{"id":430,"date":"2017-11-06T14:28:16","date_gmt":"2017-11-06T06:28:16","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=430"},"modified":"2021-09-20T20:13:42","modified_gmt":"2021-09-20T12:13:42","slug":"conducting-colorectal-cancer-clinical-trial-here-is-why-you-should-engage-investigators-in-canada","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2017\/11\/06\/conducting-colorectal-cancer-clinical-trial-here-is-why-you-should-engage-investigators-in-canada\/","title":{"rendered":"Conducting Colorectal Cancer Clinical Trial? Here Is Why You Should Engage Investigators In Canada"},"content":{"rendered":"\n

Colorectal cancer (CRC)<\/strong>, a<\/span>lso known as bowel cancer and colon cancer, is the development of cancer from the colon or rectum.<\/p>\n\n\n\n

Globally, colorectal cancer is the third most common type of cancer in both men and women making up about 10% of all cases. Currently, there is a significant focus on the development of drugs for the treatment of CRC.<\/p>\n\n\n\n

\"colorectal_cancer_clinical_trials_feasibility_credevo\"<\/figure>\n\n\n\n

Signs and symptoms<\/strong> of colorectal cancer include blood in the stool, a change in bowel movements, weight loss, and feeling tired all the time. It typically starts as a benign tumor, often in the form of a polyp, which over time becomes cancerous.<\/p>\n\n\n\n

Colorectal clinical trials around the world<\/h2>\n\n\n\n

A total of 5,412 studies on Colorectal Cancer have been recorded around the world, with most trials being in Europe(1,823), North America (2,284), East Asia (893), and Pacific regions (135). (Clinicaltrials.gov)<\/a><\/p>\n\n\n\n

\"colorectal_cancer_clinical_trials_worldwide_credevo\"<\/figure>\n\n\n\n

Currently, ongoing studies of colorectal cancer around the world are 1,610, particularly in North America (671), Europe (593), East Asia (364), and the Pacific region (43).<\/p>\n\n\n\n

OGD (USFDA) requires clinical trials on colorectal cancer drugs<\/h2>\n\n\n\n

Even for generic drug products, like<\/p>\n\n\n\n

  • Capecitabine<\/li>
  • Tipiracil Hcl, Trifluridine<\/li>
  • Regorafenib<\/li><\/ul>\n\n\n\n

    those used in the CRC treatment, OGD requires a clinical trial to be conducted.<\/p>\n\n\n\n

    Thus, applicants intending to submit for marketing approval of these drug products are required to conduct a clinical trial in CRC patients.<\/p>\n\n\n\n

    With generic drugs also requiring clinical trials in CRC patients (along with so many companies going for such clinical trials), there is a significant need to identify great sites and investigators, who can provide good quality data with faster recruitment.<\/p>\n\n\n\n

    Colorectal cancer phase 2-3 Clinical trial feasibility<\/h2>\n\n\n\n

    In a recently concluded clinical trial feasibility in Colorectal cancer patients on Credevo, the preliminary recruitment rate was assessed in Canada and Lithuania.<\/p>\n\n\n\n

    The study required<\/p>

    – Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum
    – Patient in third-line or fourth-line treatment for metastatic colorectal cancer<\/p><\/blockquote>\n\n\n\n

    Several investigators participated in this feasibility. Here are the salient results from the assessment.<\/p>\n\n\n\n

    1. Canadian investigators were more responsive than those in Lithuania.
    2.Average recruitment rate, reported by Canadian investigators, was 3.5 patients per site per month<\/strong>.
    3. Highest recruitment rate reported was 5 patients per site per month<\/strong>.<\/p><\/blockquote>\n\n\n\n

    Reasons to engage investigators\/sites for CRC clinical trials in Canada<\/h2>\n\n\n\n

    There are several.<\/p>\n\n\n\n

    1. Canada has sites with both private as well as public ownership, allowing you to take benefits of both sides.<\/li>
    2. Canadian investigators are definitely very qualified, experienced, and, most importantly, quite motivated to engage in clinical research.<\/li>
    3. The feasibility of any good clinical trial can be conducted quickly with active participation from site staff and investigators.<\/li>
    4. A recruitment rate of 3.5 – 5 patients per month is possible for CRC trials, making it one of the most favorable prospective rates.<\/li>
    5. Canadian regulatory process is quite smooth, well defined, and quite predictable. This makes it a lot easier to define projections for approvals and related timelines. Click here for details on the Canadian regulatory process<\/li>
    6. The regulatory approvals process is parallel for regulatory authority and ethics committee, saving some significant time.<\/li>
    7. A quite convenient regulatory approval time of 30 days.<\/li>
    8. Easy regulations for the import of study medications.<\/li>
    9. Easy study start-up and management.<\/li><\/ol>\n\n\n\n
      \n\n\n\n

      Contact investigators from this feasibility assessment or Get any other support for conducting such clinical trials<\/h2>\n\n\n\n

      Would you like to contact these investigators and assess feasibility with them for your clinical trial? or Do you need any other support for conducting such clinical trials?<\/p>\n\n\n\n

      Now, it’s very easy to do so.<\/p>\n\n\n\n

      Just provide your requirement details & email below. Don\u2019t worry, your email will not be published or shared.<\/p>\n\n\n