Restoring invisible and abandoned trials: a call for people to publish the findingsBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2865 (Published 13 June 2013) Cite this as: BMJ 2013;346:f2865
All rapid responses
Doshi and colleagues are concerned, understandably, at the use of control injections in vaccine trials, that are not true placebos. (1)
Perhaps there would be even more concern if people understood that such practices are not unusual, in vaccine trials.
The nature of any control injections, in vaccine trials, is sometimes difficult to ascertain, as Doshi and colleagues’ letter suggests.
In his chapter on vaccine safety, Moskowitz lists the sixteen vaccines that were mandated in the USA, in 2017. (2)
Four of the vaccines were subject to trials that used unspecified “placebos” as controls.
Five of the vaccines had no record of controlled safety studies.
Six of the vaccines were subject to trials where other vaccines were given as the control injections.
In the case of one vaccine, the control injection was a “placebo”, phenol 0.25%.
2 Richard Moskowitz, MD, Vaccines, a reappraisal. Skyhorse Publishing, 2017. (pp34 et seq)
Competing interests: No competing interests
We write to issue a call to action to restore the reporting of multiple trials in Merck’s clinical development program for quadrivalent human papillomavirus (HPV) vaccine (Gardasil) vaccine. These trials include:
FUTURE II (NCT00092534), published as FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915–27.
FUTURE III (NCT00090220), published as Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24–45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949–57.
These highly influential publications (totalling over 1300 citations together, according to publishers’ websites) report the results of two pre-marketing clinical trials of Gardasil that involved over 15,000 women between the ages of 15 and 45.[1,2] These were pivotal trials that underpin the approval of the vaccine.
However these trial publications have incompletely reported important methodological details and inaccurately describe the formulation that the control arm received, necessitating correction of the record.
We intend to restore the written record for these trials in accordance with the principles of the Restoring Invisible and Abandoned Trials (RIAT) initiative, of which we are founders.
Our rationale for correcting the record
Both trial publications state that they are reports of “placebo-controlled” trials.[1,2] However participants in the control arm of these trials did not receive an inert substance, such as saline injection. Instead, they received an injection containing amorphous aluminium hydroxyphosphate (AAHS), a proprietary adjuvant system that is used in Gardasil to boost immune response.
The use of a comparator that was neither an inert substance nor an efficacious vaccine against another disease demands explanation. The clinical rationale for such a decision is unclear, as the trial arms do not mimic the real life choice of deciding whether or not to receive HPV vaccine, and it is incompatible with established ethical principles regarding the use of placebo in vaccine trials. However, in at least two key trial publications, of the FUTURE II and FUTURE III trials, the rationale for the use of AAHS-containing control is unstated. Trial registration entries for these trials also lack a rationale on the selection of this control.
Furthermore, because AAHS is not inert, the choice of AAHS-containing control complicates the interpretation of efficacy and safety results in trials. While there is no evidence or reason to believe that AAHS adjuvant can induce efficacy on its own without the HPV virus like participles (VLPs) present in the approved vaccine, AAHS is understood to have a harms profile. For example, in a phase 2 study testing multiple doses of potential Gardasil formulations (V501-007), the manufacturer included two active AAHS-containing adjuvant dose arms, “for appropriate safety comparisons.” Concerns about the safety profile of AAHS-containing control and the impact on interpretation of results is also evidenced by the fact that the FDA directed Merck to conduct a 6 month safety study comparing 3 doses of Gardasil against a non-aluminum containing placebo, according to the company’s submission to Japanese regulators. At the time of Gardasil’s 2006 approval in the US, trial V501-018 was the only study to compare Gardasil with a non-aluminum containing placebo, and the FDA medical officer referred to the control used in this trial as “true placebo,” in contrast to the control used in other trials.
The FUTURE II and FUTURE III trial publications however do not discuss how AAHS-containing control could affect the interpretation of results.
We consider the omission in journal articles, of any rationale for the selection of AAHS-containing control, to be a form of incomplete reporting (of important methodological details), and believe the rationale must be reported. We also consider that use of the term “placebo” to describe an active comparator like AAHS inaccurately describes the formulation that the control arm received, and constitutes an important error that requires correction. If trial participants were told they could receive “placebo” (widely defined as referring to an “inactive”[10,11] or “inert” substance) without being informed of all non-inert contents of the control arm injection, this raises ethical questions about trial conduct as well.
