Clinical Trials are studies performed as a part of research to test or study the effectiveness of a medical, behavioral, or surgical intervention. It is the fundamental practice of assessing the efficacy of a new drug or device. While some trials are conducted to test the effectiveness of a drug or device, others aim to find out preventive options or simply ways to find understand disease states and how they work. The trials help in controlling the factors that could impact the outcomes of the research study. There are various paid clinical trials for healthy volunteers interested in taking part in advancing health care.
In this blog, we will be discussing in detail Clinical Trials, their steps, participation, importance, risks, and benefits.
What Are The Different Types Of Clinical Trials?
Before jumping into the details of Clinical Trials, let’s first understand the different types of research. Broadly, research is classified into two branches, Observational Studies, and Clinical Trials.
Observational studies are those studies where a researcher observes the effects of risk factors of an interventional drug or device. As the name suggests, the researcher observes the subjects and documents data based on their observation.
On the other hand, Clinical Trials involve testing the latest methods of treating, screening, preventing, and diagnosing disease, be it through an investigational drug, medical device, or diagnostic methods. They help to assess the safety and effectiveness of those drugs or medical devices.
The Aim Of Paid Research Studies:
The trials are conducted to test whether the treatment or procedure is safe, its side effects, its effects on quality of life, and also to check if the new treatment is better than the previous one or the one currently in use. Every drug or device that is now on the market was once a part of a clinical trial.
Clinical Trials And Its Types:
There are different types of trials within the two broad categories of Observational Studies and Clinical Trials. These include:
- Pilot Study and Feasibility Study: These studies are done before getting to the larger part of the research.
Pilot studies test all parts of the study together. The information is gathered during the pilot study that is incorporated into the main study.
A feasibility study is to test the practicality of the main study, whether it is feasible to conduct it by looking at certain different aspects like the interest of patients and doctors in the study, how the management and operational activities will be executed, etc.
- Prevention Trials: These trials identify if a treatment helps in the prevention of a disease like cancer.
- Screening Trials: These trials are open to the general population to check for early signs of diseases like cancer, even before the symptoms appear.
- Treatment Trials: These trials run in different stages called phases. The early or initial phase is to test the safety and side effects of a new treatment.
- Multi-arm Multi-stage Trials (MAMS): It has several different test groups, whereas the control group is the same throughout the study. In MAMS, the researcher has the authority to add new participants for a new study or to stop recruiting and work on figuring out the results.
Phases Of Clinical Trials:
Clinical trials are run in different phases. Each phase holds its own importance without which the other phases would be incomplete. There are 3 major phases of a Clinical Trial — I, II, and III. Some trials have phases that start from 0 and end at IV.
0 is an earlier phase, whereas phase IV is done after the drug has made it out into the market for public use.
Phase 0: Between Preclinical and Phase I of the Trial:
This phase includes a very few numbers of participants, approximately around 15 participants. It tests the safety of the drug by testing it out on a small sample before experimenting with its high doses in the later phases.
Phase 1: To Test Drug Safety:
This phase includes 20 to 80 participants who are healthy. The effects of the investigational product are studied for a few months. The goal is to establish the highest dose humans can endure without serious side effects. About 70% of the investigational drugs move on to the next phase according to FDA.
Phase 2: To Test Drug Effectiveness:
This phase includes several hundred people who are suffering from the condition — the main reason for conducting the trial. Around 33% of drugs move on to the next phase according to FDA. This phase also studies the side effects of the drugs, if any, and prepares for the next phase.
Phase 3: To Test the Safety, Effectiveness, & Duration of Drug Action in a Larger Population:
This trial phase can last for several years. It includes thousands of participants living with the disease state and searching for potential treatment options. They gain access to this potential treatment option through the Clinical Trial being conducted. Phase III basically tests the effectiveness of the study drug in comparison to the existing drug. These trials are usually double-blind, meaning both participant and investigator are unaware of the medication the participant is taking. This eradicates bias. FDA approves the drug to be introduced to the market after phase III.
Around 25% to 30% of drugs in this stage make it to phase IV according to FDA.
Phase 4: Post-marketing Testing of the Drug:
To study the long-term effectiveness and safety of the drugs after they are available to the general public use, phase IV trials take place. This phase lasts for years. And the goal of this phase is to monitor the effects of the drug if any when used by the general population.
Role Of FDA In Paid Research Studies:
U.S. Food Drug and Administration (FDA) attempts to safeguard participants’ rights in a research study and to guarantee that individuals have reliable data prior to choosing whether to join a clinical trial. The Federal government has guidelines and rules for a clinical examination to safeguard participants from absurd dangers.
FDA ensures that investigational treatments are safe and viable for individuals to utilize. They don’t execute new treatments or lead clinical research. Rather, they supervise individuals who do. FDA staff meet with researchers and perform examinations of study sites to safeguard patients’ privileges and confirm the quality and respectability of the information.
