• 【製薬企業・研究機関向け】 新型コロナウイルス(COVID-19)に関する治験および臨床研究 を対象とした治験情報公開インフラシステムpuzz(パズ)の無償提供について

    当社は新型コロナウイルス(COVID-19)の感染症対策の一環として、当社が提供する製薬企業・研究者と患者さんを直接つなぐSaaS「puzz(パズ)」と治験情報公開プラットフォーム「smt(エス・エム・ティー)」を新型コロナウイルス(COVID-19)の治験および臨床研究について無償提供を開始致しました。puzz(パズ)では治験・臨床研究の一般患者向け試験情報公開機能をベースにスクリーニング機能、試験実施医療機関の選択、参加応募、被験者管理までがオンラインでワンストップ管理できます。必要に応じて被験者募集広告機能も備えております。現在も新型コロナウイルス(COVID-19)感染症の感染拡大が続くなか、各製薬企業、研究機関などでは治療薬やワクチン、診断薬などの開発が急速に進められようとしております。罹患された患者さんの治験実施医療機関への集積および、回復者からの抗体採取の支援において、当社の提供する治験情報インフラの活用により、治療薬やワクチンの開発のさらなる推進に寄与したいと考えております。

    サービスの展開図

    サービス展開図
    puzz

    代表取締役CEO 猪川 崇輝からのメッセージ

    新型コロナウイルス(COVID-19)の感染拡大が広がる中、直近では100名以上/日の感染者が確認されるようになりました。この環境下で、製薬企業と共に治験情報の一般公開サービスを進めている当社として、治療薬やワクチンなどの開発の迅速化に何かお役に立てないかとスタッフ全員で考え、今回のシステム無償提供を開始することを決断いたしました。具体的には製薬企業・研究機関が実施試験情報の共有機会が必要な場合や罹患者、完治者の一般公募が必要な環境で当社システムを活用いただけます。当社は『我々のプロダクトを通じて治験プロセスの効率化を図り、患者さんに1日でも早く、新たな治療法の選択肢を届ける世界を作っていく』というビジョンを掲げております。このビジョンを全うすべく、微力ながら患者様、開発を行う製薬企業や研究機関のお役に立てれば幸いです。

    無償提供について

    • 治験情報インフラ「puzz」の無償提供期間:
      2020年4月~2021年3月(1年間)
    • 無償提供条件:
      製薬企業・研究機関・アカデミア等において、新型コロナウイルス(COVID-19)の治療薬及びワクチン等の開発を目的とした治験を含む臨床試験・臨床研究を行う場合。
    • 提供方法:下記『お問い合わせ』にて問い合わせ下さい。

    お問い合わせ

    お問合せは下記のフォームにてお申し出ください。お問合せの対応は10:00~19:00(月~金)の間とさせていただきます。 内容によっては、時間がかかる場合がありますので予めご了承ください。

  • 100 patients with Sjogren’s syndrome give their advice about how to better handle their disease

    Sjogren’s syndrome is a disease with a diverse range of symptoms such as dry mouth, dry eye, lethargy, and joint pain which greatly impact quality of life. However, patients’ experience of their disease symptoms and how they manage their diseases is not well known. QLife conducted a survey in a Japanese Hospital with 100 patients at a Rheumatology Clinic to discover their “real opinion” about their disease. In addition, Clinic Director, Professor Akira Sagawa gave his insight about the questionnaire results.

    Sagawa Akira Rheumatic Clinic Director
    1969:Graduated from Hokkaido University School of Medicine
    1993:Manager of Yamanoue Hospital Center for Rheumatism and Collagen Disease
    1995:Director of Hospital
    2006:Opened Sagawa Akira Rheumatic Clinic in Sapporo City Chuo Ward
    http://www.sagawa-akira-clinic.com

    1. 1. Patients report dry eye (99%) and dry mouth (98%). Over 80% report the disease “influences daily life”
    2. 2. After symptoms first appear, diagnosis as Sjogren’s syndrome takes on average three years , but the longest was 44 years
    3. 3. Diagnosis of Sjogren’s syndrome, 40% of patients to confront with the disease
    4. 4. Advice from patients: Do not strain yourself, avoid stress
    5. 5. To alleviate the pain of Sjogren’s syndrome
    6. 6. Contact us
    Patients report dry eye (99%) and dry mouth (98%). Over 80% report the disease “influences daily life”

