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Previews begin October 2007. Premieres January 2008.

FDA Clinical Trials
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For more information on the clinical trial featured in this episode of CURIOUS, please refer to the Clinical Trials Web site for IT-101.

What is a clinical trial?

Clinical studies are integral to our understanding and treatment of diseases and medical conditions. There are two basic types of clinical studies: observational and interventional.

An observational study is designed to find out about the development or effects of a medical condition. Probably the most important observational study ever conducted was the Framingham Heart Study, which began in 1948 and is still ongoing. Researchers enlisted over 5,000 residents of Framingham, Massachusetts who had not suffered heart attacks or other cardiovascular problems. The objective was to discover how heart diseases started, developed, and eventually caused death. Participants have been given regular examinations and their data have been compared to find factors that were common among those who developed heart disease and rarely found among those who remained healthy. Characteristics (also known as risk factors) that were identified included high blood pressure, high cholesterol, excess weight, and a lack of physical activity.

An interventional study, or clinical trial, tests whether an intervention with a particular therapy will improve a particular condition. Findings from the Framingham Study have led to countless interventional studies to test the effects of diet and exercise programs on reducing weight, blood pressure, and cholesterol levels, as well as trials of new drugs to reduce blood pressure, cholesterol, and obesity. Follow-up studies have shown that these interventions not only improve risk factors but also can slow or stop disease progression and allow people to lead longer, healthier lives.

Clinical trials are conducted to investigate new drugs, medical devices such as pacemakers or artificial joints, innovative surgical procedures, and specific nonmedical procedures such as a psychotherapeutic technique for a certain condition. In addition, a clinical trial may directly compare two or more established drugs in treating the same illness or study a drug approved for one disease in the treatment of another.

How does a clinical trial work?

Every clinical trial is designed to measure specific effects of a treatment on a disease. For example, the primary endpoint, or main goal, when studying a cancer treatment might be to determine whether it helps patients live longer than currently available treatments. Secondary endpoints might be to establish whether it shrinks tumor size or prevents the spread of cancer to other organs.

Individuals must be told about the study in detail — including any potential risks or benefits involved — and sign a document of informed consent before being included in the study. Patients are not under contract. They may choose to leave a clinical trial at any time.

A clinical trial must have at least one treatment group and one control — or comparator — group. Patients are randomly assigned to one of the groups, and in most trials they aren’t told which they’re in. Only patients in the treatment group actually receive the treatment being studied. Those in the control group may receive either a placebo, which contains no real medicine, or a standard treatment already on the market.

Clinical trials follow strict ethical standards. Patients are not given placebo alone if withholding treatment would allow their condition to worsen or endanger their health.

Why participate in a clinical trial?

There are many reasons to take part in a clinical trial. Perhaps the most obvious benefit is access to new treatments that aren’t yet on the market. This may be especially important for those with life-threatening or chronic illnesses when conventional treatments are ineffective or cause troublesome side effects. Also, clinical trials are usually conducted in major health care facilities by physicians who are leaders in their fields, so patients may feel that they will receive better care in a clinical trial. Patients may also benefit emotionally by taking an active role in their treatment, or from knowing that they may help others by contributing to medical research.

What are the disadvantages of taking part in a clinical trial?

All medications have side effects, and an important part of a clinical trial is finding out what the long- and short-term side effects of a drug may be. Side effects may include headache, nausea, hair loss, rash, or other physical or psychiatric problems. Serious or life-threatening side effects sometimes occur.

Also, experimental treatments may not work as well as treatments already on the market. And not all patients in a clinical trial are given the treatment being studied. Some patients may receive a placebo (dummy pill) or another therapy against which the study drug is being compared.

Finally, clinical studies are often more time-consuming than simply being treated by one’s own doctor or local medical facility. Study participation may require longer travel to the medical center where the study is being done, more visits to the doctor, or more frequent or more complicated treatment.

Who can participate in a clinical trial?

