Response RatesNCT02569411

Contacting Authors to Retrieve Individual Patient Data

A study testing Financial Incentive in people with Response Rates, run by Unity Health Toronto.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD Read more about this study

Who is it for?: Any age
Conditions the study is for: Response Rates
What is being tested?: Financial Incentive
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: No sites listed yet
Study dates: 10 Jun 2016to 28 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Corresponding authors of RCTs included in our previous and updated systematic reviews

Who cannot join

None listed.

About this study

Official title: Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial

Conditions: Response Rates
Being tested: Financial Incentive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Financial IncentiveOther
money

Study groups in NCT02569411
Study group	Role	What they receive
No Incentive	No intervention	Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
Incentive	Experimental	Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive. Receives: Other: Financial Incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Authors Who Provided Complete IPD
We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Measured: June 2016 - October 2016

Secondary outcomes (2)

Time Taken to Obtain the IPD Between Initial Request and Authors' Provision
We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Measured: June 2016 - October 2016
The Completeness of the IPD Received
We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Measured: June 2016 - October 2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201628 Feb 2018

First posted6 Oct 2015 (estimated)
Study start10 Jun 2016
Primary completion28 Feb 2018
Study completion28 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Response RatesStudies of the same condition, open and under way.
More trials run by Unity Health TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02569411
Sponsor's protocol ID: 15-240c
Status last verified: Jun 2020
First submitted: 30 Sep 2015
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

Veroniki AA, Ashoor HM, Le SPC, Rios P, Stewart LA, Clarke M, Mavridis D, Straus SE, Tricco AC. Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol. 2019 Sep;113:176-188. doi: 10.1016/j.jclinepi.2019.05.031. Epub 2019 May 30.
PubMed 31153977
Veroniki AA, Straus SE, Ashoor H, Stewart LA, Clarke M, Tricco AC. Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial. Trials. 2016 Mar 15;17(1):138. doi: 10.1186/s13063-016-1238-z.
PubMed 26975720

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
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PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
RecruitingPhase 2
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
Active, not recruitingPhase 2/3
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
RecruitingPhase 4
Treating Young Children With Attention Deficit Hyperactivity Disorder
Attention-Deficit/Hyperactivity Disorder (ADHD)

All Response Rates trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02569411
Acronym / sponsor ID: 15-240c
Conditions: Response Rates
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Unity Health TorontoUniversity, hospital or other
Study start: 10 Jun 2016 (actual)
Primary completion: 28 Feb 2018 (actual)
Study completion: 28 Feb 2018 (actual)
First posted: 6 Oct 2015 (estimated)
Results: Posted 1 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
No Incentive	No intervention	–Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
Incentive	Experimental	Other: Financial IncentiveThose allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Corresponding authors of RCTs included in our previous and updated systematic reviews

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Financial Incentivemoney	Other	Incentive

Primary outcome

Proportion of Authors Who Provided Complete IPD
Time frame: June 2016 - October 2016
We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.

2 secondary outcomes

Time Taken to Obtain the IPD Between Initial Request and Authors' Provision
Time frame: June 2016 - October 2016
The Completeness of the IPD Received
Time frame: June 2016 - October 2016

Results and safety

Results posted to the registry on 1 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Incentive (Control)	65	0
Financial Incentive (Intervention)	64	0

Primary outcome: Proportion of Authors Who Provided Complete IPD

Time frame: June 2016 - October 2016. Count of participants. Unit: Participants

Measure	No Incentive (Control) n = 65	Financial Incentive (Intervention) n = 64
Value	0	0

Population analysed: None of the authors in either arm shared individual patient data from their study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable. This study is non-clinical and so adverse event data was not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Incentive (Control)	0 of 0	0 of 0	0
Financial Incentive (Intervention)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31153977Veroniki AA, Ashoor HM, Le SPC, Rios P, Stewart LA, Clarke M, Mavridis D, Straus SE, Tricco AC. Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol. 2019 Sep;113:176-188. doi: 10.1016/j.jclinepi.2019.05.031. Epub 2019 May 30.
Derived from this study: PubMed 26975720Veroniki AA, Straus SE, Ashoor H, Stewart LA, Clarke M, Tricco AC. Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial. Trials. 2016 Mar 15;17(1):138. doi: 10.1186/s13063-016-1238-z.

Related trials for Response Rates

RecruitingPhase 4
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency
RecruitingPhase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
RecruitingPhase 2
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
Active, not recruitingPhase 2/3
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
RecruitingPhase 4
Treating Young Children With Attention Deficit Hyperactivity Disorder
Attention-Deficit/Hyperactivity Disorder (ADHD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Financial Incentive in people with Response Rates, run by Unity Health Toronto.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Authors Who Provided Complete IPD (time frame: June 2016 - October 2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569411, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.