    When patients were asked about their current symptoms and their impact on daily life, almost all complained of “dry eye” (99%) and “dry mouth” (98%) symptoms, as well as “feeling fatigued” (84%), and “joint pain” (82%). Regarding the degree of influence of each symptom, 84.7% of patients experiencing dry mouth and 83.8% of patients experiencing dry eye answered that their symptoms were “very influential on their quality of life” or “slightly affected their quality of life”.Furthermore, dry eye (33%) and dry mouth (29%) were the symptoms that many patients want treated.

    Dr. Sagawa’s Commentary

    Sjogren’s syndrome is characterized by a range of unpleasant symptoms, especially dry eye and dry mouth which many patients report affect their daily life. There are eye drops that improve dry eye and drinks that encourage the secretion of saliva, so patients are encouraged to consult their doctor to find the best solution for their complaints.

    In the survey, patients were asked to describe their episodes of dry mouth and dry eye symptoms. Here is what they had to say:

    Dry Mouth

    • I cannot eat rice crackers and cookies without water.
    • My tongue was rough and tingling, so it was difficult to eat.
    • Because it tends to cause tooth decay and periodontal disease, I have increased how much I brush my teeth.
    • When my thirst is terrible, the inside of my cheek sticks to my teeth.
    • Dry mouth causes trouble talking which influences socializing.
    • Keeping myself hydrated brings me to the toilet a lot.
    • When asleep, my tongue stuck to my upper mouth and I could not breathe.

    Dry eye

    • My eyes always hurt and the sun is always bright, so I do not like to go out on sunny days.
    • I was using contact lenses, but since my eyes are bad, contact lenses stick to my eyes and are hard to remove, so I stopped using them.
    • My eyes always hurt and I constantly have bloodshot eyes. So now I often narrow my eyes.
    • I need to carry eye drops because eyes are always dry. When I do not carry them, I need to yawn to release tears.
    After symptoms first appear, diagnosis as Sjogren’s syndrome takes on average three years , but the longest was 44 years

    The survey showed that from the onset of symptoms, it takes three years on average (44 years as the longest) to be diagnosed with Sjogren’s syndrome. On average respondents reported 1.8 years from the symptoms’ first appearance until they sought their first medical consultation. The average period from the first medical consultation to the diagnosis of Sjogren’s syndrome was 1.2 years.

    Dr. Sagawa’s Commentary

    Even if people are aware of the drying of their eyes and mouth, some people endure their symptoms due to their old age and do not see their doctor. Dryness of the eyes and mouth are pathological symptoms with various possible causes, so it is necessary to investigate what is causing a patient to experience them. If these symptoms occur, see your doctor as soon as possible. If you think it may be Sjogren’s syndrome, it is better to consult with a collagen disease and rheumatology specialist.

    Diagnosis of Sjogren’s syndrome, 40% of patients to confront with the disease

    When asked if there was a change in their feelings about facing their disease after being diagnosed with Sjogren’s syndrome, 9% answered “I was much more positive” and 31% “I became somewhat positive”. Below are comments from the patients who became positive after their diagnosis.

    • Once the cause was identified and the medicine worked, I did not need to lie down for long time even when I work or go out.
    • I have been called a liar and treated as lazy, depressed, and a malingerer for many years, but I was relieved that I was right.
    • Because the symptoms are relatively light and it is possible to deal with them on my own, I thought that I could work or endure it.
    • I was anxious because the cause was uncertain, but from the day I knew the cause, I could face it.
    Advice from patients: Do not strain yourself, avoid stress
    • It is necessary for families to understand your disease, so tell them about it and ask for their help when something happens.
    • It is important to meet a doctor who you can consult about anything regardless of the size of the hospital because you will need long-term treatment.
    • The pain and difficult time you are having is hard to share to get understanding from other people. Relax and avoid stress by making yourself free.
    • First of all, it is most important that your family understand that it is a disease. You will feel comfortable when your family communicate with you normally after gaining their understanding. If you can become a selfish character then you will be more comfortable.
    • Become slightly sensitive to your body and when you feel tired, do not suffer from it, please take care of yourself. It is important not to strain yourself and to rely as much as you can on your family and friends.
    • Think about steps with a bright mind without worrying or sadness. It is nobody’s fault, so do not think “Why me …” That way you will not become depressed. Always convey your gratitude to your family and medical personnel. It is the secrets to good relationships.
    To alleviate the pain of Sjogren’s syndrome

