Randomized Clinical Trial (RCT) to test the effectiveness of a new innovation support model

Last registered on October 04, 2021

Pre-Trial

Trial Information

General Information

Title
Randomized Clinical Trial (RCT) to test the effectiveness of a new innovation support model
RCT ID
AEARCTR-0008309
Initial registration date
September 29, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 04, 2021, 2:37 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
IDETRA

Other Primary Investigator(s)

PI Affiliation
INFO
PI Affiliation
INFO

Additional Trial Information

Status
On going
Start date
2019-12-01
End date
2022-12-31
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
The Trial aims at developing a RCT to compare the socio-economic impact produced in the SMEs that choose to innovate based on a previously identified challenges with economic support against those that innovate based on a previously identified challenges with economic support and guided by the tutelage of (co-creation) and supported by INFO with “go to market” services. The main goal is to analyse the performance and the advantages and constraints for INFO of one or the other model.
Additionally, other interesting issues can be addressed in the RCT:
•Commitment to business digitisation to get out of the Covid19 crisis
•To satisfy technological needs of large-tractor companies located in the Region of Murcia through the competition of SMEs acting as providers of technological solutions. (such a target of companies being traditionally excluded for ERDF intervention in the Murcia region)
The main outcome of the project will be provided at the end of the project, with the analysis of the Key Performance Indicators (KPIs) that will permit the comparison between the SMEs following the both technical arms defined in the project (i.e. Co-creation and business support) or without these added value services.
All the SMEs involved in the project, belonging to control arm or intervention arm will receive the same funding rate to carry out their projects and the same challenge fiche. The only difference will be the added value services that will join the intervention group companies according to the inDemand model (ie. co-creation + business support).
It is a Controlled Randomized Clinical Trial, stratified, non blinded, unicentric and with two parallel branches to study, based on the innovation support model (inDemand Model with co-creation and business support versus inDemand Model without additional support).
External Link(s)

Registration Citation

Citation
Ataz, Rafael , Francisco Javier Lopez and Mario Romero. 2021. "Randomized Clinical Trial (RCT) to test the effectiveness of a new innovation support model ." AEA RCT Registry. October 04. https://doi.org/10.1257/rct.8309-1.0
Experimental Details

Interventions

Intervention(s)
First the recruitment of the SMEs will be carried out by INFO. This is a very important aspect in the RCT, in order to ensure that the sample size is high enough to ensure the validity of the project results. INFO will use all the databases and resources to identify the highest number of potential SMEs. Initially, it is expected that around 40 SMEs will be involved in the project. There will be the same number of companies in both arms. In order to get the highest number of SMEs and increase as much as possible the sample size, the SMEs to be allocated can be placed not only in the Murcia region but also out of the region. This was not foreseen in the initial version of DoA and will permit us to select the best companies and to obtain a better sample size.
The budget limit and current situation with respect to the Covid19 pandemic could make more difficult the participation of SMEs. INFO in a close cooperation with the Large-tractor companies will work to encourage the SMEs involvement.
There will be launched a single call with Innosup-6 budget for SMEs that will apply to provide services to necessities in the fields of innovation, digitisation and response to Covid19 identified by large-tractor companies in the Murcia region. The call results will be classified and the selected projects will be contacted.
The randomization process will be implemented at this point, distributing the SMEs in both arms (intervention and control) and will receive the funding with or without Co-creation and Business Support services. SMEs will carry out their projects according with the inDemand approach, with pre-identified challenges promoted by the Large Companies. Half of the SMEs will execute their projects without additional support, and the other will have access to Co-creation process with the Large Company and will receive a Business support service, helping the SMEs in aspects like internationalization, IPR issues, etc. More details of these aspects are included in the Annex II. Depending of the nature of the projects presented by the SMEs and the necessities that they could have, it will be selected the option that will be applied to each SME, Co-creation or Business support.
At the end of the project, we would compare the results of these companies with inDemand support (co-creation + business support) versus mere investigation of SMEs without that support. Previously, an identification of challenges of large-tractor companies would be carried out and later a single call: challenges without support versus challenges with support. To achieve this, a set of Key Performance Indicators (see point 5) have been identified, concerning aspects like innovation improvement, economic impact, and etcetera.
Intervention Start Date
2021-10-01
Intervention End Date
2022-03-31

