PATIENT'S RIGHT TO INFORMATION ABOUT A CLINICAL TRIAL
As a Cancer Patient, it is your Right to know and understand all the Necessary and Relevant Information about a Cancer Clinical Trial. All the Information about the Trial and the New Treatment that ‘You Require’ to arrive at an Informed Decision about your Voluntary Participation is Necessary Information. All the Information that ‘Must be made known to You as a Patient’ to be Completely Aware of all the Benefits, Risks, other details about the Trial and the Treatment, by the Researchers, is Relevant Information.
Important: Researchers must properly explain all the following Information to every Clinical Trial Patient in a ‘Language that the Patient understands’.
How Safe is the New Treatment? You must be made aware of all the Safety-related Information of the New Treatment that is available to the Researchers. This Safety-related Information includes all the results about the Safety of the New Treatment from All the previous Clinical Trials conducted using the same Treatment.
How Effective is the New Treatment? You must be made aware of all the Information related to the Effectiveness of the New Treatment that is available to the Researchers. This Information includes all the results about the Effectiveness of the New Treatment from All the previous Clinical Trials conducted using the same Treatment.
Will You be Exposed to any Additional Risk? You must be made aware of any Risks associated with the New Treatment, Trial Procedures, Investigations, other Treatments given as a part of the Clinical Trial, etc. You Must be made aware of the Precautions and Ways in which these Risks will be managed.
Will you be assured of receiving the Treatment if you participate in the Trial? You must be made Aware of All Details of All the Treatments that will be given in the Cancer Clinical Trial. The Treatment details include the exact Name and Nature of the Treatment or Treatments, the duration of the Treatment, any additional Treatments, known Benefits and Risks of the Treatments, etc. In some Clinical Trial designs called as Randomized, Blinded Trials, the patient may not be made aware of the exact Treatment that he is receiving throughout the duration of the Trial. You Must be made Aware of this possibility before the Trial. There are several types of the Trial Design like Ways of Randomization, Degrees of Blindedness, Placebo Arms, Control Arms, Treatment Arms, etc. which must be explained by the Researchers to the Patient and the Family before the Patient Enrolment. These details can determine whether or not you will receive the New Treatment being tested in the Trial. Sometimes you need to consult an Expert like your Oncologist to understand all the nuances of the Trial Design. This Information can be Critical for your Overall Cancer Treatment Plan and your decision whether or not to participate in the particular Cancer Clinical Trial.
How soon after agreeing for Enrolment will you receive the Treatment? Most Cancer Clinical Trials involve a Screening Process in which Patients interested in participating are evaluated in detail on the basis of the Eligibility Criteria of the Clinical Trial. You must be made aware of the possible outcomes and the duration of the Screening Process. The duration of the Screening and Enrolment Period will determine your Waiting Period before you will be given the New Treatment in the Trial. You and your Oncologist need to evaluate this Waiting Period with reference to your ongoing Cancer Treatment Plan. This Information can be Critical for your Overall Cancer Treatment Plan and your decision whether or not to participate in the particular Cancer Clinical Trial.
Who are the Sponsors for the Clinical Trial? You must be made aware of the Sources of Funding and the Sponsors who are conducting the Clinical Trial.
Will You be receiving any Compensation? You must be made aware of any Compensation or Financial Cover that will be provided to you, in case of any Trial-related Injury or Exposure to any Unnecessary Risk.
What is the commitment expected of you in a clinical trial? You must be made aware of the commitment in terms of frequency of visits and assessments while on the trial. This is particularly important if you plan to travel over a long distance to be enrolled into a clinical trial.
PATIENT'S RIGHT TO VOLUNTARY PARTICIPATION
The Cancer Patient’s Right to Voluntary Participation in a Clinical Trial is an essential and highly researched topic. The first step for a Cancer Patient is to know that it is entirely his or her decision whether or not to participate in any Clinical Trial. There should be absolutely no pressure from the Researchers, Sponsors or Trial Staff in any way. As a Cancer patient, you must ensure that you Know and Understand All the Necessary and Relevant Information about the Trial and the Treatment before signing the Informed Consent for your participation.
PATIENT'S RIGHT TO PRIVACY AND CONFIDENTIALITY
As a Cancer Patient in a Clinical Trial, your Right to Privacy during the Investigations and Treatments Must be maintained by the Researchers. The Researchers must maintain Confidentiality of your Trial-related Communications, Records, Personal Information and Investigations. The ICF must detail all the necessary Conditions related to Your Privacy and Confidentiality through the Trial duration.
PATIENT'S RIGHT TO CLINICAL TRIAL RESULTS
As a Cancer Patient participating in a particular Cancer Clinical Trial, you have the Right to Information about the Results of the Clinical Trial. You have the Right to know the Effectiveness and Safety Results of the New Cancer Treatment at the end of the Clinical Trial. Some Cancer Clinical Trials also ensure that each Clinical Trial participant and the Oncologist will receive a Copy of the Clinical Trial Report. You and your Oncologist need to evaluate the Trial Outcomes with reference to your ongoing Cancer Treatment Plan. This Information can be Critical for your Overall Cancer Treatment Prognosis
How Oncoshot Can Help You?
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