La gestione clinica della maggior parte delle patologie che interessano la popolazione generale adulta viene condotta a livello ambulatoriale dal Medico di Medicina Generale. Patologie quali ad esempio , l’influenza, le infezioni delle alte vie respiratorie, l’ipertensione arteriosa, la dislipidemia, il sovrappeso, rappresentano situazioni osservate, gestite e trattate quasi esclusivamente nel territorio. A ciò, si va ad aggiungere la co-gestione con lo specialista ed il monitoraggio dei pazienti con malattie croniche e degenerative.
La possibilità di svolgere sperimentazioni cliniche nel territorio offre numerosi vantaggi:
Il territorio con i suoi operatori medici e le sue strutture sanitarie potrebbe recuperare così centralità oltre che nella gestione clinica anche nella ricerca, quando questa è rivolta al miglioramento della salute delle persone attraverso interventi che vengono effettuati a domicilio e negli ambulatori.
Allora come mai dalla fine del 2001 , anno in cui in Italia entra in vigore un decreto che permette anche ai medici di medicina generale di fare ricerca clinica , cioè di sperimentare, secondo regole ben definite, l’efficacia di nuovi farmaci o di nuove strategie terapeutiche, di fatto gli studi clinici condotti in medicina generale si limitano a poche unità?
Perché le aziende farmaceutiche , che investono centinaia di milioni di euro ogni anno per finanziare la ricerca clinica negli ospedali ed università italiane non sono interessate alla sperimentazione clinica in medicina generale?
Molti possono essere i motivi per cui si puo’ parlare di fallimento nel coinvolgimento dei medici di medicina generale nel complesso processo dello sviluppo clinico dei farmaci.
Tra questi almeno tre vanno ricordati :
In questo contesto e come risposta concreta alla domanda del titolo di questa comunicazione, la SIICP assieme ad Exom Group, la prima Digital Contract Research Organization (CRO), che utilizza le piu’ avanzate tecnologie digitali e mobile, per la conduzione degli studi clinici, ha deciso di attivare un suo Centro Ricerca Clinica , in grado di offrire i seguenti vantaggi competitivi :
“Questa iniziativa – commenta il Dr.Vincenzo Contursi, attuale presidente della SIICP- rappresenta una grande opportunità per la crescita culturale-scientifica della nostra giovane societa’ e per la medicina generale italiana per dimostrare non solo l’importanza , ma anche la piena fattibilità di condurre sperimentazioni cliniche di qualità nel territorio, come gia’ avviene da anni e con successo in molti paesi europei “
Il Dr.Luigi Visani , Amministratore Delegato di Exom Group srl , afferma – “La creazione di questa partnership tra la SIICP e la nostra azienda, e’ la prova di come anche in Italia, combinando eccellenze e competenze mediche, scientifiche, tecniche, regolatorie ed organizzative, con le piu’ avanzate tecnologie digitali , si possono creare sistemi organizzativi ed operativi in grado di competere a livello internazionale e di fornire servizi e risultati di estrema qualità ed affidabilità“.
Clinical research in general practice is fundamental to ensure patient safety and efficient patient care. Recently, there has been increasing awareness of the need for clinical trials in primary care settings, or extension of translational research projects into everyday primary care, which can provide evidence with significant impact on public health
In the USA, according to the Department of Health around 90% of people’s contact with the NHS is in primary care so it makes sense that more research should be taking place in a primary care setting. Indeed the number of patients participating in research studies conducted in primary care has constantly increased over the last few years; reaching nearly 150,000 in 2010/11.
About 90% of all drug prescriptions for outpatients are issued in general practice . Patients in general practice are more likely to have less severe disease, and more undifferentiated symptoms than selected patients in secondary or tertiary health care, however, multi-morbidity is common . If a study population in a drug trial differs significantly from the population where the drug is most likely to be prescribed, the external validity of the trial may be impaired . To avoid this uncertainty, many have argued that more clinical drug trials should be conducted in primary care settings to ensure that the benefits are proportionate to the risks and costs of the treatment for patients in general practice [4,5]. Clinical drug trials may serve different purposes, from research of effectiveness, to marketing .
A recent publication by Anja Maria Brend from the University of Oslo (Norway) (7) examined a 10-year retrospective series of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). Number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion has been analyzed.
Out of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%).
Another study from 2000 found that 84% of GPs in a part of England had been involved in research, 48% mainly in clinical trials (8).
On the contrary , in Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, even if , recent developments in the research landscape are encouraging (9).
Conducting clinical trials in general practice still poses some typical challenges, like difficulties with study logistics and patient recruitment in a large number of small trial sites, however their real life value is widely recognized and strongly envisaged.
The new challenge for general practice to increase the number of clinical trials either industry sponsored but also researcher initiated clinical drug trials .
Exom Group srl, with its contract research division, has activated a new initiative named EUCOR-GP (www.eucorgp.net), aiming at creating an European based network of selected General Practitioners educated, trained and certified for the conduction of clinical trials.
The Eucor.gp network will represent a competitive and qualified European group of GPs from various European countries , with a proven knowledge of clinical research methodology and ready to be involved in national and international studies on drugs , devices and medical interventions.
In order to be an Eucor.gp member, each GP has to provide a list of information regarding his practice and clinical expertise, as well to undergo a specific GCP (Good Clinical Practice) training course.
After the final training assessment test has been positively passed , the GP will be certified as GPI (General Practitioner Investigator).
Exom Group as the project promoter and coordinator, will have the right to raise business opportunities through the promotion of Eucor-gp to any pharma , biotech and device company potentially interested in conducting clinical trials in the primary care setting. Moreover Exom Group will be responsible for providing all the services needed for the conduction of a clinical trial such as:
a) GPs selection and training
b) Medical Writing
c) Ethics Committes submissions
d) Study management and monitoring
e) Medical Monitoring
f) Data Management and Statistics
g) Study drugs and materials distribution.
1) Hunskår S: Allmennmedisin [General Practice]. 2nd edition. Oslo, Norway: Gyldendal Norsk Forlag; 2003.
2) Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B: Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet 2012, 380:37-43.
3) Rothwell PM: External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet 2005, 365:82-93.
4) Gagyor I, Bleidorn J, Wegscheider K, Hummers-Pradier E, Kochen MM: Practices, patients and (im)perfect data – feasibility of a randomised controlled clinical drug trial in German general practices. Trials 2011, 12:91.
5) Hummers-Pradier E, Beyer M, Chevallier P, Eilat-Tsanani S, Lionis C, Peremans L, Petek D, Rurik I, Soler JK, Stoffers HE, Topsever P, Ungan M, van Royen P: Series: The research agenda for general practice/family medicine and primary health care in Europe. Part 4. Results: specific problem solving skills. Eur J Gen Pract 2010, 16:174-181.
6) Laake P, Benestad HB, Olsen BR: Research Methodology in the Medical and Biological Sciences. London, UK: Academic Press; 2007.
7) Brend AM, Jensen KB, Kloning A, Straand J, : Clinical drug trials in general practice: a 10-year overview of protocols , Trials 2013, 14:162 doi:10.1186/1745-6215-14-162
8) Jowett SM, Macleod J, Wilson S, Hobbs FD: Research in primary care: extent of involvement and perceived determinants among practitioners from one English region. Br J Gen Pract 2000, 50:387-389.
9) Hummers-Pradier E, Bleidorn J, Schmiemann G, Joos S, Becker A, Altiner A, Chenot JF, Scherer M, : General practice-based clinical trials in Germany – a problem analysis . Trials. 2012; 13: 205.