachchidanandaSponsor:   The Brooklyn Hospital CenterWithdrawn

  • Virtual Reality Treatment for Adults With Chronic Back Pain
    on July 13, 2020 at 4:00 pm

    Conditions:   Chronic Pain;   Back Pain Lower Back Chronic;   Back PainIntervention:   Device: Virtual Reality Therapy for Chronic PainSponsors:   CognifiSense Inc.;   University of Colorado, Boulder;   National Institute of Nursing Research (NINR)Enrolling by invitation

  • Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
    on July 13, 2020 at 4:00 pm

    Conditions:   Breast Cancer;   Triple Negative Breast Cancer;   PD-L1 NegativeInterventions:   Drug: Sacituzumab Govitecan;   Drug: PembrolizumabSponsors:   Dana-Farber Cancer Institute;   Immunomedics, Inc.;   Merck Sharp & Dohme Corp.Not yet recruiting

  • Phase 2 Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
    on July 13, 2020 at 4:00 pm

    Conditions:   Neuropathy;   Peripheral Neuropathy;   Neuropathic Pain;   Chemotherapy-induced Peripheral NeuropathyIntervention:   Drug: Nicotine Transdermal PatchSponsor:   Virginia Commonwealth UniversityNot yet recruiting

  • Fatigue in Patients With Amyotrophic Lateral Sclerosis
    on July 13, 2020 at 4:00 pm

    Conditions:   Amyotrophic Lateral Sclerosis;   Dysphagia;   Dyspnea;   Respiration DisordersInterventions:   Device: Experimental expiratory muscle strength training (EMST);   Device: Sham expiratory muscle strength training (EMST)Sponsor:   University of PittsburghNot yet recruiting

  • Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
    on July 13, 2020 at 4:00 pm

    Conditions:   HLH - Hypoplastic Left Heart Syndrome;   DORV;   DILV - Double Inlet Left Ventricle;   Mitral Atresia;   Tricuspid Atresia;   Unbalanced AV Canal;   Single-ventricle;   Heart Defects, Congenital;   Cardiovascular Abnormalities;   Cardiovascular Diseases;   Heart DiseasesIntervention:   Combination Product: Tissue Engineered Vascular GraftsSponsors:   Nationwide Children's Hospital;   National Heart, Lung, and Blood Institute (NHLBI);   Gunze Limited;   National Institutes of Health (NIH)Recruiting

  • Tart Cherry Supplementation & Gut Microbiome and Inflammation
    on July 13, 2020 at 4:00 pm

    Conditions:   Inflammation;   Glucose Regulation;   SleepInterventions:   Dietary Supplement: Tart cherry juice concentrate;   Dietary Supplement: Juice placebo;   Dietary Supplement: Freeze dried tart cherry powder;   Dietary Supplement: Capsule placeboSponsor:   Ohio UniversityActive, not recruiting

  • Eating Behaviors in Shift Workers
    on July 13, 2020 at 4:00 pm

    Conditions:   Shift Work Type Circadian Rhythm Sleep Disorder;   Eating BehaviorIntervention:   Behavioral: Portion sizeSponsor:   Columbia UniversityNot yet recruiting

  • The Baerveldt Versus ClearPath Comparison Study
    on July 13, 2020 at 4:00 pm

    Condition:   GlaucomaInterventions:   Device: Baerveldt 350 implant;   Device: Ahmed ClearPath 350 implantSponsor:   Duke UniversityNot yet recruiting

  • Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit
    on July 13, 2020 at 4:00 pm

    Conditions:   Amyotrophic Lateral Sclerosis;   Brainstem Stroke;   Muscular Dystrophies;   Parkinson's Disease and Parkinsonism;   Multiple System Atrophy;   Brain Tumor Adult;   Spinal Cord Injuries;   Locked-in SyndromeInterventions:   Behavioral: BCI-FIT multi-modal access;   Behavioral: BCI-FIT adaptive signal modeling;   Behavioral: BCI-FIT active querying;   Behavioral: BCI-FIT language modelingSponsor:   Oregon Health and Science UniversityNot yet recruiting

  • A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)
    on July 13, 2020 at 4:00 pm

