Researchers are continuously working towards the development of new drugs and treatments to help combat disease. However, early drug discovery only results in one out of 10,000 making it to market.
This process takes 14 years on average and over two billion dollars. As such, the time, resources, and skill set devoted to new medications are extremely competitive and only the most promising advance.
Researchers consider the need for a specific drug, how our bodies absorb and tolerate the drug, and the potential benefits. Once the drug passes these critical milestones, clinical trials are considered.
Clinical trials are research studies dedicated to developing new drugs, diagnostic tools, and clinical procedures. They play a crucial role in advancing science and are an essential option for many patients.
Clinical trials are stringently monitored to protect patients from any possible harm, which is done through review committees. These committees are called Institutional Review Boards or IRB, and researchers must submit data during each stage to be allowed to move forward.
Doctors must review any potential risks and benefits of the drug with the patient before starting the trial. Also, an informed consent document must be provided, outlining the purpose, procedures, and potential side effects of the drug.
Patients may leave a clinical trial at any stage but should consult their doctor to ensure it is safe to do so.
Clinical trials are vital for researchers and physicians to advance modern medicine and improve the quality of life for future patients. All the drugs and tools we use today are available because patients volunteered in clinical trials.
All the information collected from clinical trials gives us a better understanding, new knowledge, unexpected breakthroughs, smarter technology, and a more efficient standard of care.
What are the different stages of clinical trials?
Every clinical trial has eligibility criteria that need to be met to participate. This can be age, gender, medical condition, or other specific factors.
There are generally four phases to a clinical trial. Safety is the main priority in all stages; if stage 0 or 1 does not have positive outcomes, it will not proceed to the next stage.
Late-stage clinical trials generally separate participants into two groups. A computer randomly assigns the participants to one of the two groups to eliminate bias.
A double-blind study means the researchers, doctors, and patients are unaware of who is in each group.
A single-blind study means only one (researcher, doctor, or patient) group is aware of who receives the new treatment. A placebo will look identical to the new treatment but without the active ingredient(s).
Are clinical trials free?
Clinical trial costs are broken down into two categories: patient care costs and research costs.
Patient care costs are often covered through health insurance and refer to:
standard drug treatments,
treatments to improve symptoms or side effects from trial therapies,
other imaging tests.
Research costs are not generally covered through health insurance but are typically covered by the trial’s supervisor. These costs include:
the study drug,
lab tests completed for research purposes, and
added x-rays and imaging tests performed exclusively for trial data.
Some research studies pay participants for their time and effort, but cancer clinical trials do not pay participants.
Fortunately, U.S. federal law requires most insurance companies to cover “routine patient care costs” incurred during an approved clinical trial, and trial sponsors usually cover the rest.
It's important to note that participants involved in clinical trials will have more doctor visits to monitor side effects and treatment outcomes than the regular standard of care. This can result in having more travel, housing, and childcare costs which may not always be covered by insurance or trial expenses.
Why do people drop out?
Participants can leave a clinical trial at any time and are not required to give a reason for choosing to end their involvement. Participants are advised to speak to their doctor about safely doing this to minimize any side effects.
There are various reasons people choose to leave a trial, but most leave due to:
inconvenience or appointment times conflicting with work or school,
possible drug interactions that were unknown at the beginning of the trial, and
unexpected costs associated with travel, housing, and childcare.
Clinical trials can be a long-term commitment, and it is important to speak with your doctor to fully understand what you are committing to before enrolling in the trial.
Are clinical trials safe?
Clinical trials have several layers of precautions in place to spot any harm or safety issues to participants.
Lab trials are completed with human cells and animal testing before they reach the clinical trial stage. The collected information is then presented to the institutional review board (IRB) for evaluation. The new treatment is approved or denied once these scientists, doctors, and board members review the information.
The clinical trial phases are in place to limit any danger to the participants. If dangers are discovered, the trial is paused or indefinitely halted. This ensures patient safety at every step of the process. Doctors are also legally responsible for presenting informed consent documents outlining any potential risks involved with the trial.
Doctors are not allowed to move forward with the new drug or treatment unless the patient fully understands all the risks outlined in the informed consent document. These risks will be updated throughout each phase of the trial if new risks are presented.
How can I find clinical trials near me?
An easy option is to sign up for a free online service that helps you find the right match by showing lots of trials and simplifying the jargon. Since most clinical trial protocols are not written with patients in mind, it can sometimes be difficult to understand what the trial involves or who is eligible.
You can also find clinical trials through reputable sites such as NIH’s clinicaltrials.gov or by speaking to your doctor.
Who participates in clinical trials?
The U.S. FDA completed a Drugs Trial Snapshot study in 2015 and 2019 to better understand who signs up for clinical trials, improve diversification of the participants, and determine which novel drugs gained approval.
In 2019, 48 new drug products received approval by the FDA, with 46,391 patient-participants. These trials consisted of 11 oncology, six hematology, six neurology, and five psychiatry and sleep disorder trials. They saw a substantial increase in female participants compared with the 2015 Snapshot study¹.
Participant demographics show that the majority of patients involved in clinical trials during 2019 are Caucasian women. In previous years the majority of participants were Caucasian men. Clinical trial patient demographics can vary widely year to year depending on the drugs approved for research². The importance of diversity in clinical trials is key to achieving well-rounded research data. The FDA created the transparency initiative, reflected by the Drug Trials Snapshots, which helps share information and improve diversity while still staying within the studies' eligibility criteria.
In 2019, the pharmaceutical industry devoted $83 billion to research and development. That number continues to grow annually but falls short relative to the health and economic impact of today’s major health threats¹.
Do patients get paid for clinical trials?
Some clinical trials pay participants to enroll as an incentive or cover time and travel costs associated with enrollment. The amount paid for a specific trial varies and can depend on factors, such as:
number of in-person visits required,
number of phone check-ins required,
diary entry and symptom tracking requirements,
time for study-related examinations,
the condition being studied,
length of study, and
the phase of the trial (earlier phases tend to involve more risk, so patients are generally paid more in these cases).
Health insurance must implement clinical trial coverage, regulated through the Patient Protection and Affordable Care Act² (ACA), for any approved clinical trial (grandfathered-in health plans do not apply). This law refers to clinical trials intended to study new methods to prevent, detect, or treat life-threatening illnesses.
Under the ACA, health plans can not keep patients from joining a clinical trial, limit or deny coverage of routine costs, or increase costs due to a patient joining a clinical trial.