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Clinical trials are a way to access cutting edge medical treatments.  Today's standard treatments are yesterday's clinical trials.

A clinical trial is a carefully controlled study to answer specific questions about a new drug or treatment, a new way of using an old drug or treatment or a new diagnostic tool. It is a myth to think that people who participate in clinical trials are used as "guinea pigs."  Trials are not conducted until scientists and researchers have done a great deal of research in the laboratory and possibly on animals.  All clinical trials are required to follow federal regulations which includes a jprovision that each study must be subject to an institutional review board (IRB) which reviews and monitors the study.

Advantages of clinical trials: Clinical trials can be particularly useful for people who are not able to find a cure or symptom relief with standard treatments. In addition:

  • Participants have the advantage of getting access to a drug years before other patients. This can be particularly useful if the drug being investigated is successful. .
  • Participants have a team of doctors looking at their situation rather than just one.
  • Participants know that other people are being helped because of their participation. This is especially if the trial is successful. It is even true if the trial isn't successful. 

Clinical trials are conducted in three phases.

  • Phase I trial: The purpose is to determine the safety of the treatment for humans and the best way to administer the treatment.
  • Phase II trial: Doctors study the effectiveness of a treatment.
  • Phase III trial: 
    • A control group of patients receives the standard treatment. Another group in the trial receives the new treatment. This technique permits doctors to compare the effectiveness of the two treatments. 
    • Side effects are monitored. If the side effects are too severe, the trial is discontinued.

You can find a clinical trial through a variety of ways, including seaching online.

If you are considering joining a clinical trial, it is advisable to start looking for a trial as soon as possible to maximize your chances of qualifying. Qualifying rules vary from trial to trial. Some trials only take people who have not been treated at all. Others require specific prior treatments etc.  

Before joining a clinical trial, take whatever time you need to absorb all of the information about the pros and cons of joining the trial. Get expert avice. For example from your specialist or primary care physician. Consider:

  • Whether your best interests would be served by participating in the clinical trial.
  • The outcome the researchers are looking for.
  • The potential reward.
  • The potential risks. 
  • Safeguards that are built in to the clinical trial to protect a participant's medical and psychological health.
  • Whether you are liable to pay any costs. Research costs are covered by the trial. If there are additional costs, they are covered by private health insurance, Medicare and Medicaid. If you are uninsured, you can negotiate costs. (For information about how to negotiata medical bill, including professionals who can help if needed, click here.)
  • How much of your time and effort is required. A trial may also require that you stop taking other medications.
  • There is no right to continue to have access to the drug after the trial is over. You may be able to continue to get the drug through "compassionate use." To assure a drug's continued availability, get agreement from the trial sponsors before entering the trial.

You can leave a clinical trial at any time, for any reason. 

Sometimes trials pay people to participate. It is advisable to ake the decision about whether to join a trial based on the possible benefits to your health, not for the money.

Your doctor's approval or referral is not necessary to allow you to enter a clinical trial. However, it is advisable to discuss with your doctor whether to join a particular clinical trial. Your doctor may be able to provide valuable insight and advice. Your doctor should also know about all drugs you are taking. If he or she advises against a particular trial, ask why. 

If you are thinking about joining a clinical trial conducted by your own doctor at his or her suggestion, consider seeking a second opinion from another doctor who is not connected with your doctor. A second opinion helps assure that the suggestion you enter the trial is because of your interests rather than your doctor's. For information about obtaining a second opinion, click here.

For additional information, please see:


  • Many patients are concerned about joining a trial because they do not want to receive a placebo. Basically, a placebo is a pill that looks like the real pill, but is a dumy instead. Trials for serious health conditions tend to compare a new drug against the most effective current treatment. So, while participants in trials which include a comparison do not know what they receive, at the least it is the most effective current treatment.
  • If you cannot obtain a drug through a clinical trial, you may be able to obtain it through Compassionate Access or by purchasing it abroad.s
  • If you have health insurance, thanks to the Affordable Care Act (sometimes referred to as "Obamacare"), insurers are prohibited from taking away or limiting coverage when an insured individual decides to participate in a clinical trial.