    “Sjogren’s syndrome is often accompanied by painful symptoms such as dry eyes, dry mouth, feelings of fatigue, and joint pain, but by visiting medical institutions it is possible to relieve your symptoms and improve your quality of life. Also, in order to live well with this disease, it is important to talk to your family and the people surrounding you (not only to a doctor). Please do not try to solve this problem alone, please talk with your doctor, family, and other patients.”(Dr. Sagawa)

    Contact us

    Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).

    Reference:
    2017/04/26 published.
    Article titled “100 patients with Sjogren’s syndrome give their advice about how to better handle their disease”
    Retrieved from https://www.qlife.jp/square/feature/sjogrens_syndrome/story62099.html

  • Matching Platform for Patients and Investigative Sites

    In order to solve the challenges of recruiting patients in clinical trials, Buzzreach offers services to people who are suffering from health problems by providing clinical trial information to the public and improving clinical trials’ searchability on the internet.

    We have created online matching platforms called Search My Trial(smt) and Post Your Buzz (puzz), which allow patients to interact with investigative sites and SMOs and makes clinical trials more familiar and accessible to the general public.

    1. 1. Accelerate Patient Recruitment at Investigative Sites
    2. 2. Smt, the Expedia for Clinical Trials
    3. 3. Collective Management of Clinical Trial Information with Puzz
    4. 4. An Overview of How the System We Provide Works
    5. 5. Contact us

    Accelerate Patient Recruitment at Investigative Sites

    Clinical trials are a necessary step for delivering new and more advanced medicines to patients. However, at present, there is no resource available for patients to guide them towards clinical trials that they may benefit from. In order to change this, we created an online matching platform to connect potential patients with investigative sites and help them understand that participating in a clinical trial is a potential option.

    In Japan, there are approximately 600 clinical trials a year covering a total of 50,000 participating patients. These clinical trials are conducted at over 20,000 sites however, 70% of the trials fail to meet the deadline due to lack of participants. One of the main reason is the lack of trial information available to the public. If investigative sites emphasize more on the promotion of trials, the information will be more open to the public, raising the participation rate. This, in turn, would lead to cost reduction for pharmaceutical companies due to the decrease of drug development time as well as newer drugs reaching patients quicker and cheaper.

    Furthermore, as the movement grows, the value and awareness of existing patient specialized recruitment companies (PRO) will rise. We believe that our platform will help raise awareness about companies and organizations involved in clinical trials and eliminate past stigmas surrounding clinical trials.

    Our platform provides the following 4 services:

    • Patients are able to search for relevant clinical trial information about trials they are potentially eligible to participate in.
    • Investigative sites are able to promote their specific clinical trials’ information.
    • Sponsors and CROs are able to collectively manage the status of each of their clinical trials.
    • Potential clinical trial patients and investigative sites will be able to be matched with one and other.

    Smt, the Expedia for Clinical Trials

    These days, people book flights and hotels using booking engines like Expedia. These provide the best, most relevant flight and hotel information to suit the person’s specific travel needs: such as location, schedule and budget. Using a similar model, smt works as a matching platform to link patients who are interested in participating in clinical trials with the most relevant sites conducting clinical trials based on a patient’s needs such as diagnosis, symptoms and geographical location.

    Information is automatically collected from JAPIC, JMACCT, Clinical Trial Registration System, ClinicalTrials.gov, and UMIN, as well as posts from investigative sites so that we can offer clinical trial information to patients and people suffering from health problems. By providing as much information as possible, we aim to support potential patients to better understand clinical trials and encourage them to participate in clinical trials.

