Clinical trials are an important part of medical research, and can offer patients with serious diseases and conditions the unique opportunity to be a part of the development and testing of new treatments. If having a positive impact on the future health outcomes of individuals like yourself, who have a serious condition, is appealing to you, you may be considering clinical trial enrollment. But, before you commit to the process, it’s important that you know what to expect. In this post, you’ll get a look at what the main types of clinical research are, what a clinical trial is, what phases are involved in clinical trials, and what to expect from the enrollment process. Plus, we’ll answer some frequently asked questions surrounding sponsorship, safety, medications, exclusion criteria, and more!
The Main Types Of Clinical Research
When looking at clinical research specifically, there are two main types; observational and interventional. In an observational study, you can expect researchers to observe health outcomes, but no interventions are given to change the course of the condition, behavior, or environment. In an interventional study, participants are administered a new treatment, or procedure, to see if it improves health outcomes. Clinical trials are the latter category, and involve the administration of a new drug, treatment, or procedure to evaluate its effectiveness and safety.
What Is A Clinical Trial?
A clinical trial is a type of interventional study that evaluates the safety and efficacy of novel treatments, drugs, or procedures. They are conducted according to meticulous protocols that define objectives and criteria for participant selection, dosages, administration of the treatment, and the parameters that are examined to determine whether the treatment works. Clinical trials are typically conducted in four phases, with each phase having its own objectives, which we’ll outline more below.
How Do Clinical Trials Work Exactly?
There are numerous stages to clinical trials, with drug development beginning at the D&D stage – discovery and development. This is when compounds and future drugs are tested to see which look promising to move into the pre-clinical phase. Here is a brief look into the clinical trial phases that you might see during your clinical trial enrollment process.
- Pre-clinical Phase: The preclinical phase is the first step in drug development, and involves experimentation in animal models to determine safety and efficacy of a potential treatment. This information allows researchers to make an informed decision about whether a drug should be tested in humans.
- Phase 1: Once pre-clinical development is completed, the drug will enter phase one where it’s tested in a small group (30 enrollees) split between those with a condition, and those who are healthy volunteers. The purpose of this phase is to gather safety information, observe results between both groups, and take a look at the drug’s pharmacokinetics; i.e. how it behaves in the body.
- Phase 2: Phase 2 builds on phase 1’s research into the safety and dosing of the treatment, and looks into how effective the drug is. You may see clinical trials in phase 2 using randomized techniques and placebo’s. This phase consists of around 100 enrollees.
- Phase 3: A clinical trial that moves into phase 3 is looking promising on the safety and effectiveness front, but longer testing is needed to ensure that there aren’t any serious side effects. This is the final phase before a drug is submitted to the FDA for approval, and enrolls more than 100 people, upwards of 1,000s across multiple locations.
- Phase 4: A phase 4 clinical trial only takes place after a drug has gone through the marketing application with the FDA. For it to be approved, the developer must have adequate data from two, large, and controlled clinical trials. If the FDA approves the drug, then a phase 4 clinical trial can commence, which captures the effectiveness of the drug over a very long period of time to see if there are any side effects not found during early trials.
Clinical Trial Enrollment Expectations
For those interested in enrolling in clinical trials, it’s important to know that before formal enrollment, you will need to go through an extensive screening process, which may seem complicated and a bit daunting. Here is what to expect:
1. When looking at clinical trial listings, expect to see the name of the research study, what phase it is in, how long it will last for, the disease being studied and the purpose of the trial, as well as, the inclusion and exclusion criteria. These criteria usually gives age ranges, gender, and what the individual must be diagnosed for.
2. If interested in enrolling in a particular clinical trial, you will need to submit your information to a clinical trial coordinator. For example, at the Lynn Health Science Institute, you’d submit your information via the application on the specific clinical research study page, and then wait to hear back to be screened.