Clinical Trial Phases

There are four phases of Clinical Trials, plus "IND Exempt Clinical Trials."  Each phase has different purposes and entails different levels of risks for participants.

The phases, which are discussed in other sections of this document, are:

Phase I Clinical Trial

  • In General: A Phase I cinical trial is the most experimental phase of clinical trials. Previously, the drug has not been testsed in humans.
  • Purpose: The primary purpose of a Phase I trial is to evaluate the safety of a new drug or treatment. A Phase I trial seeks to determine:
    • An initial dosage range.
    • The best method of administration (oral, injection).
    • Possible side effects.
  • There are generally no conclusions about how well a drug works in Phase I trials.
  • Number Of Participants: In Phase I trials, researchers generally administer the new treatment to a small group of people, usually 10-80 participants.
  • What Happens For drug studies, the researchers generally begin by providing a very lose dose. The dosage level is slowly increased as new patients enter the trial.
  • Monitoring For Side Effects 
    • Patients are carefully monitored for harmful side effects. Although the treatments have been well tested in the lab prior to the trial, there may still be significant risk.
    • Because the treatment being studied is new, researchers don't always know the expected side effects. Side effects or adverse reactions may include headache, nausea, hair loss, and skin irritation, among others. In some rare cases the side effects may be serious or even life threatening.
    • Many side effects are only temporary and go away when the treatment is completed or stopped. Other side effects can be permanent. For this reason, some phase I trials may be limited to patients whose condition cannot be helped by other known or proven treatments.
  • Duration Phase I trials generally last for several months.
  • Conclusion:  If the drug or treatment appears to be safe, it moves to Phase II. Approximately 70% of drugs or treatments tested in Phase I trials proceed to the next phase.

Phase II Clinical Trial

  • Purpose The primary purpose of a Phase II trial is to determine the effectiveness of a treatment and to further evaluate its safety.
  • Number of Participants The treatment is administered to a larger group, usually 100-300 patients, who are closely monitored for treatment response and side effects.
  • Duration Phase II trials may last from several months to 2 years.
  • Conclusion If a significant number of patients (usually at least one-fifth) respond favorably to a treatment, it proceeds to Phase III. Approximately 33% of drugs and treatments proceed to the next phase.

Phase III Clinical Trial

  • Purpose The primary purposes of a Phase III trial are to: 
    • Confirm the effectiveness of a drug or treatment
    • Test the safety of the drug or treatment
    • Determine the most effective dosage levels.
  • Phase III studies look for a treatment that will provide a longer life expectancy, better quality of life, fewer side effects, and/or a lowered chance of the condition returning.
  • Number of Participants This larger trial group may include 300-5,000 people or more.
  • What Happens  
    • Phase III compares standard (proven) drugs or treatments or placebos (no treatment) with the drugs or treatments that appeared to be effective in the Phase II studies. The people who participate are divided into those receiving the standard treatment or placebo, and those receiving the experimental treatment. The responses of the groups are then compared.
    • If during the trial it is determined that one treatment is superior to another, the trial may be stopped. If that is the case, all participants are given the more effective treatment.
  • Duration Phase III trials may range in length from 1-4 years. Approximately 25-30% of drugs and treatments will clear this phase. According to the FDA, about 20% of drugs and treatments that are tested in people will ultimately be approved for marketing.

Phase IV Clinical Trial

Phase IV studies are done after a drug or treatment has been approved by the FDA and marketed. These studies continue testing a drug or other treatment to collect information about their effect in various populations, changes in how a treatment is administered, and any side effects associated with long-term use. There may also be studies comparing a drug with other drugs. 

IND Exempt Clinical Trials

“IND Exempt Clinical Trials” are a slight variation on approved drugs. For example, the trial tests a change in scheduling or dosage. These trials are not really Phase IV, but are similar.

IND Exempt Clinical Trials are usually initiated by an investigator, not a pharmaceutical company.

The FDA doesn’t review these trials. It sets the criteria for IND Exempt Clinical Trials in regulations. If a trial wants to go outside the regulations, it requires FDA review.

The Institutional Review Board (IRB)

An Institutional Review Board (commonly referred to as an "IRB") protects the rights and welfare of people who participate in a clinical trial.