Scope of our restoration
After documenting that these deficiencies in reporting were not confined to a single study, but at least applied to two Phase 3 trials in the Gardasil evidence development program, we have decided to systematically correct the record for all Gardasil and Gardasil 9 trials with standalone aluminum-containing control arms. We may therefore discover additional trials in need of restoration for the same reason, and we will include this as part of our work.
Our population of trials potentially eligible for restoration is defined as all clinical trials for which we have obtained clinical study reports (CSRs). At present, this population is limited to data received from the European Medicines Agency (EMA) in response to a request by one of the team members (TJ) for all CSRs for Gardasil and Gardasil 9, lodged in May 2014. The process of obtaining CSRs has been previously described in an Index study and Analysis article. All trials for which CSRs of Gardasil and Gardasil 9 vaccine trials were obtained by 1 November 2018 are potentially eligible for inclusion in this restoration.
Following a 2018 ruling in Canadian Federal Court, we anticipate having access to all CSRs for Gardasil and Gardasil 9 and may use these data from Health Canada instead of--or in addition to--what we have received from EMA, depending on what data are received.
Our holdings include the trial protocol, CSR main body, and informed consent form used during participant recruitment. We also hold correspondence with regulators and manufacturers in which the topic has been discussed.
Questions our restoration aims to answer
1. Has the rationale for using a control arm formulation that contained the aluminium-containing adjuvant known as AAHS been documented? If so, what was it?
2. What was contained in the control arm formulation?
3. How was the control arm formulation described across trial publications, registry entries, CSRs, and informed consent forms?
4. What are the consequences of such a choice for participants and how might it affect the interpretation of the trial results?
1. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915–27.
2. Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24–45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949–57.
3. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865.
4. Rid A, Saxena A, Baqui AH, Bhan A, Bines J, Bouesseau M-C, et al. Placebo use in vaccine trials: recommendations of a WHO expert panel. Vaccine. 2014 Aug 20;32(37):4708–12.
5. Petrovsky N. Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs. Drug Saf. 2015 Nov;38(11):1059–74.
6. Villa LL, Costa RLR, Petta CA, Andrade RP, Ault KA, Giuliano AR, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271–8.
7. MSD. 2.5 臨床に関する概括評価 [2.5 Clinical Summary] [Internet]. [cited 2018 Nov 29]. Available from: http://www.pmda.go.jp/drugs/2011/P201100122/170050000_22300AMX00600000_G...
8. Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201–9.
9. Miller N. Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc [Internet]. 2006 [cited 2018 Nov 29]. Available from: http://wayback.archive-it.org/7993/20170723091811/https://www.fda.gov/do...
10. Merck. Frequently asked questions [Internet]. [cited 2017 Aug 24]. Available from: http://www.merck.com/clinical-trials/frequently-asked-questions.html
11. National Library of Medicine. Glossary of Common Site Terms [Internet]. ClinicalTrials.gov. 2018 [cited 2018 Nov 29]. Available from: https://clinicaltrials.gov/ct2/about-studies/glossary
12. Jørgensen L, Gøtzsche PC, Jefferson T. Index of the human papillomavirus (HPV) vaccine industry clinical study programmes and non-industry funded studies: a necessary basis to address reporting bias in a systematic review. Syst Rev. 2018 Jan 18;7(1):8.
13. Jørgensen L, Doshi P, Gøtzsche P, Jefferson T. Challenges of independent assessment of potential harms of HPV vaccines. BMJ. 2018 Sep 24;362:k3694.
Competing interests: The Laura and John Arnold Foundation funds the RIAT Support Center which supports the salaries of Doshi, Jefferson, Jones, Bourgeois, Spence, Shamseer (until 2018), and Hong. In addition: Peter Doshi has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the Laura and John Arnold Foundation (2017-20), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National Institute for Health Research (2011-14); and is an editor at The BMJ and unpaid member of the Reagan-Udall Foundation for the FDA. Tom Jefferson (TJ) was a recipient of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza. In addition, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in litigation related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage (including the vaccine Pandemrix (2015-2017) and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013).In 2014 he was retained as a scientific adviser to a legal team acting on oseltamivir. TJ has a potential financial conflict of interest in the drug oseltamivir. In 2014-16, TJ was a member of three advisory boards for Boerhinger Ingelheim. TJ was holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. Between 1994 and 2013, TJ was the coordinator of the Cochrane Vaccines Field. TJ was a co-signatory of the Nordic Cochrane Centre Complaint to the European Medicines Agency (EMA) over maladministration at the EMA in relation to the investigation of alleged harms of HPV vaccines and consequent complaints to the European Ombudsman. TJ is co-holder of a John and Laura Arnold Foundation grant for development of a RIAT support centre (2017-2020) and Jean Monnet Network Grant, 2017-2020 for The Jean Monnet Health Law and Policy Network. TJ is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018-2022). Mark Jones was a co-investigator on a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza; was a co-recipient of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews; and is a paid consultant on a John and Laura Arnold Foundation grant for development of a RIAT Support Center (2017-2020). LS, HL, FB, KH: no competing interests to declare. OS was a recipient of a Maryland CERSI Scholar award from the Food and Drug Administration (grant #1U01FD005946).
