{"id":18194,"date":"2019-05-01T16:00:43","date_gmt":"2019-05-01T21:00:43","guid":{"rendered":"http:\/\/thepapergown.zocdoc.com\/?p=18194"},"modified":"2026-02-05T07:46:38","modified_gmt":"2026-02-05T12:46:38","slug":"what-to-know-before-joining-a-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.zocdoc.com\/blog\/guides\/what-to-know-before-joining-a-clinical-trial\/","title":{"rendered":"What to Know Before Joining a Clinical Trial"},"content":{"rendered":"

When Joe O\u2019Connor was diagnosed with Parkinson\u2019s disease, he left his job in computer software to go on disability. The Social Security representative he worked with was compassionate, and made the process seamless.<\/span><\/p>\n

\u201cIt made me want to give back,\u201d O\u2019Connor says. The experience made him realize he had more to do. So O\u2019Connor, a Massachusetts native, decided to sign up for a clinical trial. He hoped that by volunteering to participate in a medical study, he could play a small part in helping to get new Parkinson\u2019s treatments and therapies on the market.<\/span><\/p>\n

Over the last few years, O\u2019Connor has participated in 17 trials. For one of them, he donned a rubber cap to test a device that Parkinson\u2019s patients could use instead of surgery to alleviate symptoms. In another trial, he said nonsense words with an endoscope shoved down his throat to test his vocal cords. He also spent 36 hours in near darkness while researchers studied how people with Parkinson\u2019s handle interrupted sleep.<\/span><\/p>\n

\u201cI\u2019m fascinated by the technology,\u201d O\u2019Connor says. \u201cIt\u2019s cool to be on the cutting edge of this stuff. I love it.\u201d Participating in trials has also given him insight into his condition. He was worried about losing his vocal cord function, as many Parkinson\u2019s patients do. After his endoscopy, the researcher reassured him that wasn\u2019t happening anytime soon.<\/span><\/p>\n

“When you get your prescription at the pharmacy, it\u2019s because someone participated in a clinical trial.”<\/p><\/blockquote>\n

O\u2019Connor is one of <\/span>thousands of patients<\/span><\/a> who enroll in clinical trials every year. <\/span>Some patients with terminal conditions turn to trials when they\u2019ve run out of treatment options. Others, like O\u2019Connor, simply want to learn more about their own disease and help further science.<\/span><\/p>\n

\u201c<\/span>When you get your prescription at the pharmacy, it\u2019s because someone participated in a clinical trial,\u201d says Brandy Starks, who founded the <\/span>Clinical Trials in Color Foundation. <\/span><\/p>\n

Starks,<\/span> who previously worked as a <\/span>clinical research coordinator and manager, started her own nonprofit to advocate for people of color in clinical trials. \u201cOne reason to participate is <\/span>altruistic,\u201d she says. \u201cPeople want to contribute with the hope they\u2019ll help people down the line.\u201d <\/span><\/p>\n

If<\/span><\/a> you\u2019re thinking about participating in a clinical trial, here\u2019s what you should know.<\/span><\/p>\n

What exactly is a clinical trial?<\/h3>\n

Clinical trials are one type of medical research. They gather data on the safety and effectiveness of new drugs and therapeutic devices. They can be funded by government agencies, such as the <\/span>National Institutes of Health or the Department of Veterans Affairs,<\/span> medical institutions, foundations and <\/span>biotech or<\/span> pharmaceutical companies.<\/span> A drug or medical device must go through several trials before it\u2019s sold to consumers. <\/span><\/p>\n

\u201cThe <\/span>ultimate goal is to gather information and have a better understanding of the disease process or treatment effect so we can help others,\u201d says Dr. David <\/span>Schopfer, a cardiologist and health services researcher at the San Francisco VA Healthcare System.<\/span><\/p>\n

Drugs and devices typically have to go through four phases of clinical trials and get approval from the FDA before they can come to market. The FDA also needs to approve any trial before it can begin. Any study run out of a medical center will also need to secure approval from the facility\u2019s Institutional Review Board, which protects patients\u2019 rights. <\/span><\/p>\n

What are the different types of trials?<\/h3>\n

Phase I<\/b>\u00a0trials assess how safe a drug or device is. They usually include a small number of volunteers and take several months to complete. <\/span><\/p>\n

Phase II<\/b>\u00a0studies test how effective a drug or device is. They might include several hundred participants and last from several months to a few years. Most are randomized, meaning one group of participants gets the drug being tested, while a control group gets a placebo or standard treatment. These studies are also often double blinded. That means neither participants nor researchers know who gets the experimental drug. Setting up an experiment this way minimizes the chance of biased results, making randomized double-blind studies the \u201cgold standard\u201d study design. <\/span><\/p>\n

Phase III<\/b>\u00a0studies provide more details on a treatment\u2019s benefits and possible side effects. They can include up to several thousand patients and last several years. <\/span><\/p>\n

Phase IV<\/b>\u00a0studies happen after a drug or device has been approved for sale. They might look at the treatment\u2019s long-term effectiveness or compare it to other options on the market.<\/span><\/p>\n

