Clinical trials. BME215e Clinical Trials     Tutor-Marked Assignment July 2018 Presentation           BME215e Tutor-Marked Assignment SINGAPORE UNIVERSITY OF SOCIAL SCIENCES (SUSS) Page 2 of 3 This tutor-marked assignment is worth 12 % of the final mark for BME215e Clinical Trials. The cut-off date for this assignment is 28 August 2018, 2355hrs _________________________________________________________________________________ Submit your solution document in the form of a single MS Word file on or before the cut-off date shown above. Be careful of plagiarism and submission deadline. Marks will be deducted for plagiarism found and late submission. No limit to maximum number of words or pages. _________________________________________________________________________________ A new drug is developed by ABC Pharma Company for treatment of breast cancer / malignant tumour. The company is planning to conduct a clinical trial of the drug on breast cancer patients in Singapore for which they require your assistance in designing a PROTOCOL and Patient Information Sheet (PIS) together with an Informed Consent Form. Question 1 Develop a protocol of at least 3 pages in length. Examine the following contents or information in the protocol. a. Background of the study b. Objectives i. Primary question and response variables ii. Secondary question and response variables c. Design of the study i. Study population  Inclusion criteria  Exclusion criteria d. Subject selection and withdrawal e. Treatment of Subjects f. Assessment of efficacy g. Assessment of safety h. Data i. Statistical Considerations j. Ethical Considerations k. Financing and Insurance l. Reporting and Publication (50 marks)     BME215e Tutor-Marked Assignment SINGAPORE UNIVERSITY OF SOCIAL SCIENCES (SUSS) Page 3 of 3 Question 2 Design and illustrate a suitable Patient Information Sheet and an Informed Consent Form for the patients/subjects. Your submissions should be at least 2-3 pages in length. (50 marks) All your designs should be compliant with Singapore Hospital’s SOPs. Hint: You can download the templates of Protocol and Informed Consent Form from the Singapore Hospital’s IRB websites. —- END OF ASSIGNMENT —-


    PROTOCOL and Enduring

    Counsel Sheet (PIS) conjointly with an Informed Submit Frame

    1. Enhancement and pertinencynale

    The sanity wariness portraitures orderlyitys abquenched the sphere bear been confrontment a question in the frame of discourse the unintermittently increasing insist restraint medical portraitures. There is too a total of overstraining conducive medical media and a concatenate of other totals arising in the periphery. The predicament restraint the continuanceing population in Singapore and the increased rule of thoughtful illnesses such as life attacks and race hurry connected complications objecture to require hurry on Singapore’s medical orderlyity. Previous referableorious demographics elimination restraint Asia implied that Singapore is undivided of the Asia countries with the most rapidly continuanceing populations. The pertinencynale of the consider is that it is going to application unconditionally on the devotion and replacement arrangementes of withstand cancer endurings in Singapore and abquenched the cosmos-people. In restoration, the consider is going to furnish recommendations restraint prefer studies restraint persistent students as polite-mannered-mannered as advenient eliminationers in this topic.

    1. Objectives of the consider

    The objectives of this consider apprehend:

    1. Pristine Question

    What are the prerequisites restraint creating an objectified and pregnantly informative PROTOCOL and Enduring Counsel Sheet (PIS) conjointly with an Informed Submit Frame?

    1. Secondary questions

    How can undivided warrant and learn the contents of the IRB and the requirements of exhibition frames continuance disclosing institutions, textures and funding orderlyitys restraint Withstand Cancer endurings in Singapore?

    How can undivided succeed up with conclusions and recommendations that can be portraitured to instruct the legislation of Singapore and the secret medical portraiture furnishrs abquenched the emerging trends and textures connected to the superintendence of withstand cancer?

    1. Design of the Consider
    2. Consider population

    Eligible endurings restraint this consider earn be adults who are of 21 years of continuance and overhead. The sundericipating endurings must be admitted to the medical wards receiving medical portraitures such as objectocrinology. General medical aid and texture, neurology texture and be bereduced a persistent cancer texture program.

    Inclusion criteria

    The consider is snug on endurings who are admitted to the Singapore General Hospital and with a Lace Score of ≥ 10 to 1 restraint admissions that bear been made amid the last 3 months. Grounded on the eliminationer’s possess specimen largeness care frameula, the elimination earn demand to vaguely prefer a specimen largeness that earn apprehobject 840 endurings. The specimen largeness earn then be rearranged so as to convince the 1:1 pertinency government that has been firm restraint the consider.

    Exclusion Criteria

    The elimination population shfull refercogent apprehobject endurings bereduced the continuance of the eldership estimated at 21 years of continuance. This is owing of the issues embracing submit restraint incontrovertible textures.

    1. Topic and Nonpresentation

    In prescribe to oust bias connected to elimination studies, the preoption arrangement clarified restraint this consider earn be the vague respondent preoption. This is where respondents earn be clarified grounded on no feature shifting. Sundericipant nonpresentation is divulged restraint this elimination. Sundericipants earn be unobstructed to license the elimination arrangement at any stcontinuance of the consider at their possess choice. Texture of Topics

    It is the cunning of the elimination team that the topics be treated with at most reference and parity. The eliminationer commits to the retirement and confidentiality of sundericipants identical counsel as polite-mannered-mannered as the identical responses from individuals.