Since launching, BMJ Open has aimed to increase transparency in publishing. In an effort to improve clinical practice, we fully support initiatives that help complete the publication record. As such, we fully support the RIAT initiative and are willing to accept submission of RIAT manuscripts.
Competing interests: No competing interests
Call to action: RIAT reanalysis of Forest Laboratories CIT-MD-18: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Citalopram in Children and Adolescents with Depression
I write to issue a call to action to restore the reporting of CIT-MD-18: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Citalopram in Children and Adolescents with Depression
CIT-MD-18, IND Number 22,368, was one of two RCTs used in the 2009 FDA approval of escitalopram in the treatment of adolescent depression, however, citalopram failed to outperform placebo on the protocol-specified primary and secondary outcomes measures. The study was conducted between 1999 and 2002 and was designated as a 9-week, 20-site, randomized, double-blind comparison of the safety and efficacy of citalopram verses placebo in children age 7-11 and adolescents age 12-17 with major depressive disorder. It was designated a Phase III registration trial supporting an FDA indication for depression in pediatric patients. 174 patients were enrolled in the study, 89 in the citalopram group and 85 in the placebo group. The study protocol specified that the primary efficacy measure was the change from baseline to week 8 on the Children’s Depression Rating Scale-Revised (CDRS-R) total score. Protocol-specified secondary efficacy measures included the Clinical Global Impression Severity and Improvement Subscales, Kiddie Schedule for Affective Disorders and Schizophrenia―Depression Module, and Children’s Global Assessment Scale.
The report of CIT-MD-18 was published in 2004.  Jureidini, Amsterdam and McHenry have argued elsewhere that study CIT-MD-18 has been misreported.  Other researchers before us have also found serious problems with the published article.  CIT-MD-18 is still cited as a positive RCT in some prescribing guidelines for citalopram use in pediatric depression. As a result, I am submitting the rapid response as a call to action to restore the record.
Forest’s CIT-MD-18 is easily compared to GlaxoSmithKline’s study 329 for pharmaceutical industry manipulation facilitated by ghostwriting.  Study 329 was one of the first RCTs subjected to RIAT reanalysis. 
The status of the data de-classified from litigation: 42 pages of study protocol, 15 pages of CSR, Internal Forest Email correspondence.
Forest Laboratories was acquired by Allergan which is now in the process of being acquired by Activas.
Research questions include:
*To what extent was safety data accurately reported?
*To what extent were secondary outcome measures misreported prior to week 8?
*What was the correct effect size?
*Which sites were affected by the dispensing error?
*Which site investigators were unblinded by the dispensing error?
*How did the unblinding affect the calculation of the primary outcome analysis?
*What were the original sample size estimates performed for the determination of statistical significance for drug versus placebo?
*What power estimates were used to obtain the protocol-designated sample size?
* What subject samples were used to make the drug versus placebo estimates (e.g. drug versus placebo for the entire sample of children plus adolescents, or drug versus placebo for individual sub-groups, i.e., children or adolescents)?
*Assuming the sample size needed to show statistically significant superiority of drug over placebo was based upon a total sample comprising both children plus adolescents, how did Forest handle the ‘interaction’ effect in their protocol-specified ANCOVA analysis which showed no statistically significant benefit of drug over placebo in the children subgroup?
*If the ANCOVA interaction effect did demonstrate the null for children (versus adolescents), was this based upon a power (i.e., sample size) comprising both subject sub-groups, in which case neither subgroup may have demonstrated true drug versus placebo superiority?
 Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. Am J Psych 2004, 161: 1079-1083.
