Your Beginner’s Guide To Clinical Trials:
This Beginner’s Guide will tell you what a clinical trial is, phases of clinical trial and its Terminologies .
What are clinical trials?
Any drug which comes into the market and is available for human use, it must go through a stringent and elaborative process of testing known as clinical trials.
A Clinical trial is one of the final stages of a long and careful research process. studies are done with patients to find out whether promising approaches to prevention diagnosis and treatment are safe and effective.
Clinical trials can take around 10 to 15 years to complete but this time span may vary a lot, it costs millions of dollars and it’s crucial for an organizations survival.
Why are clinical trials done?
Clinical trials are conducted for many reasons:
- to determine whether a new drug or device is safe and effective for people to use.
- to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
Phases of clinical trials:
Phase 1-Is the Treatment Safe?
After an experimental drug or treatment has been tested in the lab /animals.it enters a phase 1 trial.
these trials involve a small number of patients to test safety in humans and determine the correct dose of drug.
these trials also helps in determine the best way to give the drug whether oral or intravenuosly.
POPULATION:
Healthy volunteers or individuals with the target disease (such as cancer or HIV) individuals with target disease, as well as new age groups , genders,etc.
SAMPLE SIZE:20 to 80
DURATION: up to 1 month
Phase 2:Tests the efficacy of the device or the drug:
The second phase of study tests the efficacy of the device or the drug. This second phase of study can last up to several months or upto two years and includes multiple patients. Most of the second phase of studies are unsystematic trials where a group of patients is divided into two, the first group of the patients get the experimental drug while the second half of the whole group gets a standard treatment or a placebo. Often this phase is blinded which signifies that neither the researcher nor the patient is aware of which group received the experimental drug.
POPULATION: Multiple patients
SAMPLE SIZE:100–300
DURATION: up to 2 years
PHASE 3- Does the new treatment work better than the standard treatment?
phase 3 trial test the new drug or treatment or hundreds or thousands of individuals.
these studies are often “double blind” trials, which mean that neither the patient nor the investigator knows which treatment being used.
they are designed to answer the questions of whether or not the new treatment works better or has fewer side effects than the standard treatment.
POPULATION: Individual with target disease.
SAMPLESIZE: Hundreds to thousands
DURATION: several years
phase4-Is the treatment safe over time?
Phase 4 trials are less common and serve to answer questions after FDA has already approved a drug for general use.
these can address questions such as long term safety of a drug or circumstances in which the drug may be helpful.
POPULATION: Individuals with target disease as well as new age groups, genders etc.
SAMPLE SIZE: Thousands
DURATION: ongoing(following FDA approval)
Clinical trial terminologies:
Protocol:
The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
SAP(Statistical Analysis Plan):
The SAP is very detailed document , separates from the protocol, describing how the clinical trial will be analyzed .it includes draft output shells these shows precisely what tables, listings, and graphs will be provided in the reporting
Tables: summarizing the data
Listings: listing the data
graphs: graphical representation of data
CRF(Case Report Form):
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor for each trial subject.
Informed consent:
the acknowledgement that an individual understands and agrees with the purpose ,procedures, risks and requirements before participating in an experiment.
Randomization:
the process of assigning trial participants to treatments groups based on chance in order to reduce potential bias.
Safety Population:
all patients with intake of at least one dose of study medications after randomization.
Screening Population:
All patients who have signed the informed consent form.
ITT population:
the intent to treat population will comprise all patients who were randomized who were known to take at least one dose of treatment based on the randomized treatment not the treatment actually received.
Per-Protocol Population:
it will include all subjects who complete the study without any major protocol violations.
Conclusion:
In this blog, I have presented you with the basic concepts of clinical research. I hope this blog was helpful and would have motivated you enough to get interested in the topic