To accomplish this mission, IRBs ensure that the

  • Physical, psychological and social risks participants in the trial are minimized. If risks are present, the IRB makes sure they are justified by the importance of the research and/or the knowledge to be gained from such research.
  • Potential and participating subjects are adequately and appropriately informed of the nature of the research, the risks involved and their rights as research subjects.

Regulations of the Food and Drug Administration offsite link (FDA) and Department of Health and Human Services offsite link (specifically Office for Human Research Protections offsite link) empower IRBs to approve or disapprove research, or to require modifications in planned research prior to approval.

IRBs are usually composed of at least five members.IRBs are composed of medical professionals and researchers, as well as at least one community member who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. 

Members must have enough experience, expertise, and diversity to make an informed decision about the following subjects:

  • That the research is ethical
  • That informed consent is sufficient
  • Appropriate safeguards have been put in place to protect people who participate. 


The Interview Before You Agree To A Clinical Trial

Your interview with the research team in charge of the clinical trial provides a great opportunity to learn more about the treatment being studied, the potential benefits and the risks.  During the interview, you may speak with the trial coordinator, doctor, research scientist, nurse, or other member of the research team. 

Knowing the right questions to ask, and understanding the responses, can help ensure that you choose the trial that may be most beneficial. It is also helpful to have someone with you at the interview to help ask questions and remember answers. If the researchers allow it, record the interview so you can review the discussion in the quiet of your home.

How To Prepare For An Interview About Joining A Clinical Trial

In order to make the most of your interview time with the trial coordinator, consider the following.

Plan the questions that you may wish to ask. You can write down a list of questions or print the suggested questions that you will find at: A List Of Suggested Questions To Take To The Clinical Trial Interview.

Preferably, do not go alone. Take a trusted friend or loved one with you to the interview. He or she can help ask questions you don't think about or may be too embarrassed to ask. You will also have someone to discuss what you heard. 

The person to go with you should be someone who can:

  • Provide emotional support
  • Ask questions that you don't think of or are too embarrassed to ask
  • Help you understand the responses
  • Review what was said with you after the meeting

It is also advisable to take a recorder - even if you plan to take written notes. (If your mobile phone doesn't record, recorders are not expensive.) A great deal of important information is likely to be exchanged during the interview. Recording will allow you to review the information later in a more relaxed environment. A recording also provides an easy way to share information with friends and family.

At The interview For A Clinical Trial

During the interview process, expect to receive an Informed Consent document as well as an explanation about the trial.

Take as much time as you need to ask questions when discussing the details of the trial. It is the responsibility of the trial coordinator (or whoever is conducting the interview) to provide thorough information, and to address all of your questions and concerns.

Find out who to call, when and at what number in case you think of additional questions after the interview. Do not hesitate to call the trial coordinator, or schedule another interview.

Be certain that you understand exactly what you are being told during the interview. If you are unsure about a response, repeat back to the trial coordinator what you thought was said. Ask if your understanding is correct. You may also choose to rephrase your question, or ask the coordinator to repeat what was said in a different way. Visuals can also assist with understanding. If necessary, ask the coordinator to provide or draw a diagram.

Ask for a copy of the protocol. The protocol is a document prepared by the sponsor of the trial describing the trial details. It is more detailed than the Informed Consent Form. For instance, the protocol may provide the results of previous animal tests and human trials, as well as the number of people expected to enroll. You may also learn additional information about possible side effects.

Find out if your doctor is one of the principal investigators in the trial. The more closely connected the doctor is to the conduct of the trial, the more information she will have. If you have a bad side effect, it may be recognized sooner than by a person not as closely connected to the conduct of the trial. If your doctor is not a principal investigator, find out who is and how to get hold of that person.

Ask the research team if you can speak with other trial participants. It will give you an opportunity to ask other people about their personal experiences (both good and bad) associated with the trial and treatment. If applicable, you may also want to speak with people who have completed treatment.

To Learn More

What Protections For Participants Are Built Into Clinical Trials?

