Clinical trials are rigorous research studies conducted to know how safe and effective new treatments, interventions, or preventive measures are.
Evidence from these studies, informs medical decisions and drives healthcare innovation.
In this blog post, we will discuss the basics, processes, benefits, and risks of clinical trials that can help shape our decision about whether or not to participate in them.
Basics of Clinical Trials
Clinical trials are scientific studies that aim to find answers to important medical questions. There are different types of clinical trials and they mostly involve researchers, participants, and interventions.
The team of researchers carefully plan and conduct the study. They are like detectives, trying to uncover valuable information that can improve healthcare.
In a clinical trial, participants play a crucial role. They volunteer to be part of the study and may receive a new treatment, intervention, or placebo (a harmless inactive substance) for comparison.
Participants come from different backgrounds and may have different medical conditions. The more diverse the background of participants, the better the results as they can be extrapolated to the general population.
The interventions being tested: can be medications, therapies, devices, lifestyle changes, or preventive measures.
Researchers want to know if these interventions are safe, effective, and better than what is currently available.
Phases of Clinical Trials
Clinical trials progress through different phases. There are 6 major phases of clinical trials, each serving a specific purpose. They include:
A: Preclinical Studies:
Before advancing to human trials, researchers perform preclinical studies using animal models to determine the safety and initial effectiveness of the intervention.
These studies involve testing the intervention in animals to assess its potential effects, the appropriate dosage range, and any adverse reactions that it may cause. The data obtained from preclinical studies influence researchers' decisions on whether to proceed with human trials.
B: Phase 0: Exploratory Trials:
In this phase, researchers gather initial data on a new drug or intervention. They want to understand how the intervention behaves in the human body and its potential effects.
This phase helps researchers decide if it's worth moving forward to larger studies.
C: Phase I: Safety and Dosage Assessment:
Phase I trials focus on assessing the safety and determining the right dosage range of the intervention.
A small group of healthy volunteers participates, and researchers closely monitor any potential side effects. This phase helps identify the appropriate dosage for further study.
D: Phase II: Effectiveness and Safety Evaluation:
Phase II trials involve a larger group of participants who have the condition or disease targeted by the intervention.
The study assesses the intervention's effectiveness and continues evaluating its safety.
Researchers collect more data to determine if the intervention shows promising results.
E: Phase III: Comparison with Standard Treatments/ Placebo:
Phase III trials compare the new treatment or intervention to existing standard treatments or placebo.
It involves a large population of participants and aims to determine if the new intervention is better, safer, or more effective than what is currently available. This phase provides valuable evidence for regulatory approval.
F: Phase IV: Post-Marketing Studies:
After a treatment or intervention is approved, Phase IV studies are conducted for long-term monitoring of safety and effectiveness.
These studies provide ongoing information about the intervention's benefits and potential risks in a larger population.
By progressing through these phases, clinical trials gather important data that helps researchers understand the potential benefits and risks of interventions, leading to improved healthcare options for patients.
The Clinical Trial Process
To conduct a clinical trial, researchers have to undergo several processes to ensure the success of the trial.
Here are 7 major steps in conducting clinical trials:
1. Planning and Protocol Development:
Before a clinical trial begins, researchers carefully plan the study by defining research objectives and creating a protocol.
The protocol outlines the study design, eligibility criteria for participants, and procedures for data collection. It serves as a blueprint that guides the entire trial.
To illustrate, researchers planning a clinical trial for a new cancer drug will determine the specific goals of the study, such as its ability to shrink tumor size. They will also establish criteria for participant eligibility, such as age, stage of cancer, and previous treatments.
2. Recruitment and Enrollment of Participants:
To carry out a clinical trial successfully, researchers need to recruit eligible participants. They employ various methods to identify and engage people who meet the study's criteria.
Recruitment efforts may involve collaborating with healthcare providers, advertising in relevant communities, or using online platforms.
For instance, in a clinical trial for diabetes treatment, researchers may reach out to diabetes clinics and specialists to find potential participants who fit the specific requirements, such as age, type of diabetes, and certain health markers.
Others like Infiuss Health, a patient recruitment platform, have a database that makes it easy to find eligible participants in different parts of Africa.
3. Informed Consent Process and Participant Rights:
The informed consent process is important so that any participant in a trial would have a clear understanding of the trial, its purpose, potential risks and benefits, and their rights as participants.
Participants are provided with detailed information in a language they can understand and have the opportunity to ask questions before voluntarily deciding to participate.
They will be asked to sign a consent form indicating their voluntary agreement to participate and they can withdraw at any time during the trial.
4. Implementation of Interventions and Data Collection:
Once participants are enrolled, the interventions or treatments outlined in the study protocol are implemented. This may involve administering experimental drugs, providing specific therapies, or using medical devices.
Data collection methods, such as surveys, medical tests, or patient diaries, are used to gather information related to the trial's objectives.
Data on their responses and potential side effects may be collected through blood tests, or other investigative methods and regular follow-up assessments.
5. Monitoring and Safety Measures:
Throughout the trial, researchers closely monitor participants' health and well-being. Regular check-ups, assessments, and lab tests are conducted to detect any adverse events or changes in response to the intervention.
Rigorous safety measures and ethical guidelines are in place to protect the participant's welfare.
Any potential risks are promptly addressed to ensure participant safety.
6. Analysis and Interpretation of Data:
Once data collection is complete, researchers analyze and interpret the gathered information.
Statistical methods are applied to determine the effectiveness of the intervention, potential side effects, and any other relevant outcomes.
This analysis forms the basis for drawing conclusions and making informed decisions about the intervention's future.
