“Ask Dory”- a much needed help to find personalized clinical trials online.

More and more patients are turning to the internet to look for a second medical opinion, or for an experimental drug being tested in clinical studies that could help them if they fail standard drug treatment for their condition. In the past it was usually their specialists who would recommend participation in a clinical trial, or refer the patients to a research hospital nearby where clinical studies were conducted. With the advent of web 2.0 tools though it is becoming more and more common for the individual patients or their families to surf the internet looking for active, recruiting clinical trials that may suit them. In the US patients look up on ‘Clinicaltrials.gov‘ (the NIH-based website), while in Europe the clinical trials’ portal is the ‘EU clinical trials register‘ which was just launched this March. Such websites contain huge amount of information which is often difficult to access and understand for the average patient who is overwhelmed by the maze of information written in scientific and medical jargon. ‘Dory‘ will help the patient to get out that kind of impasse. Dory is an online interactive tool that asks the patients personalized questions and help them find the right clinical trial near them.

Nemo & Dory

I tried that myself, inserting “asthma” as a medical condition. I was then asked to enter my zipcode and how far I would be willing to travel to participate in a clinical study (options range from less than 5 miles to entire country, ie the US). I inserted a middle-way option of less than 50 miles and a zipcode of Marin County (north of San Francisco) and I retrieved 10 clinical trials, subdivided by early and late phase of development. The details of the study are displayed, with the relative mileage to drive and the approximate numbers of hours required, and the name and email of the principal investigator to contact to express interest in participation.
Dory is a start up based in the Bay Area that was awarded 10,000 $ to continue development as a semifinalist prize of the Developer Challenge at the Health 2.0 conference in San Francisco. The competition aims at fostering innovation for projects aimed at using public data for cancer prevention and control, and it is a joint initiative of the National Cancer Institute and America Competes Act. Ask Dory is one of the four semifinalists who are receiving each 10,000 $ plus targeted feedback to develop further their projects and will compete in a second round of the challenge with deadline in November, that will award two semifinalists and 20,000 $ each.
For now Dory is helping only patients based in the US (as it uses data derived from ClinicalTrials.gov), but hopefully other inventive and innovative people will take the model and develop it for a EU-based public, using EU-based data.

PS If you don’t remember, ‘Dory’ is the name of the fish that Nemo used to ask lots of questions, to which Dory cheerfully replied by singing: “Just keep swimming, just keep swimming…

Exclusion from clinical trials for the elderly: protection or discrimination?

Last weekend I flew to Rome to attend the 1st European Expert Forum on Blood Cancer in the Elderly. The symposium, organized by ecancermedicalscience, brought together for the first time haematologists, oncologists and geriatricians from all Europe to discuss strategies to treat in the best possible ways haematological malignancies in elderly patients. While this kind of tumors, eg chronic myeloid leukemia, affects predominantly people over 65 years of age, elderly patients are not treated with the most innovative and targeted drugs as younger patients are.
Several are the misconceptions underlying the status quo for this category of patients, for which -as put with the words with one of the speakers, professor Lodovico Balducci from the Lee Moffett Cancer Centre, Florida- age represents a “risk factor for inadequate treatment” and, as a consequence, worse clinical outcome. For one, the anagraphical age of 65 yo is still used as a cut off to exclude patients from clinical trials. Such an exclusion is neither scientifically -as the biological, and not the anagraphical age is the relevant factor to take into account when deciding which therapy to administer- nor ethically justified, but represents an entrenched clinical routine.
A consensus emerged from the symposium that much needs to be done to eradicate it. Professor Antonio Cherubini (Institute of Gerontology and Geriatrics, Perugia University) and Dr Beatrice Lucaroni from the European Commission presented their data on PREDICT, a project of the 7th European Framework Programme focused on human development and ageing and aimed at increasing participation in clinical trials in the elderly. With the words of the European geriatricians that are members of the PREDICT consortium, they have all too frequently found themselves “in a situation where they are unable to prescribe the best course of treatment with the weight of scientific evidence behind them, due to insufficient evidence from clinical trials. […] In practice, clinicians are left to extrapolate from studies of younger, healthier subjects – a practice fraught with difficulty. An analogous problem has occurred in the paediatric context but research in this domain, is much better developed than for the frail older person“.
Two are the interwined issues to take into account when evaluating participation of the elderly in clinical trial: their ability to give informed consent and the risk of discrimination deriving from exclusion. The elderly patient is a very heterogeneous category, which needs propered tailored assessment and consequent stratigication to form the basis of personalized therapy. Indeed, the elderly patient can be fit and able to receive an aggressive treatment as the adult, or unfit for aggressive treatment and able to receive only a lower dose of treatment, or frail and therefore more vulnerable and in need of palliative care and of a complex and multidisciplinarity management by both the geriatricians and the (haemato) oncologist. On the one hand, the frail patient has often associated co-morbidities such as senile dementia, and is therefore unable to consent to informed consent models as the ones prepared for the unfrail patient. Therefore the frail elderly patient is in a vulnerable condition which deserves special protection. On the other hand, labelling elderly patients per se as vulnerable and excluding them from clinical trials represent a discrimination and an injustice, which can and indeed has negative consequences on prognosis and treatment. This was the message strongly put forward in the patient advocacy session by Giora Sharf, elderly CML survivor and head of the CML Advocates Network, and by Joerg Hasford, founding member of the German Drug Utilization Center. For the future, strategies to implement trial participation in the elderly, while taking care of their reduced autonomy and capacity to consent, need to be developed.