There are strict guidelines and safeguards that are designed to protect everyone who participates in clinical trials. They include the following:

  • FDA guidelines
    • The FDA reviews and approves the overview and the details of the guidelines to be used in a clinical trial before any clinical trial can start.
  • Institutional Review Boards (known as IRBs)
    • Most clinical trial in the U.S. must be approved and periodically monitored by an IRB.  The IRB is an independent board composed of research scientists, doctors, and local community members. 
    • It is the job of the IRB to insure that clinical trials are conducted in an ethical manner and that the rights of study participants are protected. This includes insuring that risks are minimized as much as possible and that the possible benefits outweigh the known risks.
  • Data Monitoring Committees
    • Data Monitoring Committees are primarily used for studies comparing one treatment with another and in cases where treatments are selected for patients at random. The participation of the committee is especially important for treatments geared toward very serious illness.
    • Information is reviewed to ensure that treatment study is performed as safely as possible for the trial volunteers. If the committee determines that a treatment is harmful or ineffective, the study will be discontinued.  Likewise, if it is determined that one treatment is more effective, the committee will halt the study and all volunteers will be provided with the more beneficial treatment.
  • FDA Periodic Inspections
    • In order to protect volunteers and confirm that studies are being conducted correctly, the FDA periodically inspects clinical trial records as well as the research scientists and facilities conducting the trial.
    • Inspections may also be conducted in response to filed complaints.

To Learn More

How To Locate A Clinical Trial

There is no single place that lists every clinical trial. However, between your doctors, the internet and other resources available to you, the odds are that you can learn about clinical trials that may be right for you. 

Two tips before you start your search:

  • It is advisable to create a list of the details of your diagnosis and treatments to date before looking for trials for which you qualify. It will help you save time. To learn how, click here.
  • Start your search with studies listed as Phase III, late-stage, large tests on the drug's safety and efficacy. If you do not find what you're looking for, search for other Phase III trials, then Phase II, then Phase I.  (For information about clinical trial phases, click here.)

Following is a list of sources that can help you find an appropriate clinical trial:

  • Your Doctor(s) (a good first step)
    • Your doctors' participation, opinion, and advice, can be invaluable with the selection of an appropriate trial.
    • Your doctors are also a good starting point for finding a trial that fits your diagnosis and specific needs.
    • You may still need to do your own research. There are far too many trials for most doctors to be familiar with all of them. At the very least, a doctor should be able to provide information about trials conducted by colleagues and/or the hospital with which she is affiliated.
  • The Internet (the standard second step)
    • Following is a list of some well respected sites to consider. For specific health conditions, see below:.
      • National Institutes of Health (NIH) has two services:
        • offsite link for patients who wish to participate in clinical trials in designated National Cancer Institute cancer centers. 
        • offsite link. (Tel.: 800.411.1222)   This service is sponsored by the National Institutes of Health (NIH), through the National Library of Medicine.  The service has a current listing of more than 4,000 studies, allowing access to information about virtually all government clinical trials sponsored by the various divisions of the NIH.  In addition, the site provides listings and information on trials sponsored by other federal agencies, the medical industry (including pharmaceutical companies), university and healthcare organizations.  You can search by condition, location, treatment or sponsor.
      • offsite link : 
        • A for profit site which matches patients' personal profiles (including disease stage and prior treatments) to enrollment criteria for trials on a computer generated basis.  
        • There is no fee to you, the patient. EmergingMed gets paid through the fees it charges research sponsors and others. 
        • Consultants call patients who have registered with the service when a new trial comes up. 
      • offsite link: a for profit site that searches through 25,000 industry and government sponsored trials.
      • offsite link : searches multiple web sites for listings
    • If you look for a clinical trial on an internet site not listed here, consider the following:
      • The sponsor of the site.
      • The source of funding for the site.
      • Who manages and edits the site.
      • The privacy policy of the site
  • Local hospitals
    • Many hospitals and/or their admitting physicians participate in clinical trials. You may first choose to call local teaching hospitals or those hospitals containing units that specialize in the treatment of your condition.
  • Medical schools
    • Many medical schools participate in clinical trials. They may also provide information about trials that are being conducted by associates.        
  • Disease specific non-profit organizations
  • Support groups
    • Support groups and self help groups are a great source for information about local trials. In addition, you may be able obtain valuable first hand information from those who are participating in or who have completed a trial that may be of interest to you.  
    • You may also obtain information from a cancer buddy (yet another reason to have one).
    • To learn about support groups, self help groups and cancer buddies, see: Support GroupsSelf Help Groups, Buddies
  • Food and Drug Administration (FDA)
    • For questions or general information regarding clinical trials call 888-INFO-FDA (888.463.6332), or the FDA's Office of Special Health Issues at 301.827.4460. To locate FDA approved clinical trials see offsite link.
  • National Institutes of Health
    • For information about complementary medicine trials call the NIH National Center for Complementary and Alternative Medicine, at 888.644.6226 or offsite link.
  • Drug/Pharmaceutical Companies
    • The drug companies sponsor many of their own FDA approved clinical trials. You can contact these companies directly for more information. For a listing of pharmaceutical company sponsored trials see , offsite link under the heading "industry."
    • Also look at offsite link -- the site of the International Federation of Pharmaceutical Manufacturers & Associations. You can also find a complete listing of drug companies and their telephone numbers in the Physicians' Desk Reference, available in most libraries, medical-book stores, and your doctor's office. Your pharmacist may also provide you with contact information.
    • Pharmaceutical companies also set up their own web sites to disclose results of their clinical trials. For example: Eli Lilly & Co., offsite link; GlaxoSmithKline PLC offsite link.
  • Cancer trials.  
    • The American Cancer Society: offsite link or call  800.303.5691
    • National Cancer Institute (NCI): trials or call 800.422.6237
    • offsite link: created by a coalition of cancer cooperative groups
    • The Cancer Information Service which is sponsored by the National Cancer Institute. Call 800.4.CANCER or go to offsite link
    • The U.S. National Library of Medicine database at offsite link
    • CenterWatch, a publisher that specializes in clinical trials. CenterWatch includes a free e-mail service that alerts you of new trials for which you may be offsite link
    • TrialCheck: offsite link
    • Colorectal Cancer: offsite link: a website of the Jay Monahan Center for Gastrointestinal Health.
  • HIV/AIDS Trials   To locate trials, or obtain information about FDA approved government and privately funded studies, contact:
    • The AIDS Clinical Trial Information Service (sponsored by the U.S. Department Of Health and Human Services) at 800.874.2572.
    • National HIV/AIDS Treatment Hotline at 800. 822.7422
    • The U.S. National Library of Medicine database at offsite link

