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?
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?
3. How do I submit a proposal?
4. We would like to know if for submission purposes an investigator in Puerto Rico is considered US?
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.
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?
6. Who should I contact if I need information regarding the Investigator Studies Program?
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?
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.
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?
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
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.
1. Where do I go to obtain information on registering my MISP study?
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?
4. What does your company expect me to provide once the study is completed? How long do I have to publish/present the work?
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
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)."