In order to participate in a clinical trial, patients must first meet a wide range of eligibility criteria pertaining to age, gender, overall health, medical history, other medical conditions, and type and stage of the disease being questioned. Following these criteria helps both to ensure the accuracy of trial results and to protect the safety of trial participants.

For more information about clinical trials, visit www.clinicaltrials.gov, a Web site operated by the National Institutes of Health. This site includes complete information on clinical trials and how to participate in one, as well as an extensive database describing all current clinical trials and contact information for study coordinators.

  • comments (39)
  • B. Aprile

    Fascinating story about Ray Natha. How is he doing now?

  • S. Gordon

    Why aren’t the videos longer?

  • Mark Chopping

    I agree with S. Gordon: this story works 1000% better when the entire thing is shown. The edited web version is too chopped up.

  • Vijay Natha

    Ray’s doing great.

  • timothy jimson

    I loved this segment of the show & I’m very happy Ray is doing great. Also, these videos aren’t web versions of the show. They’re trailers … short previews the show. It looks like the shows air again in January.

  • Patrick Lafferty

    where might we obtain a copy of the entire story/dvd? We have a friend who might be able to benefit significantly!

  • Peter Paetzold

    How do we obtain more information on this trial?

  • M. Hepworth

    To get more information about clinical trials – click on the link in the text above (www.clinicaltrials.gov). For this specific trial, search on”IT101″ and the correct page will come up. You can also search on trials nationwide, including those in your area.

  • Alisa

    I work for City of Hope and am so happy that Ray is doing well! This is what we work for. Wonderul.

  • Theodore Ramage

    By the time the showed aired and I was aware that my wife qualified for the IT101 study, the enrollment had closed. When could phase II begin?

  • R P Krupczak

    Please advise when this segment is scheduled for broadcast in San Diego area. Thanks for the good work!

  • Robin Wlodarski-Burns

    I hope I can hold on till a trail comes to my area. But I have no cure for my cancer and the tumurs have spread to my left lung and have stopped all chemo as each different kind had me bed ridden etc and thats no quality. What a great show my sister taped for me as I dont get 13 but do get 21. When I thing how great Ray is doing I just cry. Thanks to that wonderful husband who got everyone in the company to find and sacrafice to make IT-101 Thank you and to his wife.

    • Margareth Wlodarski

      She held on as long as she could then went on to her next adventure

  • Andrea

    This has been a terrible year. My friends husband was diagnosed back in Sept with lung cancer. In December my father-in-law was diagnosed with lung cancer, and at the end of December my other friends father.

    Greg H, Ali K, Kamin k, and Sunita Y if you see this message please know that my thoughts and prayers are with you. I this clinical study might offer your hope!

  • C. Farnet

    Is it possible to view the entire episode online?
    I just watched this episode on my local PBS station and was very impressed. I would like to share it with others, and online is the most convenient format.
    Keep up the good work!

  • Lee Ramdin

    I’m Happy That Ray Natha is Doing Well and That IT-101 is Working For Him, I Just Found Out About Him and watch Him on Chan. 21 “Curious: Survival”; My Family Say’s He’s Related To Us, is There Anyway I Can Get In Touch with Him or Contact Him by E-mail or Home Address

  • Jhenna

    1-8-08 I just finish watching the show about Ray and his battle with cancer. What a success story. Thank God for the patience of the doctors and researches who put countless hours into this program. I know someone who was diagnosed with breast cancer in 2003, she had her breast removed. Early 2007 she was diagnosed with cancer in her throat and eye. What is her chances of being part of IT-101 program?

  • Adriane Hudson

    Received this from two of our daughters who watched the program last night. We don’t get the same shows, so we didn’t see it. Emailed this to me this AM and we watched it. Will ask Dr. Springett, Oncologist at Moffitt Cancer Center at U. of S. Florida, tomorrow when husband with acinar cancer of the pancreas tail that had spread to abdominal wall in specks and to a few lymph nodes, goes for conference tomorrow and discussion of his options for chemo/radiation, to see if he will get him into this Clinical Trial.