    Figure 1: Smt and the Services it Provides

    Collective Management of Clinical Trial Information with Puzz

    PUZZ is a convenient platform to manage registration of clinical trial information and recruitment progress after registration. It also has a function of panelising potential patients in the hospital.
    What PUZZ can do:
    • Vendor management
    • Campaign management
    • Referral management
    • Visit management
    • System training
    • Double entry check
    • Communicate with and send alert to patients
    • Authority management
    • Waiting list of clinical trials
    • Registration of clinical trials to partner networks in real time

    Figure 2: Puzz and the Services it Provides

    An Overview of How the System We Provide Works

    Clinical trial information will be posted by pharmaceutical companies onto puzz where it will link with smt as well as provide a database for further provision of the information to the public in various ways. Smt has a diverse partner network with companies and organizations with patient communities and healthcare communities. Our partner network can be divided into three types: health care media, companies holding clinical trial specialized volunteer databases, and patient advocacy groups. By increasing awareness of clinical trials through our partner network it is possible to efficiently educate patients, their families, and people suffering from health problems about the opportunities that clinical trials present. Other than that, clinical trial information will also be published via posters and leaflets in medical facilities, brochure distribution to patients in hospitals and leaving contact information on medical institution homepage as well as pharmaceutical companies’ pipelines. When potential participants apply, they will be screened online according to selection exclusion criteria and qualified individuals will then be referred to investigative sites.

    Figure 3: Overview on How Smt and Puzz Works

    Contact us

    Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).

  • Today’s clinical trial subject recruitment in Japan

    Clinical trials are fundamental for ensuring the safety and effectiveness of new medicines in real people. The entire clinical trial process involves recruiting volunteers through a careful selection process, obtaining informed consent from volunteers, testing the investigational new drugs in a controlled and carefully monitored environment, gathering and interpreting the data, and finally receiving approval to release a new drug from the Ministry of Health, Labor and Welfare.

    Recruiting patients to participate in clinical trials is one of the key links in the chain of delivering new medicines to the public, and hospitals. In Japan, as with other places around the world, there are certain barriers to timely patient recruitment which can make a clinical trial run behind schedule, costing time and money. Buzzreach provides unique solutions to overcome the challenges of patient recruitment by matching the right clinical trials with the right patients. Using the internet, our services bring clinical trial information to the public and improve the search ability of clinical trials by targeting communities of patients.

    1. 1.Issues and current status of the clinical trial market from patients’ perspective
    2. 2.Patient-related clinical trial market
    3. 3.Current status of the clinical trial patient recruitment market
    4. 4.Clinical trial sites’ patient recruitment
    5. 5.Bringing clinical trials closer
    6. 6.Contact us
    Issues and current status of the clinical trial market from patients’ perspective

    Right now, we can see many issues in the clinical trial market. The general public’s understanding of clinical trials is still fairly rudimentary, and there is a negative image surrounding medical research.

    Although there are huge numbers of clinical trials taking place in medical institutions across Japan, the information which is shared with the public is still very limited. Right now, there is no easy-access, standard place for patients, their families, and people concerned about health to search for information about clinical trials.

    Right now, more than 60% of Japanese clinical trials do not hit their target deadlines. Running overtime, increases the cost for pharmaceutical companies and delays new drug approval. Buzzreach addresses these problems by providing streamlined, easy-to-access information about participating in clinical trials to the public.

    Patient-related clinical trial market

    Many clinical trial sites and patients are involved in clinical trials in Japan. Here are the annual statistics for Japan:

    • Regardless of whether an SMO is involved or not, about 20,000 to 30,000 sites conduct clinical trials.
    • Pharmaceutical companies contract around 100,000 enrollments.
    • Clinical trial participants sign 240,000 informed consent forms.
    • o Approximately 70,000 patients actually participate in clinical trials.

    While clearly many clinical trial sites and patients are involved in clinical trials, we at Buzzreach believe there is room for improvement! We aim to foster smoother information disclosure, information sharing and information retrieval.