If research is difficult for you, ask a friend or family member to do it for you. Or you can hire a professional.

To Learn More

How To Choose A Clinical Trial When More Than One Is Available

If more than one clinical trial appears to be available for your situation, check the eligibility details of each trial to be sure you are indeed eligible. For instance, even if your health situation fits the trial requirements, you may not be eligible because of treatments you already tried.

Once you are sure that you are eligible for more than one trial, to help make a decision:

  • Speak with your health care team. Ask their opinion about:
    • The pros and cons of each trial
    • Which he or she would recommend, and 
    • Why.
  • If there is still any question about which trial is best for you, get a second opinion from another specialist who has experience with your particular health condition. If necessary, get the opinion from a doctor who is not near where you live. You may not have to travel to the doctor. It may be enough to send medical records and speak on the phone.
  • Check with the disease specific non-profit that advocates on behalf of patients. A person may be available to speak with you or chat with you on line one-on-one. 


Questions To Ask Before Agreeing To Join A Clinical Trial

Once you have identified a trial that could work for you, you can interview the trial coordinator, doctor, research scientist, nurse, or other member of the research team.

  • The interview provides a great opportunity to ask questions including:
    • The potential benefits of the trial 
    • The risks 
    • Participant protections 
    • Costs you have to bear. (If you have health insurance, thanks to the Affordable Care Act (also referred to as "Obamacare"), the costs have to be paid for by your health insurance. Patient costs of clinical trials are also covered by Medicare.)
  • Knowing the right questions to ask, and understanding the responses, can help ensure that you choose the trial that may be most beneficial. 
    • Our Clinical Trial Interview chart contains a list of suggested questions to ask about a clinical trial in which you're interested. The questions have been divided into four separate categories.
    • You can prioritize the questions in their order of importance to you.  Just type a number next to each question which indicates your order of priority. Then click "Renumber " at the end and the questions will automatically be reordered to your preference. (If the order still doesn't fit your needs after clicking on "Renumber," you can keep redoing the chart until you're satisfied.)
    • Feel free to print the questions and take them with you to interviews about the trial.
    • You should be able to find the answers to most questions from the doctor who oversees the trial, the Informed Consent and/or the trial protocol. If the questions relate to how a trial will affect your daily life, speak with one of the trial's nurses.
    • Click here for your copy of The Clinical Trial Interview: A List Of Suggested Questions.