How do I find a clinical trial?<\/h3>\n

Ongoing and completed FDA-regulated research studies in the U.S. and abroad are listed on <\/span>clinicaltrials.gov<\/span><\/a>, a website run by the NIH. You can search for trials by condition, location or type. <\/span><\/p>\n

Starks, who\u2019s written entries for the website, says it\u2019s not perfect: \u201cThe language can be quite technical, but it can be a good starting place.\u201d<\/span><\/p>\n

You can also contact major medical centers in your area to see what studies they\u2019re running, or consult foundations like the <\/span>Arthritis Foundation<\/span><\/a>, which may have their own, more user-friendly search databases.<\/span> You might also ask your doctor if they\u2019re aware of current trials, or sign up for a national research volunteer registry like <\/span>ResearchMatch<\/span><\/a>.<\/span><\/p>\n

It\u2019s important to remember that just because you agreed to participate and you signed the consent form, you\u2019re under no obligation to finish the study.<\/span><\/p><\/blockquote>\n

Tami Kamin Meyer, a patient in Columbus, Ohio, found out about the arthritis study she\u2019s currently participating in through an e-newsletter from her local community center. Thanks to arthritis in her left knee, Meyer had to forgo activities she loves, like tennis, and needs surgery. Her 55th birthday was a turning point: \u201cI decided to make it a monumental year, to change things in my life completely.\u201d <\/span><\/p>\n

When she saw the study blurb, she wanted in. Since the study began, she\u2019s lost weight and become more active, which will ultimately make surgery easier, she says.<\/span><\/p>\n

How do I sign up?<\/h3>\n

Your first step after you find a trial is to email or call the research coordinator to express interest. Researchers often look for participants with specific characteristics. <\/span><\/p>\n

You\u2019ll be asked questions about your condition, your age and other variables, either over the phone or in a written or online survey, to determine whether you qualify. Several weeks might pass before you find out if you\u2019ve been selected.<\/span><\/p>\n

Before accepting, \u201c<\/span>ask a lot of questions,\u201d says <\/span>Schopfer. For example, how might the study help you? Starks says to know exactly what\u2019s involved. A trial involving multiple blood draws, for instance,\u00a0 might not be a great fit if you\u2019re petrified of needles.<\/span><\/p>\n

Also, if you\u2019re considering a later-phase clinical trial, Starks recommends reading up on the drug being investigated to see if you\u2019re comfortable with the possible side effects, and asking about the number of visits required for participation to see if your schedule can accommodate the commitment. \u00a0<\/span><\/p>\n

What should I expect if I volunteer?<\/h3>\n

Before a study starts, research participants have to sign a form called the informed consent, which outlines the study and participant obligations.\u00a0<\/span><\/p>\n

The form will talk about compensation; most studies pay a modest amount for participants\u2019 time and might provide reimbursement for expenses like gas and parking. You might also receive a gift card for your time instead of cash. Read the form carefully and ask questions about anything you don\u2019t understand. <\/span><\/p>\n

In most studies, you\u2019ll be randomly assigned to a group, and you won\u2019t know if you\u2019re receiving the experimental treatment or getting a placebo. Your obligations depend on the specific study, but might include having your vital signs taken, getting bloodwork done or filling out questionnaires. Some studies will require periodic visits to a medical center, while others might involve virtual visits instead. A study could last anywhere from a few days to several years. <\/span><\/p>\n

Are there potential drawbacks to participation?<\/h3>\n

Because trials deal with experimental drugs, you might experience side effects during the study, see no change in your condition or even see symptoms temporarily get worse. <\/span>It\u2019s important to remember that just because you agreed to participate and you signed the consent form, you\u2019re under no obligation to finish the study. <\/span><\/p>\n

\u201cYou can stop at any time, and there won\u2019t be any negative consequences,\u201d says Starks.<\/span><\/p>\n

Why is it important for more people to volunteer?<\/h3>\n

Many clinical trials end prematurely because they can\u2019t find enough volunteers. That means potentially helpful treatments take longer to come to market.<\/span><\/p>\n

Older patients, people of color and women have historically been underrepresented in clinical trials. It\u2019s hard for physicians to effectively prescribe treatments when there\u2019s a lack of data on how the drug performs in these groups. \u201c<\/span>There\u2019s a predominance of middle-aged white men in trials,\u201d says <\/span>Schopfer<\/span>, \u201cbut our country is much more diverse.\u201d<\/span><\/p>\n

\n

Ready to book a doctor’s appointment? Visit Zocdoc.<\/span><\/a><\/span><\/h1>\n","protected":false},"excerpt":{"rendered":"

Every year, thousands of Americans join clinical trials to try new treatments or just do their part for science. <\/p>\n","protected":false},"author":41,"featured_media":18196,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[227],"tags":[159,132,160],"class_list":["post-18194","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-guides","tag-clinical-trials","tag-research","tag-volunteering","reviewer-dr-nassim-assefi"],"yoast_head":"\nWhat Should You Know Before Enrolling in a Clinical Trial?<\/title>\n<meta name=\"description\" content=\"Every year, thousands of Americans join clinical trials. 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