    Current market status of the clinical trial patient recruitment

    There are eight main patient recruitment organizations (PRO) involved in clinical trial patient recruitment in Japan, and their net worth is worth about 40 million USD and together they recruit around 6,000 patients a year.
    PROs operate on a project-by-project basis by recruiting patients for participation in specific clinical trials using their own volunteer databases. PROs only support projects which they are participating in, so the information on their websites is limited to specific diseases related to each project.
    On the other hand, the Buzzreach platform is designed to share information about the majority of studies taking place in Japan – even those not posted on PRO websites. We strive to get as much user-friendly clinical trial information to the public as possible.

    Clinical trial sites’ patient recruitment

    Although clinical trials are absolutely necessary for making sure a drug is safe and effective before it hits the market, they still have a negative image in Japan. Buzzreach aims to raise the profile of clinical trials by increasing awareness of the opportunities that they can offer patients. We provide a hub of up-to-date, relevant, and easy to understand information and education to make clinical trials more accessible to the public.
    The Buzzreach platform offers information on many different diseases, and creates and fosters communities of people who are interested in accessing clinical trial information. The matching platforms called SearchMyTrial (SMT) and Puzz allow patients and sites to connect with each other.

    Buzzreach’s platform meets a lot of different stakeholder needs:

    • Patient and their families can search for accurate and up-to-date disease and symptom information, as well as relevant clinical trial information.
    • Clinical trial sites (or SMOs) can post information about clinical trials conducted at their sites and reach specific patient communities.
    • Patient and sites can be matched with each other on the clinical trial matching platform.
    • Sponsors can access patient recruitment strategies on single platform.

    If all 20,000 – 30,000 Japanese clinical trial medical institutions use the Buzzreach platform, we are sure to see a great improvement in the quality, speed, and cost effectiveness of clinical trials in Japan, as well as huge improvements in Japan’s public image of clinical trials.

    Bringing clinical trials closer

    These days, people book flights and hotels using booking engines like Expedia. These provide the best, most relevant flight and hotel information to suits the person’s specific travel needs, such as location, schedule and budget.

    Using a similar model, Buzzreach provides relevant clinical trial information based on a patient’s needs such as diagnosis, symptoms and geographical location. Information is automatically collected from JAPIC, JMACCT, Clinical Trial Registration System, ClinicalTrials.gov, and UMIN as well as posts from clinical trial sites. Just like the popular travel search engines, Buzzreach works as a matching platform to link patients who are interested in participating in clinical trials with the most relevant sites conducting clinical trials in their region.

    Contact us

    Please inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).

  • 日本の新薬開発における現状と課題

    治験(臨床試験)は、新薬を医療の現場へ送り出すために、必要な重要なステップです。
    そのためには、人で安全性と有効性を確かめる必要があり、ボランティアを募集し、同意を得て治験薬(薬の候補)を試してもらい、データを収集、最終的に厚生労働省の承認を獲得するという手順が必要となります。

    その中で、私たちBuzzreachは、治験における被験者確保の課題を解決するため、主に患者筆頭に一般の方への臨床試験情報オープン化/インターネットを用いた検索性の向上化をメインとしてサービスを提供しています。

    1. 1.我々がサービス展開する、『患者目線』の臨床試験マーケットの課題と現状
    2. 2.臨床試験で患者に関わるマーケットは、多くの医療機関/患者と接触
    3. 3.臨床試験被験者募集に関わるマーケットの現状
    4. 4.医療機関でも治験被験者募集ができる時代
    5. 5.もっと治験(臨床試験)を身近に
    6. 6.お問い合わせ

    我々がサービス展開する、『患者目線』の臨床試験マーケットの課題と現状

    臨床試験のマーケットには、課題が多くあります。

    • 治験を含む臨床試験のイメージは、まだまだ一般の方にはグレーである。
    • 日本では多くの医療機関で臨床試験が行われているのに、情報公開量が極めて少ない。
    • 患者やその家族、健康を気にする人が臨床試験をどう探せばいいか、どう参加するか、インターネットを含めてスタンダードな手段がない。
    • 上記の課題も原因となり、日本の臨床試験は決められた期間に終えられないものが60%以上ある。
    • 決められた期間に臨床試験が終えなければ、メーカーの開発コストは上がり、新薬承認も遅くなる。