Primary Outcomes

Primary Outcomes (end points)
Comparison of economic impact prodecued in the SMEs depending on the group they have been allocated.
Primary Outcomes (explanation)
Indicator Definition Advantages Constraints
Incomes received for the new product or process
Incomes of any kind obtained by the new product or process. Includes incomes produced by the sale of the new product or service, incomes from patent licenses or royalties of any other type • Direct relationship between performance (inDemand or traditional) and the obtained results
• Easy to obtain by the company • The life-cycle of obtaining the indicator can be very long: from the end of the action ( inDemand or traditional) until the incomes can be measured, it can take a long time and remain outside the duration of the inDemand project.
Incomes received from the new product o process discounting development costs Incomes of any kind obtained by the new product or process discounting the development expenses associated with the new product

• Direct relationship between performance ( inDemand or traditional) and the obtained results
• Good measure of the benefit.
• The life-cycle of obtaining the indicator can be very long: from the end of the action ( inDemand or traditional) until the incomes can be measured, it can take a long time and remain outside the duration of the inDemand project.
• The calculation of development costs may not be immediate (a methodology should be given for its calculation)

Industrial or Intellectual Property Rights Generated by the new product or process. Number of patents, utility models, trademarks or copyrights registered by the new product or process. • Easy to obtain
• Short life-cycle of obtaining the indicator • Indirect Indicator. You can register a patent or other IPR and not exploit it economically

Secondary Outcomes

Secondary Outcomes (end points)
Indicator Definition Advantages Constraints
Expenditure on internal R&D 1 Creative work carried out within the company to increase the volume of knowledge and its use to devise new or improved products and processes (including software development).
• Easy to obtain.
• There is a lot of information on this indicator at the sector level, by company size, etc., which would allow comparisons to be made with the sample of companies in the inDemand project • It is an indicator that would include the global of the company, being this developed in the scope of the funds received for the project (inDemand or traditional) or not.
External R&D adquisition)1 The same activities as the previous indicator but carried out by other organizations or public or private research organizations, and purchased by the company.
• Easy to obtain.
• There is a lot of information on this indicator at the sector level, by company size, etc., which would allow comparisons to be made with the sample of companies in the inDemand project • It is an indicator that would include the global of the company, being this developed in the scope of the funds received for the project (inDemand or traditional) or not.
Personnel dedicated to internal R&D activities1 The personnel dedicated to internal R&D includes own and external personnel (external consultancy, freelancers ...) who contribute to the performance of internal R&D tasks and who are fully integrated in carrying out these tasks.
• Easy to obtain.
• There is a lot of information on this indicator at the sector level, by company size, etc., which would allow comparisons to be made with the sample of companies in the inDemand project • It is an indicator that would include the global of the company, being this developed in the scope of the funds received for the project (inDemand or traditional) or not.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Controlled clinical trial, stratified randomized (by sectors), non blinded, unicentric and with two parallel branches to study, based on the innovation support model developed by the company (INDEMAND Model versus traditional model).
This study design ensures homogenization in the characteristics of the companies that will be included in both groups. The randomization ensures that the characteristics of the companies of the traditional branch are very similar to the characteristics of the companies of the INDEMAND branch and we will ensure that the differences obtained at the end of the process will be mostly caused by the model used to finance research in innovation.
In principle, this confers great internal validity to the study. In addition, companies may compete with several research projects but always in the same branch of the study.
Experimental Design Details
Randomization Method
The randomization will be done by public lottery.
Randomization Unit
Randomisation will be done by company (SME), allocated tot he control or intervention group.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
30 SMEs
Sample size: planned number of observations
30 SMEs
Sample size (or number of clusters) by treatment arms
15 SMEs control. 15 SMEs treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials