What Are Clinical Trials?

Clinical trials are research studies in which people help doctors find ways to improve health. Each study seeks to answer scientific questions and to find better ways to prevent, diagnose, or treat disease. Medical products, such as drugs, vaccines, and diagnostic tests, have to be studied in clinical trials before they can be approved for public use. A clinical trial follows a plan or “protocol” that is reviewed and approved before the trial can begin. This review ensures, among other things, that the trial follows appropriate safety guidelines.

What Happens in a Clinical Trial?

If you are interested in volunteering for a clinical trial, first find out if you are right for that trial and if the trial is right for you. Each trial has rules about who can volunteer. For example, you may have to weigh a certain amount, have certain blood tests, or be taking or not taking certain drugs. Depending on the needs of the trial, researchers may seek volunteers who are healthy or who are receiving care for a medical condition. Talk to your doctor to see if a clinical trial is right for you. If you fit the rules of the trial, all details, including risks, benefits, and requirements of participating in the trial, will be explained to you. You will then be asked to sign an informed consent form, which shows that you understand what the trial entails and that you are willing to participate.

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Coming Soon!!!

The National Black Church Initiative and the American Clinical Health Disparity Commission along with our forthcoming Chief Clinical Craz and our NBCI Clinical Trial Taskforce are in discussion to create multiple national disease-specific registries for both African-American and Latino patients so that we can provide critical up-to-date and science-based medical information and education to these individuals who are coping with diabetes, cardiovascular diseases, cancer, or other disease states.

Will You Still See Your Regular Doctor?

Yes, you will still be under the care of your regular doctor for your general health. You will see the study doctor or nurse for planned study visits.

Do You Have To Pay Anything?

There is no charge for study-related medical care, including study visits, medications, treatments, and procedures. Transportation and other costs may be provided.

How Long Is a Clinical Trial?

The length of each trial is different. Some last a few months and others last for several years. You are free to leave the trial at any time.

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A step-by-step guide to finding and participating in clinical trials

Here is a step-by-step process for finding and applying to clinical trials, from starting your search to enrolling in the right one for you or your loved one. While a patient's physician can refer them to a clinical trial, given the huge and ever-growing number of clinical trials available, it’s incredibly difficult for even the best and brightest doctors to stay up to date on all the possible treatment options. Oftentimes, they will be unaware of any trials being run outside of their institution.

Although patients and loved ones can look for options on their own, the process can be incredibly time-consuming and confusing -- the last thing patients need when dealing with a health issue. In this guide, you'll find everything you need to know about the process.

Here is a step-by-step process for finding and applying to clinical trials, from starting your search to enrolling in the right one for you:

1. Find all of the clinical trials are currently available for the condition

The most common way to see all the clinical trials that are accepting patients is to use a service that matches you with clinical trials.

Examples of different platforms

Major Clinical Trials websites is the official government resource that provides the public with information on publicly and privately supported clinical studies. Information on the website is provided and updated by the organization that is organizing the clinical study, and nearly all clinical trials are required to be posted on the site. Unfortunately, the language used to describe the studies is often written in a way that's difficult for individuals without a medical background to understand.

In certain conditions, there are trial finders dedicated to finding the available clinical trials for the condition specifically. These can be easier to use because the platform has tailored features for the disease. For example, the National Cancer Institute (NCI) has a platform to find studies that are specifically NCI-supported clinical trials, and the Alzheimer's Association has one as well. There are also pharmaceutical companies and other private organizations that have developed their own trial finders, but these will only show you studies that they are running, or being paid to recruit for.

It's important to know that in certain cases, the medical teams will specify a 'condition' that the treatment is targeting, but the condition is not listed in a way that matches how most patients are diagnosed. This is common with cancer, where a study might target "solid tumors" as the condition, which covers a broad range of cancers. Another example is Graves' disease, which is also called hyperthyroidism. So, it can be important to research what other terms a condition might be referred to in order to make sure you see all of your options.

2. Narrow down the studies by what's likely to be a good fit: Go through the requirements.

When designing a study, the research team specifies guidelines about what kind of patients the study is meant to help. These guidelines, often called ‘eligibility criteria’, are meant to ensure patient safety and meaningful results from the study. If you decide to look for a clinical trial, knowing certain details about your diagnosis can be helpful for comparing these criteria to find the studies that you can take part in.