    私たちはこれらの5つの課題を、臨床試験情報のオープン化をテーマにしたサービスで解決することを目的としています。

    臨床試験で患者に関わるマーケットは、多くの医療機関/患者と接触

    日本の臨床試験には多くの治験実施医療機関と患者が関わっています。

    • SMOが関与するしないに関わらず、1年間で日本で動く延べ治験実施医療機関数は、約20,000〜30,000
    • 製薬企業が上記治験実施医療機関と契約し、達成する1年間の治験契約症例数は、約100,000症例
    • 上記の治験実施医療機関で、治験に参加するために患者に同意を取る数は、約240,000名
    • 上記の治験実施医療機関で、実際に治験に参加をしている患者の数は約70,000症例

    これだけ多くの治験実施医療機関や患者が関わりあう中、スムーズに情報公開・情報共有・情報検索が行える環境日本の臨床試験マーケットには整っていません。

    さらに被験者募集のマーケットを見てみましょう。

    臨床試験被験者募集に関わるマーケットの現状

    日本の臨床試験被験者募集の市場はおよそ40億円です。
    これは、被験者募集専門機関(PRO)8社の総売り上げ規模です。

    これら8社が年間で募集する疾患フェーズの募集総数(投薬)は、およそ6,000例です。

    PRO(Patient Recruitment Organization:臨床試験被験者募集機関)は製薬業界からも認知されてきている反面、プロジェクト単位でスポンサーから受注した臨床試験のみ、各社で保有するボランティアデータベースに対して被験者募集活動を行います。
    そのため、多くの患者に対する臨床試験のイメージ払拭含め、全ての領域の患者に対して臨床試験情報を届けられていないことの方が多く、日本全体の臨床試験促進化には残念ながら至っていないのが現状です。

    私たちBuzzreachは、ここをターゲットとし、ソリューションを提供します。

    医療機関でも治験被験者募集ができる時代

    臨床試験(治験)はよりよい医薬品を患者に届けるために、必要なステップです。
    しかし、イメージがまだまだ悪いのも事実です。
    これを変えるために、全ての悩んでいる患者や家族と治験実施医療機関とを繋ぐ環境(プラットフォーム)を用意し、治験という新たな治療の選択肢があるということを啓発していく必要があります。
    治験に携わる全ての医療機関(20,000〜30,000)が少しづつ啓発を行えば、治験に対するイメージも良くなり、結果的に日本の臨床開発の質の向上、スピードアップ、コストダウンに繋がっていきます。

    そこで、私たちが提供することは4つです。

    • Patient:患者やその家族は我々が提供する臨床試験マッチングプラットームで悩んでいる病気や症状を『検索』。
    • Site:臨床試験実施医療機関(またはSMO)は医療機関専用のプラットフォームに自院で実施している治験情報を『POST』。
    • Answer:我々のプラットフォーム上で患者と医療機関を『マッチング』。
    • Sponsor:スポンサーにはさまざまな被験者募集戦略をひとつのプラットフォームで提供。

    もっと治験(臨床試験)を身近に

    私たちは治験をもっと身近なものにしていきたいという思いから、患者と医療機関が相互にやり取りできるSearchMyTrial(SMT)とPuzzというマッチングプラットフォームを用意しました。

    多くの旅行を考えている人は、フライトやホテルを探す際、最適なフライト情報や知らない国のホテル情報を提供してくれるエクスペディアを利用します。
    同様に我々は、治療法や症状で悩んでる人が、私たちのプラットフォーム上で最適な治療の可能性を探せるよう、臨床試験情報を提供します。

    臨床試験の情報は、日本で実施されている全ての臨床試験を患者へ提供出来るよう、主に一般公開されているJAPIC、JMACCT、臨床試験登録システム、ClinicalTrials.gov、UMINより自動的に収集、さらに各治験実施医療機関からポストされた情報も提供することができます。患者やその家族が検索しやすく、なるべく多くの臨床試験情報を提供し、少しでも臨床試験のことを分かり易くするためにフォローをします。

    私たちが提供するサービスは、患者が悩んでいる病気を知ることができ、その上で治験という選択肢があることを知っていただける、患者と医療機関をマッチングする日本で初めてのプラットフォームです。

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