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Table 1 Stakeholder perspectives on open versus restricted access to trial protocols

From: Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

Stakeholder

Open access (online protocol)

Restricted access (NDA)*

 
 

Advantages

Disadvantages

Advantages

Disadvantages

Lead investigators

· Authorship acknowledged.

· Investigators do not have control over who has access to the protocol.

· Ownership established by the lead centre.

· Cost and time involved in establishing and defending NDAs.

· Plagiarism can be identified.

· Potential for plagiarism reduced.

· Investigators must adhere to protocol, or explain reasons why not.

· Protocol could be adapted or plagiarized by other investigators.

· Need to report all amendments to protocol.

· High degree of rigour associated with adhering to protocol and reporting.

· The lead investigator is the only one given credit for the protocol; other investigators do not receive adequate recognition of the effort that they have expended in developing the protocol.

· Co-investigators in other centres will need to sign NDAs before being able to establish the trial in their centre.

· Investigators might be less accountable for changes to protocol

Investigatorsinstitutions (universities, health care organisations)

· Affiliation acknowledged.

· Institution does not have control over who has access to the protocol.

· Ownership by institution established.

· Cost involved in establishing and defending NDAs.

Peer-reviewed funding bodies

· Public knowledge of funded study (that is, use of funding).

· Protocol could be adapted or plagiarized by other investigators.

· Confidence that protocol will not be plagiarized.

· Public cannot access study protocol.

· Less certainty that study will be conducted as funded.

· Greater accountability of investigators to adhere to funded protocol.

· Greater certainty that study will be conducted as funded.

Industry funding bodies

· Public knowledge of funded study (that is, use of funding).

· Widespread access to protocol.

· Confidence that protocol will not be plagiarized.

· Less certainty that study will be conducted as funded.

· Protocol could be adapted or plagiarized by other investigators.

· Others (competitors/public) will not have easy access to funded study protocol.

· Greater accountability of investigators to adhere to funded protocol.

· Greater certainty that study will be conducted as funded.

Site collaborators

· Availability of full protocol if they wish to seek that information.

· May believe that the protocol is open to change.

· Availability of full protocol if they wish to seek that information, but only if willing to sign a NDA that has been first agreed upon by their institution and the lead investigator’s institution.

· Cannot share details of the protocol with colleagues unless they are involved in the study.

· Can share the protocol with other potential collaborators within their institution.

· Cost (time/effort) involved in review and approval of NDA, even when the site subsequently decides not to participate.

· More open discussion.

Collaboratorsinstitutions (universities, health care organisations)

· Availability of full protocol if they wish to seek that information.

· May believe that the protocol is open to change.

· Availability of full protocol for review before joining the study if NDA is signed.

· Cost involved in legal review and approval of NDA.

· Co-investigators’ institutions need to sign NDAs before being able to establish the trial in their centre.

End-users of evidence (clinicians, policy makers)

· High degree of rigour associated with adhering to protocol and reporting.

· Potential for delay in publication because of greater rigour required.

· The study is unlikely to be duplicated.

· Possibility of selective and biased reporting.

· Possibility of adopting flawed evidence.

· Can check that findings are appropriately reported.

Patients (potential trial participants)

· Availability of full protocol if they wish to seek that information.

· Misinterpretation of open access information by those without sufficient background knowledge to understand it.

· Potential trial participants can be more confident the protocol is unique.

· Patients would need to ask specifically for a copy of the protocol if they wished to obtain details of the study.

· Can check that results are presented as intended.

· Possibility of selective and biased reporting.

· Possibility of flawed evidence being adopted.

Society generally

· Potential for replication of research, leading to availability of studies for inclusion in meta-analyses and more rigorous evidence to support practice.

· Potential for research being duplicated unnecessarily (waste of scarce resources).

· Trial is unlikely to be replicated.

· Possibility of flawed evidence being adopted.

· Protocols of publicly funded research will be openly available to the public.

  1. *Note that an NDA refers to protection of the protocol before a centre joins a trial, but this table assumes ongoing protection of the protocol during the conduct of the trial.