    1. Assessment of capability

    A pristine testing of the elimination arrangement earn be dundivided in the moderate ordains of the examine to designate the capability. This earn be dundivided to designate whether the examine earn be cogent to supplement the required counsel pertinent abundance restraint making conclusions and recommendations.

    1. Assessment of prophylactic

    An moderate examine earn be dundivided in relative to the texture of withstand cancer to designate the room of prophylactic restraint the arrangement that earn be inaugurated. In life, the most influential area of consequence apprehends assessing whether the arrangement and the questions requested bear a immanent restraint upsetting endurings and their replacement.

    1. Data

    Facts earn be firm and analyzed using twain the leading and indispenscogent modes. The indispenscogent modes that bear been clarified restraint this drill apprehobject questionnaires, interviews and identical refercogent attributcogent attributableice. The leading mode clarified restraint this examine earn mingle audio recording using an audio recording invention. The aim of the leading mode of facts collation and separation is to furnish meant to furnish supportive counsel restraint prefer separation. It is meant to stabilitate the findings of the indispenscogent separation. Full facts restraint this elimination must go through the sorting arrangement so as to fix that merely pertinent facts is applied. “Irpertinent facts” restraint the aims of this elimination earn refercogent be thrpossess quenched entirely. This facts earn be conserved restraint advenient references in elimination studies and express texture sentence making arrangementes.

    1. Statically Prophylactic

    The scheme earn portraiture twain indispenscogent and leading separation modes. Statistical considerations earn devolve modes that earn furnish pertinent counsel and media restraint this examine.

    1. Ethical Considerations

    These apprehobject best practices in the collation of counsel, separation and recitaling. The eliminationer is too obligated to refercogent profit any counsel abquenched the respondent or their responses to the notorious. In restoration, bereduced no mode should any emblem of restraint or defilement either financially or socially so as to rule their responses.

    1. Financing and Prophylactic

    The deep bail of the scheme earn take-up the duties of financing the senior arrangement of the scheme such as restraintfeiture of stationery and reimbursement of salaries discurrent other expenses. Prophylactic portraiture restraint the scheme earn be quenchedsourced to a secret prophylactic association that earn furnish a pregnant protect restraint full the pertinent media including civilized media and equipment.

    1. Reporting and notoriousation

    The elimination supervisor shfull be chargecogent on restraint the epoch of full meantime recitals including the ultimate recital. Meantime recitals shfull be generated whole object of the week with superintendence recitals nature generated on a monthly premise. These may too be generated by prescribe. The ultimate recital shfull be compiled at the object of the scheme.

    Question 2

    Cancer Submit

    Why is this consider nature manufactured?

    This consider is nature dundivided as a original edge restraint the texture of a withstand cancer enduring. The guide takeaway is nature cogent to collate sustaincogent customer counsel and to gain submit restraint texture.

    Who pays restraint the Consider?

    The scheme bail earn finance the consider continuance the eliminationer earn firmtle some of the fringe costs such as conveyance. Eliminationers are obligated to divulge any proprietar y and financial encumbrances of the consider so as to gain the acknowledgement of the respondents.

    Number of Sundericipants

    The population specimen restraint the consider earn be 840 respondents. This population earn be divided into brace where the original specimen earn be treated using a reduced doscontinuance and the contiguous using a exalted dosage. Predicaments of out-of-sorts edge proceeds earn be referableed and documented. Sundericipants must original submit to be set-down in either kind.

    What happens when undivided sundericipates

    Full sundericipants earn be evaluated from a hospital enhancement. Endurings earn be instructd consistently behind the texture has been administered. It earn be judicious to redeep bereduced the refercogent attributcogent attributableice of the doctors until it has been continuanceical that the texture is tolerable.

    Deep issues to referablee previous to origin the texture

    Moderate tests and procedures must be dundivided to asincontrovertible the equalize of the provision so as to be cogent or narrate to the objectives of the consider. It is too irresistible to referablee that medical portraitures earn objecture to be furnishd equal where the sundericipant ceases to be slower of the consider. The procedures and tests are calculated to ruminate those of a orderly cancer texture cycle.

    Consider Plan

    Start Here
    Withstand Cancer Surgery
    Medicines Portraitured in This ConsiderDoxorubicin + Cyclophosphamide attached by feeling uninterruptedly whole 21 days and general 4 times
    Randomize(You earn be in Group 1 or Group 2)

    Group 1Paclitaxel by feelingWhole 21 days restraint 4 scrutinizes
    Group 2No Paclitaxel                                

    Source: Author

    Duration of the Consider

    The sundericipant earn be bereduced medication and refercogent attributcogent attributableice restraint a continuance of 6 months. Behind endurings bear refined their medication, the doctor earn request the sundericipants to orderlyly scrutinize the hospital restraint prefer checks.


    Having decipher full the directives and requirements, I fit to sundericipate in the consider.


    Date            Sundericipant’s Signature restraint Submit

    Date            Person Gaining Submit


    Cosmos-people Sanity Organization. (2011). Standards and operational direction restraint ethics critique of sanity-connected elimination with civilized sundericipants. Geneva: Cosmos-people Sanity Organization.