7. Publication and Dissemination of Results:
The final stage involves the publication and dissemination of trial results. Researchers share their findings in scientific journals, conferences, or other relevant platforms.
This transparency allows the broader scientific community and healthcare professionals to benefit from the knowledge gained and facilitates further advancements in medical research and patient care.
The research team may present their findings at a medical conference, publish them in a peer-reviewed journal, or share them with healthcare professionals through online platforms.
By disseminating the results, they contribute to the body of scientific knowledge and enable other researchers and clinicians to evaluate and potentially integrate the new approach into clinical practice.
Benefits and Risks of Clinical Trials
Benefits for Participants
Participating in clinical trials offers several potential benefits for individuals who volunteer. The top 5 benefits include:
Early Access to Promising Therapies:
Clinical trials often involve investigational treatments that are in the early stages of development. By participating, individuals may have the opportunity to access these therapies before they become widely available.
This early access can be particularly beneficial for individuals with serious or rare medical conditions who may have limited treatment options.
Close Monitoring and Individualized Care:
Clinical trials involve close monitoring and frequent interactions with a team of healthcare professionals, including researchers, doctors, nurses, and study coordinators.
Participants receive personalized attention and care, as their health is closely monitored throughout the trial. This level of monitoring can lead to early detection of any changes or adverse effects, enabling prompt interventions or adjustments to the treatment plan.
Free medical care:
Clinical trials typically cover all of the costs associated with the trial, including medical care, travel, and lodging. This means that participants will not have to pay for any of the medical care they receive as part of the trial, such as doctor's visits, lab tests, or medications.
They may also be reimbursed for travel expenses to and from the study site, as well as lodging if they need to stay overnight.
Contribution to Personal Health:
Some clinical trials focus on preventive measures, such as vaccines or lifestyle interventions. By participating in these trials, individuals can take an active role in promoting their health and well-being.
They may receive guidance on adopting healthier habits or gain insights into preventive strategies that can benefit them long after the trial concludes.
Altruism and Making a Difference:
Participating in clinical trials allows individuals to make a meaningful impact on the lives of others. By volunteering, they contribute to the development of new treatments that can benefit future patients.
This sense of altruism and the opportunity to contribute to scientific progress can be personally fulfilling, knowing that their participation has the potential to help others and advance medical research.
Concerns and Risks for Participants
While clinical trials offer numerous benefits, it is essential to address common concerns and potential risks associated with participation. They are:
In certain trials, participants may receive a placebo, which is an inactive substance or sham treatment.
Placebos are used as a comparison to evaluate the effectiveness of the new intervention. However, it is important to note that participants in placebo-controlled trials still receive the standard of care for their condition.
Unknown Side Effects:
As clinical trials test new interventions, there is always a possibility of unknown side effects or adverse reactions.
Researchers follow strict safety measures and closely monitor participants to promptly identify and manage any potential risks or side effects that may arise. Participants must report any changes in their health or any concerns to the research team.
Time Commitment and Discomfort:
Clinical trials may require a significant time commitment, including frequent visits to the study site and adherence to the study protocol. Some procedures or interventions may involve temporary discomfort or inconvenience.
It is important for participants to fully understand the trial's requirements and assess whether they are willing and able to commit to the study's demands
Q: How long do clinical trials last?
Clinical trials can vary in length depending on the study. Some trials last a few weeks, while others can span several years.
The duration is influenced by factors like the research question, phase of the trial, and number of participants involved.
Phase I trials focusing on safety and dosage can take a few months.
Phase II trials evaluating effectiveness and safety data can last several months to a couple of years.
Phase III trials, comparing new treatments to standard ones, may span several years.
Phase IV trials monitoring long-term safety and effectiveness are often conducted after regulatory approval.
The specific duration is provided to participants during the informed consent process.
Q: Where are clinical trials conducted?
Clinical trials can be conducted in various settings, including hospitals, research centers, academic institutions, and private clinics. They may take place locally or span multiple locations, depending on the study's scope and participant recruitment.
Q: Why do we conduct clinical trials?
Clinical trials are conducted to gather scientific evidence about the safety and effectiveness of new treatments, interventions, or preventive measures. They help determine if a new approach is better than the existing options, improve patient outcomes, and advance medical knowledge.
Q: What is the difference between cohort and clinical trials?
Cohort studies follow a group of individuals with certain characteristics over time to observe outcomes, while clinical trials involve an intervention or treatment assignment to evaluate its effects.
Clinical trials typically have control groups and randomization, allowing for a more rigorous assessment of cause-and-effect relationships.
Q: What are the three components of a clinical trial?
The three main components of a clinical trial are the researchers conducting the study, the participants who volunteer to be part of the trial, and the interventions or treatments being evaluated.
Q: What is a clinical study vs. clinical trials?
The terms "clinical study" and "clinical trial" are often used interchangeably.
Both refer to investigations involving human participants to evaluate biomedical or behavioral interventions, but "clinical study" is a broader term that encompasses various research methodologies, including clinical trials.
Q: Is a clinical trial an experimental study?
Yes, clinical trials are considered experimental studies as they involve testing new treatments, interventions, or approaches. However, it is important to note that not all experimental studies are clinical trials.
Q: Why is it called a clinical trial?
The term "clinical" in clinical trials refers to the fact that these studies involve direct interaction with participants in a healthcare or clinical setting.
The term signifies that the research is conducted with human participants under controlled conditions with medical oversight.
Clinical trials are crucial for advancing medical knowledge, improving treatments, and enhancing patient care.
By understanding the basics of clinical trials, their processes, and the associated benefits and risks, individuals can make informed decisions about participation and contribute to shaping the future of healthcare.