 Jureidini J, Amsterdam J, McHenry L. The citalopram CIT-MD-18 pediatric depression trial: A deconstruction of medical ghostwriting, data manipulation and academic malfeasance. Int J Risk Saf Med 2016, 28: 33-43.
 Martin A, Gilliam WS, Bostic JQ, Rey JM. Letter to the editor. Child psychopharmacology, effect sizes, and the big bang. Am J Psych 2005; 162 (4): 817.
 Sussex Partnerships NHS, Guidance on the use of antidepressants in children and adolescents, Version 2, January 2014.
 Amsterdam J, McHenry L, Jureidini J. Industry-corrupted psychiatric trials. Psychiatr Pol 2017, 51: 993-1008.
 Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015, Sep 16;351:h4320.
Competing interests: Research consultant to the law firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California, USA
We have identified an unpublished trial: sertraline trial 050-113: The Effects of Sertraline Compared with Placebo on the Body Weights of Patients with Non-Insulin-Dependent Diabetes Mellitus.
Although the trial finished in 1992, given the widespread use of sertraline (Zoloft) we believe this to be a very important trial. Its publication would benefit patients and prescribers.
One of us (TS) has access to the main body of the clinical study report and we will be writing to the study sponsor (Pfizer) inviting them publicly declare, within 30 days, their intention to publish the study within the next 365 days.
We are also looking for interested parties to undertake restoration of the trial for which we can provide assistance under the RIAT initiative and financial support.
Competing interests: The Laura and John Arnold Foundation is a philanthropic organisation that supports the salaries of PD and TJ. For a complete list of PD & TJ’s disclosures, please see http://restoringtrials.org/about-us/. PD is also an associate editor at The BMJ. TS considered the main body clinical study report for this trial for her PhD research, which was fully funded by the Laura and John Arnold Foundation.
I write to issue a call to action to restore the reporting of the TADS: Treatment for Adolescents with Depression Study , registered as ClinicalTrials.gov Identifier: NCT00006286 (https://clinicaltrials.gov/ct2/show/NCT00006286).
TADS was an important and influential multicenter randomized controlled trial, sponsored by the US National Institute of Mental Health (NIMH). The trial was conducted at 13 US academic and community clinics between 2000 and 2003. Its stated aim was to contrast the degree and durability of improvement obtained across four treatment strategies for 439 12-17-year-olds with a DSM-IV diagnosis of MDD: fluoxetine alone (n=109), cognitive-behavior therapy (n=111), both fluoxetine and cognitive-behavior therapy combined (n=107), and pill placebo (n=112).
TADS has been controversial since its publication. Its methodology has been criticized for not including a comparison of CBT-plus-fluoxetine versus CBT-plus-placebo , and because two of the study arms were unblinded . The main published reports [4,5,6] were criticized for reporting post hoc outcomes  and for discrepancies between the abstracts and the bodies of papers. More recently, it has been reported that the suicide risk in TADS was misreported in the trial reports, downplaying the risk of suicide in patients taking fluoxetine.
CEMH (www.ua.edu.au/cemh) currently have available to us all data tables from the TADS study, as provided by NIMH. We are currently seeking anonymised Clinical Record Forms from NIMH, but whether or not these are provided, CEMH intends to carry out a RIAT reanalysis of the available data unless the authors and/or sponsors undertake to do so.
Additional research questions will include:
* What were the harms (including deterioration of depression scores) and benefits of fluoxetine in this population?
* Was there a "squeezing the middle" effect?
* Was there an all-or-none responder effect or a smaller benefit for more patients?
* Were there baseline predictors of benefits or harms?
1. The TADS Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. JAMA 2004,292: 807-820.
2. Jureidini J, Tonkin A, Mansfield P. TADS study raises concerns. BMJ 2004,329:1343.
3. Mansfield P, Raven M, Jureidini J. Depressed youth, suicidality and antidepressants. MJA 2005,183(5):275.
4. March J, Silva S, Vitiello B, et al. The Treatment for Adolescents with Depression Study (TADS): Methods and message at 12 weeks. Journal of the American Academy of Child and Adolescent Psychiatry 2006,45: 1393-1403.
5. Curry J, Rohde P, Simons A, et al. Predictors and moderators of acute outcome in the Treatment for Adolescents with Depression Study (TADS). Journal of the American Academy of Child and Adolescent Psychiatry 2006,45:1427-1439.
6. The TADS Team. The Treatment for Adolescents with Depression Study (TADS): Long-term effectiveness and safety outcomes. Archives of General Psychiatry 2007,64:1132-1144.