Common eligibility criteria

Trials commonly include the following in their participation criteria:

  • Age
  • Sex
  • Diagnosed medical conditions and symptoms
  • Current and past treatments
  • Locating the guidelines

You can find a study’s inclusion and exclusion criteria through a study’s page on any platform that helps you find clinical trials. They should also be explained to you before you enroll in a trial. Occasionally, some trials will accept patients who are very close to meeting the eligibility criteria for the study (for example, if your age is a few months over the accepted age range), however, these will generally dictate exactly who can and cannot be accepted into the study

Going through the requirements

Eligibility criteria are separated into two types -- inclusion, which you’ll need to have, and exclusion, which you can’t have. For example, trials investigating a new drug for ovarian cancer may have, “females who are over the age of 20” as part of the inclusion criteria. Trials that treat diseases with multiple progressions, such as cancer, may only accept patients with a specific stage of disease or affected area in the body. An example of a common exclusion criteria is not allowing patients who have been on a medical treatment that interferes with the new one being provided by the study to participate.

Eligibility criteria can be difficult to understand - if you're not sure if you're qualified or not, don’t hesitate to reach out to the study team. They’ll be able to help break down any confusing inclusion or exclusion criteria. Also, feel free to reach out to a Clara team member with any questions regarding these criteria; we’re more than happy to get in contact with the medical teams to find the answer to any specific questions!

3. Reach out to the research teams for the studies you're interested in

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After you’ve found a study that you want to learn more about, the next step will usually involve contacting the study team for more information about the study, via email or phone.

To do this, you can contact the trial team directly, or ask your doctor or another member of your healthcare team to contact them for you. The clinical trial listing should include the phone number of a person or an office that you can contact for more information. If multiple numbers are given, it's usually best to contact the person whose title is "study coordinator", rather than the lead researcher (called the "protocol chair" or "principal investigator"). This person can answer questions from patients and their doctors. It is also the trial coordinator’s job to decide whether you are likely to be eligible to join the trial. However, a final decision will probably not be made until you have met with a doctor who is part of the trial team. Because the contact information listed is usually outdated or not a direct number, on the Clara Platform, we help interested patients reach out to the trial team so we can help connect you with the right party!

Once you connect with the study team, they'll typically start by asking you some basic questions to help determine if it looks like you’re a good match to participate, and be provided with some basic details about the study, such as how many visits are involved and if there is any compensation for costs.

The next step will usually be to schedule an in-person visit with the research team to go through the informed consent process. This will involve going over the trial in depth to make sure you understand all the details and what’s involved. Before enrolling, they will often review your medical history with you and go through all the different trials in their network to see if any of them may fit you better.

There are many things to consider when deciding whether or not to participate in a study. Study coordinators are a great resource during this stage of your decision-making process, as their role includes communicating with the rest of the study team to help answer any questions you may have before, during, and after a trial.

Tip: consider taking notes during your meeting, or even ask if you can record the conversation.

Below is a list of questions you may want to cover with the team to help you decide if the trial is a good fit for you.

Questions to ask the research team

General information

  1. What’s the goal of this study?
  2. Why do researchers believe the treatment being tested might be effective? Have there been other studies on it?
  3. Is there a possibility I will receive treatment other than the one being studied? If I am in the placebo group, will I be given the test treatment at the end of the trial?
  4. Where will I have to travel to for the study?
  5. How many visits are there? What will I be required to do at each visit?
  6. How long will the trial last? Will overnight stays be required? If so, how often?
  7. Who will oversee my medical care while I am participating in the trial?
  8. Will the results of the study be provided to me?

Financial questions

  1. Who will pay for the care required during the trial? Can someone on the team help me speak with my insurance company?
  2. If I don’t have insurance, can I still participate? Are there any other potential costs with participating even if I have insurance?
  3. Do I get any form of compensation for participation?
  4. If so, how often will I be paid? What is the method of payment?
  5. Are any types of reimbursements offered (travel costs, lodging, food, etc.)?

Treatment logistics

  1. Can I take my regular medications while I am in the study?
  2. Can I access the treatment after the study finishes? How?

4. Choose which trial you want to enroll in

Finally, there are important conversations to prepare for. If you end up with more than one study that you're eligible for and may want to participate in, the last step is to choose which trial you want to enroll in.

After speaking with the study teams, you may want to talk to your family, primary care physician, and an additional source for a second opinion before choosing which to enroll in. In almost all cases, you cannot be enrolled in more than one study at the same time.

There are many factors that go into finding the right clinical trial, and the details can sometimes be overwhelming. You should never feel compelled to make a decision until you have learned everything you can about your condition, prognosis, and each available treatment option.