3. You will need to go through an extensive screening process. You’ll have to provide age, gender, the type and stage of the disease you have, previous treatment history, and a full medical history. This is used to establish your eligibility, to see whether you qualify to enter the clinical trial. If you do meet the inclusion criteria, then it’s likely that you’ll have further appointments to discuss the clinical trial in more depth.
4. As part of the screening process, you’ll be required to sign a form called informed consent. A sponsor representative will go through all elements of the clinical trial process with you, so that you understand the potential benefits and risks of the study. It is important that you understand the study thoroughly and what is involved, before you go through with voluntarily signing the informed consent form. The informed consent may outline any of the following:
a. Trial purpose, trial treatments, and trial procedures to be followed.
b. Participant responsibilities.
c. Aspects of the trial that are experimental in nature.
d. Any foreseeable risks and reasonably expected benefits to the participant.
e. Alternative procedures/courses of treatment available and their risks/benefits.
f. Compensation or treatment available for trial-related injuries if applicable.
g. Anticipated expenses.
h. Expected duration of participant’s time in the trial and approximate number of participants.
It is important to note here that your participation in the clinical trial is voluntary, meaning you can refuse to participate or withdraw at any time without penalty.
5. You may choose to have a patient organization or representative accompany you to ensure that you completely understand the informed consent process, and the language being used.
6. You can expect for there to be some time to ask questions. You may want to ask questions surrounding the medication/treatment, therapy interventions, type of tests, what is needed in terms of travel, if travel costs are reimbursed, if a detailed schedule will be provided for clinic visits, and who to contact if you have questions during the trial.
Frequently Asked Questions Associated With Clinical Trial Enrollment
1. What Does It Mean When a Clinical Trial is Sponsored? When enrolling in a clinical trial, you may hear or read that it is “sponsored”. This simply means that an organization has taken on the responsibility of initiating, managing, or financing the study, and/or has a vested scientific interest in the drug or device that is being tested in the trial. It’s important to note here that sponsors do not conduct the investigation themselves.
2. Do All Medications Go Through Clinical Trial Testing? Yes, all medications, including orphan drugs, must go through clinical trials before they can be approved by the Food and Drug Administration (FDA). The FDA requires strict safety and efficacy trials in order to determine the safety and effectiveness of a drug or device before it can be used in humans.
3. Drug Trial Types? There are generally new drug trials, and repurposed drug trials. With new drugs, these are not commercially available, which means that you won’t have access to it after the trial ends. With repurposed drugs, these are drugs that have already been developed and are commercially available, but are being tested as a treatment for a different condition than their original intention.
4. What Are Orphan Drugs? A drug is given an “orphan designation” if it’s meant to treat a rare medical condition. In the United States, the FDA defines a rare medical condition as one that impacts fewer than 200,000 people. Sponsors of “orphan” drugs receive various incentives like tax credits, exemptions from fees, and market exclusivity post-approval, as a way to expedite drug development for underserved populations.
5. How Safe Is Clinical Research? Clinical research is as safe as it can be. Clinical researchers take patient safety very seriously and adhere to strict safety protocols when administering drugs or treatments. Clinical trials are closely monitored, and every institute that conducts clinical trials must have an independent review board (IRB) overseeing the trial. The IRB ensures that all safety protocols are being followed, and if necessary can intervene to make changes or to end a trial.
6. When Will I See Results From My Clinical Trial? The research process doesn’t cease when the study activities have been completed! All data must be examined to discern any patterns that could provide responses to the questions posed by your investigation. In other words, there’s no exact answer to this as it’s dependent on the clinical trial phase, data analysis, and the processes of regulatory authorities. Clinical trials typically take several years from start to finish, so expect to wait a considerable amount of time.
If you are located in Oklahoma, and are interested in clinical trial enrollment, please take a look at our clinical trial open listings here. If you have any questions about them or enrollment in general, please contact us at 405-447-8839 or send us a message at the Lynn Health Science Institute.