Further reading

Defining old: clinical challenges and changing ideas in haemato-oncology, Insider News, ecancermedicalscience, March 19, 2011.

Cherubini A, Del Signore S, Ouslander J, et al. Fighting against age discrimination in clinical trials. J Am Geriatr Soc. 2010 Sep;58(9):1791-6.

Kumar PS, Katheria K, et al. Evaluating the Older Patient with Cancer: Understanding Frailty and the Geriatric Assessment, CA Cancer J Clin 2010; 60:120-132.

Mallery LH, Moorhouse P. Respecting frailty. J Med Ethics 2011;37:126-128.

PREDICT project for Increasing the Participation of the ElDerly In Clinical Trials

Clinical trials for young oncological patients: a call for action at the European level.

Cancer is a rare disease in children, defined as having a prevalence of less than 50 in 100,000 or an incidence of less than 5 in 100,000 populations per year. Paediatric malignancies account for 1 % of all cancers in humans, and in Europe, 15,000 children are diagnosed with cancer every year. Olivia, 15 yo, survivor of Wilms tumor , reported her experience as a participant in a clinical trial at the International Childhood Cancer Awareness Day, which was held at the European Parliament of February 9, 2011. The event was hosted by MEP Mr Alojz Peterle and organized by the European Parliament in collaboration with the European Society for Paediatric Oncology.

EU Parliament

Olivia’s prognosis was very severe, and she owes her life to the participation in a clinical trial. As paediatric tumors are by definition a rare disease, clinical trials in children require multinational collaboration, which needs to be coordinated at the European level. This is why childhood cancer needs the spotlight and political support, of which the International Childhood Cancer Awareness Day was only a first step. Three were the key take-home messages delivered by Richard Sullivan, Kings Health Partner Integrated Cancer Centre concluding the event:
1) research in paediatric oncology is essential and is required to be strictly intertwined with clinical practice to achieve good outcomes in diagnosis and treatment;
2) research funding is fragile and short time, and needs support at both national and supranational level;
3) in some members state the level of support for young oncological patients is really poor. In the framework of the European Union, this issue becomes a transnational one.
In particular, information on childhood cancers varies considerably across Europe, and access to information influences heavily the access to care, early diagnosis and eventual the outcome of the disease. A poor information can lead to a late diagnosis, which in turn may result to be fatal, as some videos produced by “Jimmyteens TV” show.

Report on New Policies for Childhood Cancer

In order to avoid avoidable tragedies, it is necessary to establish a European common Information Portal aimed at promoting harmonization, enhanced control of information quality, standards of provision and linguistic access for countries with no patient organizations and/or native language information provision. From a broader perspective, there is an urgent need to think innovative in terms of funding for research and treatment in paediatric oncology, as regulation needs to line up and ensure that multinational trial start at the level of the European union. If you are interested in reading more about innovative policies in paediatric oncology in Europe, take a look at the report “‘The State of Research into Children with Cancer across Europe – New Policies for a New Decade”, produced by SIOPE in collaboration with Ecancercoms, a EU-funded project looking at the issues surrounding communication and dissemination of cancer information across Europe.