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MISP Frequently Asked Questions

Questions and responses are divided by each phase of the MISP. For additional questions, please contact the Scientific Leadership & Research Manager, for the therapeutic area aligned to your submission.

 

Submissions
1. Is there any flexibility regarding the identified "Areas of Interest"? If so, how is this determined and who might an investigator speak to about this?
The vast majority of funded proposals fall within Areas of Interest; however, some Committees may consider proposals outside the defined Areas of Interest if they are scientifically relevant. Before submitting a proposal that is outside the Areas of Interest, it is best to contact your Scientific Leadership & Research Manager to bring any requests to the attention of the MISP Chairperson.


2. Is there someone within your company I can speak with to see if there is interest in my study idea (before I write it up) or in case I have any questions in preparing the protocol?
Yes. Please contact your designated Scientific Leadership & Research Manager.


3. How do I submit a proposal?
Click on Getting Started to view the Requirements for Submitting a Concept or Full Protocol to download the proper documentation (concept templates, full protocol templates, etc.). Register/Sign In to register an account, or log into your registered account. Complete the submission by clicking on Add a New Application and upload the necessary documentation. Once submitted, a tracking number will be assigned to the proposal.


4. We would like to know if for submission purposes an investigator in Puerto Rico is considered US?
Puerto Rico is considered to be part of the US in MISP. All proposals from Puerto Rico should follow the processes listed in this website.


5. What is the difference between a concept and a full protocol?
A concept is a summary of your proposal that will be reviewed by the committee. It has specific sections (aims, hypothesis, methods overview, etc) that will provide the elements that are necessary for a pre-review of your proposal. Therefore, if the concept is rejected, you will not have spent a significant amount of time developing the proposal. If the concept is found to be of interest, the committee will request a full protocol for further review, which may or may not be accepted for approval. Requirements for Submitting a Concept for more information.


6. Who should I contact if I need information regarding the Investigator Studies Program?
Please contact the designated Scientific Leadership & Research Manager for your therapeutic area.


7. Do I need to submit a proposal if all I am requesting is study drug? How does this differ from a proposal where funds are also being requested?
MISP Committees review three types of proposals: funding only, product ( drug or vaccine) only, and both funding and product. A proposal requesting product only will be reviewed following the same standards as any other proposal.


8. Should I submit the entire proposal or just a summary to see if there is interest?
It is recommended to first submit a concept. A concept is a summary of your proposal that will be reviewed by the committee. If the concept is found to be of interest, the committee will request a full protocol for further review. Requirements for Submitting a Concept for more information.


Review & Decision
1. Who reviews the applications?
A research committee, chaired by the Global Director for Scientific Affairs, within the Office of the Chief Medical Officer, will review your proposal and budget. Support in the form of drug and/or funding is awarded based on scientific merit and consistency with the committee's scientific Areas of Interest.


2. How often do the MISP Committees meet?
MISP Committees generally meet monthly, but check with the designated Scientific Leadership & Research Manager.


3. What does our company expect from investigators submitting proposals?
The MISP organization funds proposals of scientific and public health interest that can be conducted professionally and on the agreed timeline. We expect to: 1) receive a well written proposal that is scientifically relevant; 2) that investigators demonstrate their ability to conduct a study within timelines; 3) if approved, that investigators agree in providing quarterly status updates and a final report of manuscript quality; 4) that results are disseminated.


4. What can investigators expect from your company?
1) Prompt and courteous response to a submitted proposal; 2) thorough scientific review of the proposal; 3) timely decision on acceptance or rejection; 4) information regarding rejection; 5) timely review of abstract/manuscript upon study completion.


5. What scientific points are considered when assessing a submitted protocol?
The following scientific points are considered: 1) that the study is aligned with the areas of interest or is of extraordinary interest otherwise; 2) that the study answers a specific scientific/medical question with a protocol that is designed to answer the scientific question/aim; 3) that a justification is made for the sample size (or a rationale for a reasonable estimated number); 4) that a data analysis plan is included with the protocol; 5) that a commitment exists to publish/disclose the findings for all studies.


6. If there are questions regarding the proposal will I have a chance to address them prior to a final decision being made?
Yes. If your proposal is not rejected and questions or clarifications arise, you have the option of resubmitting the revised version of the protocol.


Study Management
1. Where do I go to obtain information on registering my MISP study?
Investigator Instructions can be found on the US National Institutes of Health website


2. Does my trial need Human Subjects Review Board approval before I enter it into www.clinicaltrials.gov?
Provided the trial is not yet recruiting (you should never initiate the study before contract signature), you may register your trial in www.clinicaltrials.gov prior to getting approval from your human subjects review board (i.e., institutional review board or ethics committee). Before the first patient is recruited, board approval must be obtained and the protocol record updated accordingly.


3. Is there a FDA requirement for posting study results?
Yes. Clinical Trials for which results must be reported at www.clinicaltrials.gov (drugs or devices approved or cleared by FDA) are:
  • Trials of Drugs and Biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation
  • Trials of Devices: Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance required by FDA
  • Trials of Drugs and Biologics and Devices (as described above) in which all such products are approved or cleared by the FDA


4. What does your company expect me to provide once the study is completed? How long do I have to publish/present the work?
We expect to have a manuscript quality final report regardless of study results, and that data are posted at http://www.clinicaltrials.gov. Generally, the timeframe for obtaining this final deliverable should be within 12 months after study completion. Also reference the MISP Expectations, Activities and Timelines.


STUDY CLOSE-OUT
1. What is the timing for reporting basic results at ClinicalTrials.gov?
Generally, the responsible party for an applicable clinical trial for which reporting results is required, must submit basic results data not later than 1 year after the "primary completion date" (named "completion date" in the law), defined as "the date that the final subject was examined or received an intervention for the purposes of final collection of data for the *primary outcome*, whether the clinical trial was concluded according to the prespecified protocol or was terminated (emphasis added)."




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