Role Of Institutional Review Boards In Clinical Trials:
The Institutional Review Board or IRB is a body of professionals that looks after the human rights and welfare of individuals taking part in a clinical trial. It has a huge standing in a research study as they have the authority to accept, reject, or request modifications in the study. IRB has a set of standards to which they require every study to implement for the safety and rights of the participants, and declare their approval accordingly.
Informed consent is proof from the research organization that they have thoroughly guided the participants. However, the IRB reviews the consent form and cross-checks the particulars to ensure the reliability of the organization and that none of the stated ethical rules that could harm a participant or their safety is compromised.
Participation In Clinical Trials: Who Should Consider Participating?
Certain individuals take part in research studies due to the failure of the regular treatment choices, or because they can’t endure specific secondary effects. Clinical research gives another choice when standard treatment has fizzled. Others partake in research since they need to add to the headway of clinical information. Various clinical organizations in the US offer paid clinical trials for healthy volunteers who are determined to find a cure for people suffering from complex conditions.
All research studies have rules, called Participation Criteria, about which individuals may be allowed to partake. Participation depends on factors such as age, sex, type and phase of illness, past therapy history, and other ailments. This assists with decreasing the variety in the study and guarantees that the researchers will actually get the opportunity to address the illness they intend to study. Subsequently, not every person who applies for a clinical trial may be able to participate.
What Should I Be Aware Of Before Joining A Clinical Trial?
Prior to joining a clinical trial, it is essential to understand and learn however much as could be expected. Firstly it is important to understand that these are paid research studies in which the sponsors pay you for your participation. Talk about your apprehensions with the medical care group leading the trial. Likewise, examine the research study with your medical care provider to decide if the research study is a decent choice in view of your ongoing therapy. Be certain you understand:
- What occurs throughout the duration of the trial,
- The type of treatment you will be receiving,
- Any connected expenses or benefits, when you sign up for the trial, and
- The risks and benefits related to participating.
Do I Have To Pay To Participate In A Trial?
The answer is no. Participants do not have to pay from their pocket. From traveling costs to meals, sponsors cover it all. You just have to fulfill the eligibility criteria and you are good to go. Although the details are shared with the participants before the trial begins, in case you are not informed about the expenses, you have the right to ask for compensation for the trial.
How Can I Get Full Information Regarding Paid Research Studies?
Informed consent is one of the establishing standards of ethics in research. Its expectation is that people can join research willingly while discussing in detail how it affects them when they participate and that they give assent before they join the study.
Assent or consent should be obtained before an individual enters the trial and there should be no undue impact on people to give consent under pressure. The base necessities for agreeing to be educated are that the member comprehends what the trial is and what they are consenting to.
The consent form includes all the details of the trials from the security of your personal information to all the steps involved in executing the trial. It is a very precise document that leaves no ambiguity once you have completely read and understood it. A consent form includes a description of the trial, risks, and benefits of the trial, alternative treatment options, confidentiality, and compensation, and also gives you a free hand to accept or reject spending on your circumstances and willingness.
What Are The Risks Of Partaking In A Clinical Trial?
No matter how good a study and its investigational treatment might seem, it can still have certain side effects that can seriously impact one’s health. It is important to weigh the risks and benefits to come to a rational conclusion. Other than the side effects, the duration of the trial may be longer than you could manage. It may include complex dosage timetables that may not be feasible for you. Participants should be aware of the fact that they might not receive the actual drug and may be on a placebo that has no effects.
It is crucial to look for well-reputed organizations conducting paid research studies so that the entire process is smooth for you.
What Are the Benefits Of Enrolling In A Clinical Trial?
Well-managed and well-implemented trials can be a success and provide you with an opportunity to be a part of a noble cause. Some of the advantages include:
- Helping others suffering from complex diseases find a suitable treatment
- Obtaining access to new treatments before they are out on the market
- Regular checkups and quality care by a team of medical professionals
How Do I Make Sure That My Privacy Will Not Be Breached?
Several methods are adopted to ensure the privacy protection of the participants. The data is stored in locked cabinets, assigning codes to participants for identification and keeping their identity anonymous. Data is also kept encrypted meaning that only those people can view the details who have that particular code or password. Before a study is conducted, all the processes are thoroughly reviewed including the participation and privacy of a participant.
Why Are Clinical Trials Important?
Clinical trials play an essential role in the advancement of research. Paid research studies help to detect, diagnose, and prevent certain conditions. Novel treatments are always a way forward in the field of medicine. The trials propose new treatment choices for complex diseases and help to make the lives easier of people suffering from those complicated conditions.
While the trials are essential, the choice to take part in the trials totally depends on you and no one can force you. It is a very personal decision for which you need to discuss with your doctor, and, the pros and cons of that particular trial for you.
Needless to say, the future of Clinical Trials looks promising. For the betterment of the healthcare industry and people with complex conditions, staying up to date in regards to the viability of new therapy choices including drugs and medical devices, and monitoring them intently is the best approach to revolutionize the research industry. In this regard, paid research studies help in bringing the much-required shift. If the trials are fruitful, they can likewise contribute to a better quality of life and ultimately a success for the medical and research industry.