7. Jureidini J, McHenry L. Key opinion leaders and pediatric antidepressant overprescribing. Psychotherapy & Psychosomatics 2009,78(4):197–201.
8. Högberg G, Antonuccio D, Healy D. Suicidal risk from TADS study was higher than it first appeared. Int J Risk Saf Med. 2015;27(2):85-91
Competing interests: No competing interests
About: ...."We have access to around 178 000 pages of previously confidential company research documents (table 1⇓, box). For drugs such as paroxetine, quetiapine, and gabapentin, litigation over illegal off-label marketing put thousands of pages of trial reports in the public domain. " .... Expert search terms (PubMed - Dec 24, 2014)
Studies completed before Jan 2011: 290
Not found on PubMed → 212 (73%)
Found on PubMed → 78 (27%) → 131 articles
How many unpublished today? Does it matter!? Quetiapine database of human studies. figshare. Figure. https://doi.org/10.6084/m9.figshare.1278855.v1
Competing interests: previously disclosed.
A message to people responsible for abandoned or misreported trials: you will be published or retracted.
Deadline in this article passed several months ago (June 14, 2014).(1)
- People with abandoned trials: you will be published.
- People with misreported trials: you will receive several requests of retractions. Please remember that your paper is not sacred.(2)
1. Doshi Peter, Dickersin Kay, Healy David, Vedula S Swaroop, Jefferson Tom. Restoring invisible and abandoned trials: a call for people to publish the findings BMJ 2013; 346:f2865. http://dx.doi.org/10.1136/bmj.f2865
2. Marcus A, Oransky I. Science publishing: The paper is not sacred. Nature 2011;480:449–50. http://www.nature.com/nature/journal/v480/n7378/full/480449a.html
Competing interests: Non-financial: http://chaoticpharmacology.com/disclaimer-coi/
I have got a problem. I guard the definitive results of a trial that was published only as an abstract in the European Cancer Conference (ECCO-8) in 1995 (Lacave AJ, Arranz F, Rubiales AS, Buesa JM, Estrada E, Esteban E, et al. Aminoglutethimide + hydrocortisone vs megestrol acetate as second and third line treatment in advanced breast cancer: a phase III study. Eur J Cancer 1995; 31A (Suppl. 5): S79 ; abstract 362). Who was then my “boss” (and first author) asked me and a fellow resident to collaborate recovering data of patients, filling a data base, and presenting final results. After ECCO-8, I imagined that “senior” authors would be willing to send this trial to be published at a peer-reviewed journal of Oncology. As I kept one of the digital copies of results, I decided to be ready writing a provisional version of the paper. But they forget it or, may be, they were afraid of critics. I do not know. Anyway, as I can know, they never send it to publication. After my residency period, I went to work as an Oncologist in another Hospital and eventually, I did forget this paper. More than ten years later when I found my proud provisional version as an archive lost in my personal computer.
As time passed by, a majority of authors (including who promoted the work) no longer work in this hospital.. I wonder if nowadays these final results have any moral owner … I do not feel myself able to act on my own sending this work looking for an amnesty of old trials. I understand that we authors share a responsibility to publish these final results (even when the trial, as it is the case, was designed to answer a questions that have become irrelevant), but… may I do it?, do I need any external approval?... and, if so, who should give it?
Competing interests: No competing interests
Publication bias is a serious problem in medical research. BioMed Central, the open-access publisher, is fully committed to supporting and facilitating publication of all trial results in order to complete the scientific record. Many of our journals, including all those in the Medical Evidence Portfolio, actively encourage the publishing of all research results, positive and negative, in addition to trial protocols.
Making the results of all clinical trials accessible to researchers, clinicians and the public not only promotes transparency in clinical research, it also ensures that all the evidence is available for informed clinical decision making. However, actually getting all the results published is quite another thing.
With the Restoring Invisible and Abandoned Trials (RIATs) initiative, Doshi and colleagues have proposed a pragmatic method of getting unpublished, distorted or abandoned trials published. In the article they propose a 12-month ‘grace period’ to allow the original triallists to publish their articles and now, at the halfway point of this period, the Editors-in-Chief of Trials and the Journal of Negative Results in BioMedicine have written an open-letter in support of the RIAT initiative to almost 200 publications managers in large pharmaceutical companies to encourage them to declare their intent to publish their results. Read the letter here.
Competing interests: No competing interests