NOTE: Be sure all your questions are answered to your satisfaction before joining any clinical trial.

How To Get Access To A Drug After A Clinical Trial Is Over

If a drug works for you, you will naturally want to continue it after the trial is over. It is up to the manufacturer whether to continue to provide access to the drug as a "compassionate use." There is no legal right to continue to receive a drug after a clinical trial is over.

The best way to assure access is by building it in to the protocol for the trial, or you can request a binding agreement with the manufacturer before entering the trial.

To Learn More

Purchasing A Drug From Outside The United States

If a drug you are interested in is only available outside of the United States, you may travel to a foreign country to be treated, or you can obtain the medications by mail.

Keep in mind that drugs purchased abroad have not been subjected to the rigorous standards of the FDA. Be particularly cautious. If the drug is still being studied in the country of origin, look at the patient safeguards used in the trial. After you've done your research, share what you find with your doctor and get his or her opinion before saying "yes."

There are no limits on American citizens who leave the country for treatment. 

If you want to have the drugs shipped to you in the United States, keep in mind that it is not legal to import drugs that have not been approved by the FDA. While you should check the current FDA guidelines before making a purchase, the FDA guidelines permit small quantities such as an up to three month supply for one person when the drug will be used under the supervision of a licensed doctor for a serious condition for which no other effective treatment is available. Note that the FDA guidlines are only suggestions. A particular inspector may not permit the drug to be imported.

If you have health insurance, check it to find out if any of the costs associated with a drug purchased outside the U.S. are covered. Don't be surprised if they are not.

Clinical Trials: Emotions And Feelings

An emotion that commonly appears with clinical trials is fear - particuarly fear of being treated less well than standard treatments and being treated like a guinea pig. In fact, the reverse is true because of all the preparation and review that goes into creating a clinical trial, watching for side effects, and observing response to the drug in question.

In addition, many trials monitor data known as "health-realted quality of life" which involves the quality of life a person experiences on the drug (in addition to the physical effects).

Another feeling that is common with clinical trials is hope. Actually there are often two kinds of hope involved. The first is that the patient will be helped. The second is that by joining the trial, the person helps people who come after with the same health condition.  As with all treatments, there is always reason to hope.

NOTE: If emotions affect your daily life, let your doctor know. They may be related to a medication or treatment or to an underlying medical cause. In addition to medications, your doctor may recommend seeking professional help.

How To Get Your Insurer To Pay For The Costs Of A Clinical Trial

Most insurers pay for medical costs relating to clinical trials the subject of which is treatment, early-detection or diagnosis. Prevention trials are generally not covered.

Several states, including Maryland and Rhode Island, mandate that health insurance coverage extend to clinical trials for people with a life threatening condition.

To improve the chances of your insurer paying for the costs, take the following steps which are based on recommendations of the National Institutes of Health:

Step 1. Understand the costs associated with the trial.   

Ask the trial coordinator about any costs that must be covered by you or your health plan (those costs not directly covered by the trial itself).

Are these costs significantly higher than those associated with the standard care for your condition?

Step 2. Ask about the experience of other patients in the trial. 

Have their plans paid for their care?

Have there been any persistent problems with coverage?

How often have the trial’s administrators been successful in getting plans to cover patient care costs?

Step 3. Understand the provisions of your health plan.  

What provisions are there in your insurance about clinical trials? If you don’t have a copy of the plan, request one.

If there is a specific exclusion for “experimental treatment,” look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call your plan representative, and ask for specific information about clinical trials coverage.

Step 4. Try to enlist the help of a source of influence.

If you have your insurance through an employer or another group, speak with an employee benefits manager to find out how to best state your case and find out if the employer will support your claim for insurance payment.

