What is Clinical Research?
Clinical Research are studies done using humans as volunteers or participants to advance medical and/or scientific knowledge and find better ways to learn about a disease, diagnose, treat and/or prevent a disease or illness.
There are two classifications: clinical or interventional trials and observational trials. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators. In observational studies, no new treatment is offered
Clinical trials are at the heart of many, if not all medical advances. It can be used to study new surgeries or drugs/new drug combination, new medical devices, new ways to utilize current treatments available or new ways to improve the quality of life for patients with varying disease severities. These trials always do put into consideration the efficacy and safety of these medical advances.
Different types of clinical research are used based on what the research wants to study.
- Prevention – to find better ways of preventing disorders from developing or returning with the use of medicines/vaccines, vitamins, minerals or lifestyle changes.
- Treatment – usually involves the use of an aid or intervention such as medication, a medical device, psychotherapy or a new approach to surgery or radiation therapy
- Screening – to find a better way to detect certain disorders or health conditions
- Diagnostic – somewhat similar to screening; seeking better ways to identify a particular disorder or condition
- Genetic – to improve the prediction of disorders by identifying and understanding how genes or illnesses may be related; how a person’s genes may or may not make him/her more predisposed to a certain illness or disease
- Epidemiological - to identify the patterns, causes and control of disorders in patients.
- Quality of Life research – also supportive care; to explore ways of improving the comfort and quality of life for individuals with a chronic or terminal illness
Why participate in a clinical trial?
Many people may not think about it but the fact is anyone who has ever taken a medication has benefited from clinical research. Clinical research provides insight into safety and effectiveness of medical treatments and procedures. It also helps medical researchers gain access to new research treatments before they become widely available to the public. Participants in clinical research can also have a more active role in their health through the extra checks done during the study.
Who can participate in a clinical trial?
Different types of people can participate in clinical trials; healthy people can participate for the purposes of providing new information or techniques; they do not have any direct benefit from the trials. People with illnesses also can participate in clinical trials but must be based on certain criteria which the different studies dictate.
All clinical trials have guidelines about who can participate. Inclusion (criteria that allow participation) and exclusion (criteria that do not allow participation) criteria are some of the guidelines used in enrolling patients into trials to produce accurate and reliable results. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must be eligible for enrolment into the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. These criteria are used to identify appropriate participants, ensure their safety and also help ensure that researchers will be able to answer the questions they plan to study.
Is Clinical Research the same as Medical Care?
Clinical research should not be confused with routine medical care. Sometimes it gets confusing especially when the medical provider is also the researcher or study doctor. When a patient is involved in a clinical trial, the study protocol that contains all the set plans for the study must be followed and cannot be adjusted to suit the patient’s needs compared with regular or routine medical care where treatment and procedures can be adjusted to meet the needs of the patient. When a participant in a clinical trial does not want to continue with a research protocol, there is always the option to opt out of the study instead of adjusting the protocol as that will lead to incorrect and unreliable results obtained for the study.
Phases of clinical trials
Clinical trials are conducted in phases or steps and each phase has a different goal which researchers use to answers various questions required before getting a drug approved.
Phase I: Conducted in a small group of people (under 100) for the first time to study the drug or treatment and to learn about safety and side effects. Participants are often started with a very low dose and monitored closely until a dose with acceptable side effects is reached – the best dose with the fewest side effects. Safety is always a major concern here.
Phase II: Conducted in a much larger group of people, a few hundreds, to determine the effectiveness and efficacy and also to obtain more knowledge on the safety of the drug or treatment from results in Phase I. Patients in this phase must have the disease for which the drug is intended. Criteria for participation in this phase are very strict and selective.
Phase III: Conducted in a larger group of people (>1000) to confirm the drug/treatment effectiveness and compare it with other similar treatment (s), monitor side effects and obtain more information on its safety. This can last several years.
Phase IV: Here, researchers track the long term safety of the drug or treatment on the user’s quality of life after it has been made available to the public for use (Post marketing surveillance trials). Researches can also check for the cost-effectiveness of the drug compared to other therapies or just to compare with what is already available in the market. Even at this stage (after approval), a drug/treatment can have restricted use or taken off the market depending on results obtained from the study
What is informed consent?
Informed consent is the process for getting permission before performing any healthcare related intervention on a person. In clinical research, a patient is always asked to sign an Informed Consent Form (ICF) before any procedures are performed to show that the patient understands the study and what they are being asked to do. Consent for a clinical trial usually involves more information than consent for the regular standard of care treatment at a clinic or hospital. The research Informed Consent usually contains the following information (not exclusive list):
- The reason and explanation of the purpose of the clinical trial or study
- The expected duration of the study
- A description of the procedures to be conducted
- The risks and benefits and what is known and not known about the drug or procedure
- Persons to contact with questions or concerns about the study
- Alternative treatment options and opting out of a study for various reasons
- Confidentiality of PHI during and after the study
- Additional cost to the participant
- Statement of risk
(Source: ClinicalTrials.gov, nih.gov, Wikipedia, University of Virginia school of Medicine, fda.gov)