Tip: Getting a well-rounded perspective from a few sources on the potential trials can help you feel confident about your choice.

The next sections explore major areas to consider when you're trying to decide which study to enroll in.

Comparing the study designs

After speaking with the study coordinator and receiving your informed consent form to review, you can begin comparing the different features of each study. Things to consider include:

  • The goal of the study
  • Past collected data on the new treatment, and what phase of testing it’s currently in
  • If you can access the treatment after the study ends
  • The chances of receiving a treatment that is not the one being studied (such as a placebo, or another FDA-approved treatment)

Thinking about time and costs

Take into account the location you have to travel to, the amount of reimbursement and payment given to participants, and the duration of the trial to gauge how participating in the study will impact your life.

The number and time required for each visit will greatly impact the amount of effort and expenses of each trial. Depending on how far you need to travel, you might need to consider the cost of housing and the potential for lost income due to time spent away from work.

Reviewing with your doctor

Talk to your physician before making your decision. They know your medical history and could offer information you weren’t aware of or hadn’t fully considered. Unfortunately, physicians cannot be paid by insurance companies for time spent researching or discussing potential trials with patients, so they might not be able to take the time to go over the options. Still, it’s best to ask and start the conversation.

If they do take the time to review the studies with you, it’s important to keep in mind that your doctor likely doesn't know all the details about a given study and may not be able to answer all of your questions. This is especially true if it's not being run at their hospital, and due to this, they may be biased towards recommending only the ones from their institution. Keep a record of any questions you have that your doctor can’t answer because the study team or another medical specialist should be able to provide more information.

Getting a second opinion

When making a major medical decision, it’s natural to be curious about what different medical teams would recommend. Getting a second opinion is an effective way to make a fully informed decision. Some insurance companies may even require that you receive a second opinion before you begin treatment.

Reasons why you may want to find a second opinion

  • Your doctor is not a specialist in your condition
  • Your doctor is only willing to discuss options from their hospital
  • You’re having trouble communicating with your doctor
  • You want peace of mind that you are making the right choice
  • When looking for a second opinion, you should contact your insurance company to confirm what your policy covers.

Who to look for to get a second opinion

Although the trial’s study team will be the most knowledgeable about the study itself, it is ideal to find an individual who can re-evaluate all of your options. Your current healthcare team or insurance provider can guide you to specialists in your network who can give you a second opinion on potential clinical trials.

As you look for your second opinion, it is essential to find someone who is very experienced with treating your condition, and if possible, is also familiar with the clinical trial you are interested in even though they're not part of the study team.

Here are two ways to open a conversation about a second opinion:

  1. “Before I choose a treatment option, I’d like to receive a second opinion. Could you help me with that?”
  2. “If you had this diagnosis, who would you want to see for a second opinion?”

What to have ready for a second opinion visit

Come prepared with exact details about your condition and treatment to get the most of your second opinion. You can even ask your hospital’s medical records departments for copies of your records. You may want to bring:

  • A copy of your operative report for any surgeries you've had
  • If you were in the hospital, a copy of your discharge summary
  • A summary of your doctor’s current treatment plan
  • A list of all medications, including the doses, and dates last taken

Seeking the advice of more than one specialist can provide an additional evaluation of your treatment options, as well as help you gain confidence in your healthcare decisions.

Speaking with your Pastor and loved ones

Participating in a clinical trial can be physically and emotionally challenging, especially when already dealing with a medical condition. The best way to ensure a healthy and safe experience is by including your loved ones in the study process; the support and insight they can provide will prove invaluable to a positive trial experience.

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5) Find a Sickle cell Clinical trial

The Sickle Cell Clinical Trial Finder is now available as a mobile app! Download it from the Apple or Android app store today!

SCDAA, 8 pharma companies team up to increase trial participation

The Sickle Cell Disease Association of America (SCDAA) is collaborating with several pharmaceutical companies in a new initiative aimed at increasing awareness of the blood disorder and promoting clinical trial participation.

Welcome to the Sickle Cell Disease Association of America’s Clinical Trial Finder, created in partnership with Forma Therapeutics. Our Clinical Trial Finder is a centralized, simple-to-navigate resource that helps people with sickle cell disease, their families, and caregivers find clinical trials. Clinical trials help pharmaceutical companies and researchers develop new sickle cell treatments. Your participation helps guide these breakthroughs and also gives you access to these new treatments before they are available to the public. Click here to learn more about clinical trials and why they are important. Use the tool below to search for trials by keyword, location, study type, and phase – now listed in one place.

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