    Condition:   Healthy ParticipantsInterventions:   Drug: BMS-986278 Tablet;   Drug: Esomeprazole;   Drug: BMS-986278 suspensionSponsor:   Bristol-Myers SquibbNot yet recruiting

  • Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
    on July 13, 2020 at 4:00 pm

    Conditions:   Palsy Supranuclear;   Supranuclear Palsy, ProgressiveIntervention:   Device: Repetitive transcranial magnetic stimulation (rTMS)Sponsors:   Oregon Health and Science University;   National Center of Neuromodulation for Rehabilitation (NC-NM4R);   Collins Medical Trust;   National Institutes of Health (NIH);   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting

  • Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
    on July 13, 2020 at 4:00 pm

    Conditions:   Trauma;   InjuriesIntervention:   Other: Virtual Pediatric Trauma CenterSponsors:   University of California, Davis;   Patient-Centered Outcomes Research InstituteNot yet recruiting

  • MBCT for People With Parkinson's Disease and Caregivers
    on July 13, 2020 at 4:00 pm

    Conditions:   Parkinson Disease;   Anxiety;   DepressionIntervention:   Behavioral: Mindfulness-based cognitive therapy (MBCT)Sponsors:   University of California, San Francisco;   Mount Zion Health FundNot yet recruiting

  • ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
    on July 13, 2020 at 4:00 pm

    Conditions:   Hypertension;   COVIDInterventions:   Drug: ACEI/ARB;   Drug: Non-ACEI/ARB;   Drug: ACEI;   Drug: ARBSponsors:   University of Utah;   VA Salt Lake City Health Care System;   University of Pennsylvania;   Wake Forest University Health Sciences;   University of Florida;   Johns Hopkins Bloomberg School of Public Health;   Boston University;   Northwestern University;   Edith Nourse Rogers Memorial Veterans Hospital;   Columbia University;   MedStar Georgetown University HospitalActive, not recruiting

  • A Peer-mediated Vocational Social Skills Program for Young Adults With Autism
    on July 13, 2020 at 4:00 pm

    Condition:   Autism Spectrum Disorder High-FunctioningIntervention:   Behavioral: Assistive Soft Skills & Employment Training (ASSET)Sponsor:   Florida Gulf Coast UniversityActive, not recruiting

  • Effects of In-Wheel Suspension
    on July 13, 2020 at 4:00 pm

    Conditions:   Spinal Cord Injuries;   Fatigue;   Back Pain;   Neck PainIntervention:   Other: Suspension WheelSponsors:   University of Pittsburgh;   The Craig H. Neilsen FoundationNot yet recruiting

  • Specimen Collection Study Protocol
    on July 13, 2020 at 4:00 pm

    Condition:   Focus in on Collecting Paired Specimens for Matrix EquivalencyIntervention:   Sponsor:   BiomericaRecruiting

  • Transcutaneous Stimulation for Neurological Populations
    on July 13, 2020 at 4:00 pm

    Conditions:   Neurological Disorder;   Cerebral PalsyInterventions:   Other: Gait Training;   Device: Transcutaneous Spinal StimulationSponsors:   University of Washington;   Seattle Children's HospitalRecruiting

  • A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
    on July 13, 2020 at 4:00 pm

    Condition:   Multiple MyelomaInterventions:   Drug: 89Zr-DFO-daratumumab;   Diagnostic Test: PET/CTSponsor:   Memorial Sloan Kettering Cancer CenterRecruiting

Sources
  1. What Are Clinical Trials? – NHLBI, NIH. [cited 2017 Sep 10]. Available from: https://www.nhlbi.nih.gov/studies/clinicaltrials
  2. Why Are Clinical Trials Important? – NHLBI, NIH. [cited 2017 Sep 10]. Available from: https://www.nhlbi.nih.gov/studies/clinicaltrials/important
  3. What Are the Different Types of Clinical Research? [cited 2017 Sep 10]. Available from: https://www.fda.gov/forpatients/clinicaltrials/types/default.htm
  4. US FDA. The Drug Development Process – Step 3: Clinical Research. 2017 [cited 2017 Sep 10]. Available from: https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm
  5. Learn About Clinical Studies – ClinicalTrials.gov. [cited 2017 Sep 10]. Available from: https://clinicaltrials.gov/ct2/about-studies/learn