  • VRao

    My wife diagnosed pancreatic cancer stage 4 in 2007 summer and it is spread to lymph nodes and peritonium and ca 19-9 is 425 when it was diagnosed. She is taking chemo for last 5 months and now ca 19-9 is 75. But tumer size at pacreatic body and tail didn’t reduce much. Is she eligible for this IT-101 trial. I also need Mr Ray contact details if possible.

  • wallace e brown

    attention: MR MARK DAVIS. GOD HAS TRULY TOUCHED YOU. he has given you the knowledge to help your fellow man. i just wish that the rest of the world would catch up ! instead of destruction. we are so smart that we are stupid. my uncle jim has a head tumor.we are out of options.good health is not an option. i am willing to pay & sign any document to get him in a study. are buy IT-101 from some place.no limit…thank you.

  • G. Larsen

    Let’s everybody plant one of (It101comes from tree bark)those trees, I bet they’d grow great here in Washington State. I hope the “cure for everything tree” doesn’t get cut down in the Amazon forest tomorrow.

  • Alan Spy

    The Anti-Cancer Drug IT-101 Episode was very moving. Amazing show…beautifully produced and edited.

  • craig clark

    very good material!

  • Louis Biedka

    Can I obtain a copy of the show? Thank you

  • marilyn arland

    my twin sister is in stage 4 of bone cancer.The mass is totally wrapped around her femur , spreading into her pelvis. She also has multiple tumors in both lungs. She is on chemo right now… She is 56 yrs old and has suffered tremendously. Is there any help for her with this 1T-101 program?

  • Doodee

    Thanks for sharing

  • Dolly Bates

    Such a hopeful program. I pray every day for something to help my 10 year old grandson who has brain cancer. September 2007 the doctors gave him 3 weeks to live. He is still here. No more treatments are scheduled.

  • Jesspahagolla

    I’d prefer reading in my native language, because my knowledge of your languange is no so well. But it was interesting! Look for some my links:

  • Roger Evenson

    Regarding IT-101,my brother and I have been searching for the whole program, without any luck. We are willing to pay for a disk or whatever. Is there a WWW site to view the whole episode?
    Thanks

  • Audrey Fisher

    Would like more info on IT-101 I have cancer of the throat which was just diagnosed.

  • Jesspahagolla

    I’d prefer reading in my native language, because my knowledge of your languange is no so well.

  • jodine

    Saw the program on my PBS station.It was interesting, but don’t understand why people don’t
    don’t improve their immune systems, so that their body can get rid of the cancer itself.see
    smartchoice4health.

  • cancerpatent caregiver

    Why? Because boosting the immune system may help prevent cancer but once you have it, the cancer keeps on growing.
    The rest of the body is supported from the immune-boosting but the cancer is rarely cured by it. Some even think the tumor, reaching for oxygen and nutrients (hence spreading/metastasizing), might actually be supported by the nutrients! Hopefully that theory is wrong.

  • kathy hays

    My brother has lung cancer, which is in the lining of his lungs. It is inopperable. Anyone else have this cancer? What treatments are you undergoing?

  • richard luft

    This was a fascinating program. I’m wondering if there has been any update to Mr. Natha’s condition.
    Hopefully, Vijay will get this post and give us an update. Or perhaps PBS might have the ingenuity to follow-up on stories like this, to keep the public informed.

  • AJ

    Thank you Prof. Davis.

  • Vijay

    My dad passed away 24/10/08. His clinical trial was over and then he deteriated pretty fast after they stopped the drug. I’m certain he would have lived longer had they increased the dosage.

  • Cary Saccente

    Dear Vijay,
    My sincere sympathy for you father’s passing away Oct. 24, 2008, several years ago. Tonight I watched the very touching film depicting your father.

  • http://www.netipotsolutions.org neti pot salts

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CURIOUS is made possible through the generous support of TIAA-CREF.

Additional funding for CURIOUS is provided by:
Peter and Merle Mullin
Stan and Barbara Rawn
TIAA-CREF Produced by Thirteen/WNET New York