This can be especially effective for larger companies, which provide insurance coverage for a large number of employees.

Step 5. Coordinate the request to the insurer with your doctor and the administrator of the clinical trial.

Insurance payment for trial related costs is often dependent upon the words or phrasing used by the doctor.

Depending on the requirements of your insurance policy, when you request pre-approval, or submit a claim, the wording should track as closely as possible the wording in the insurance policy.

If there have been problems with insurance companies paying the trial costs in the past, talk with your doctor and the trial coordinator about sending an information package to the insurer. The package should include studies supporting the procedure's safety, benefits, and medical appropriateness. This package might also include:

  • Publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits.
  • A letter that uses the language in the insurance contract to explain why the treatment, screening method, or preventive measure should be covered.
  • Letters from researchers that explain the clinical trial.
  • Support letters from your physician and patient advocacy groups.

Step 6. If the insurer's decision will be the deciding factor about whether you will join the trial, set a deadline to answer.  

Ask the trial coordinator to set a target date for the trial therapy. This will help to ensure that coverage decisions are made promptly.

Types Of Clinical Trials

The purpose of the trial varies according to the type of trial. However, all clinical trials are subject to the same tough controls aimed at protecting participants. In addition to trials that test the effectiveness of a new medication or treatment, clinical trials may also include the following:

Adjuvant Therapy

  • Adjuvant therapy can be defined as combining two treatments together in order to improve treatment outcome.  The purpose of adjuvant therapy trials are to determine if an additional treatment used with a proven treatment might improve effectiveness.
  • For example, the standard treatment for a particular kind of cancer may be surgery.  One group of patients may receive the standard surgical procedure and the other group may receive surgery in combination with chemotherapy. 
  • If the study proves that a combination of the two treatments is more effective than surgery alone, a combination of surgery plus chemotherapy might become the new standard treatment for that condition.
  • Adjuvant therapy studies are conducted using three phase trials.

Prevention Studies

  • Prevention studies are conducted on participants who may have an increased risk (such as from a family history) for developing certain conditions, such as heart disease or cancer.
  • These studies compare a group of people receiving no treatment, to a group that is prescribed a particular drug or change in lifestyle, such as diet.
  • Both groups may be monitored for many years to determine the effectiveness of a preventive treatment. These trials are not usually conducted in phases.

Early Detection Studies

  • Early detection studies assess the effectiveness of methods used for the screening and detection of a particular condition. An example would be the use of mammograms to detect breast cancer. Often conditions that are found early in their development are more easily treated or cured.  

How To Pay Your Share Of The Costs Of A Clinical Trial Without Insurance

Participation in clinical trials is not usually cost free. There are generally medical requirements that accompany the trial which are not paid for by the trial.

If you do not have insurance to pay these costs, and paying them yourself would create a hardship or even be impossible, be open with the trial coordinator and ask for help to find a solution so you can participate in the trial. 

If the coordinator doesn't have an answer for you, consider raising the following ideas:

  • Perhaps one of the trial doctors can see you in his or her practice for free, or at a low cost.
  • Perhaps the sponsors have a relationship with a local clinic.
  • Perhaps the sponsor (or the drug manufacturer if the manufacturer is not the sponsor) has or could create a fund to help pay costs.
  • Check disease specific non profit organizations. For instance, with cancer, both American Cancer Society and Cancer Care have programs that may be able to help.
  • If the trial will occur in a hospital, check with the hospital to see if it has a program that would help.
  • Check The Patient Advocate Foundation offsite link which offers an online resource with a financial services directory that lists resources to help with transportation, chidcare costs and other needs.
  • Most faclities that conduct clinical trials have a list of locol reources that help patients who join a clinical trial, including hotels that offer a discounted rate. 

Also see our article about Uninsured for ideas to help pay the costs outside of your relationship with the clinical trial.

It may seem to you as if you are asking the sponsors for a favor: you want to be in the trial, money is needed, you don't have it, and you're asking them to help solve your problem.

Instead, think about the situation from the sponsor's point of view: if you fit the eligibility requirements for the trial, you are a major asset they want. In fact, drug companies spend a lot of money looking for people like you. Without you, there is no trial. In addition, the more of you there are, the more credibility the trial has.