Significance of Disease Surveillance Report (DSR) in Patient recruitment

Disease surveillance is the systematic and regular collection of information on the occurrence, distribution, and trends for prevalence of disease. It is an essential obligation for early detection of emerging (new) or re-emerging (resurgent) infectious diseases. However, in context of Clinical Research Disease Surveillance is predominantly used to identify site & Investigator according to prevalence of disease for higher and cost effective patient recruitment.

“Generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol”. ClinicalTrials.gov 

Patient recruitment is one of the most imperative task that is need to be performed for conducting a significant clinical research. In clinical research subject recruitment is often stand by as a huge challenge as more than 80% of global trials fail to enroll on time, with 52% delayed by 1-6 months1; this kind of delay can affect company’s commercial standpoint by an unforeseen deficit.

Although in comparison to the western frontier the patient enrollment rate in India is about 3-4 times higher; but as most of the CRO’s are operating at places where clinical studies are already being conducted recruitment is going to be a key hitch because the patient population is shrinking.

Keeping recruitment problem in mind we at Genelife have modified Disease surveillance for Clinical Research purpose. 

Genelife used DSR as a tool for deriving a solution for enhancing the investigator/site selection and patient recruitment process. The primary focus of the survey was to screen unsullied and experienced site/investigator on the basis of patient pool and to understand the disease trend in India. Secondly it was also focused to build empathy with the site/investigator and to spread awareness about the importance of Clinical research and GCP at unexplored or new sites. DSR also used to make out referral sites moreover to make the generation of the feasibility report faster. 

Genelife has conducted a questionnaire survey amongst the investigator to access the patient pool and the disease trends across all regions of India. The Questionnaire was focus on to assess Experience of the investigator in conducting Clinical research, Prevalence of the disease and Number of patient he/she can recruit (with respect to therapeutic area). It also tried to assess the experience and interest of the Doctor/ Investigator/Site in conducting a Clinical Research. 

The DSR was conducted in two phases. In 1st phase therapeutic areas were chosen according to the number of Clinical Trials going on in India & future assumptions along with general physician’s database. The therapeutic areas included in this phase were Cardiology, Dermatology, Gastroenterology, Oncology, Orthopedics and Diabetes. In 2nd Phase Genelife identified the therapeutic area for which we were contacted more, which includes Allergy /Asthma, Endocrinology, Infectious Disease, Metabolic Disorders, Nephrology, Obstetrics/Gynecology, Surgery (Cardiac surgery for medical device), Urology etc. Genelife Clinical Research has isolated India into four demographic region east, west, north and south. A questionnaire was distributed amongst the Investigators/Doctors. 

Genelife has reached almost 800 Investigators/Doctors of different therapeutic area across India evaluating their experience in conducting Clinical Research and accessing the patient pool. Genelife with the help of Disease surveillance survey attempted to access fresh site by providing training to the Doctor who were interested in clinical research but were not trained nor having knowledge of conducting a Clinical Research.

Reference:

1. http://www.pharmabiz.com/article/detnews.asp?articleid=22867&sectionid=50 (December 29, 2010).

Kind Regards,

Iftekhar Kazmi 

Assistant Manager Business Development/Program Manager

GENELIFE CLINICAL RESEARCH

Telephone: +91-(0)22-65242666/555

Email: info@genelifecr.com Website: http://www.genelifecr.com/,

Difference Between Indian GCP & ICH-GCP

1. In Informed Consent Process, As per ICH - GCP any one designated by the investigator to conduct and to sign the consent form. (Section 4.8.8) but in Indian GCP Investigator should sign the form. (Section 2.4.3.1).

2. In IEC section, Indian GCP recommended the maximum no. of IEC member (12-15) but ICH-GCP Maximum number is not detailed. In IEC section, Indian GCP recommended that Member Secretary belongs to the same Institution but ICH- GCP Not recommended.

3. As per Indian GCP Monitor is also responsible for ensuring that CRFs are legible. where ICH-GCP state that Monitor has to verify that the documents provided by the investigator are legible.

4. As per Indian GCP, Study related documents/materials should be safe guarded by the sponsor for 3 years. (Section 3.1.5) but in ICH-GCP the records are linked to marketing approval.

5. Investigator qualifications: The Indian GCP investigator should be qualified as per the requirement of the Medical Council of India (MCI).

6. Investigator and sponsor’s Sops: The Indian guideline mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). Besides, the investigator and his staff have to be aware and comply with SOPs; ICH-GCP expects the investigator to comply with the protocol.

7. Investigators responsibility for data analysis: As per ICH-GCP, when the trial is completed, the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial. In contrast, Indian GCP demands that the investigator should sign and forward the data like Case Report Forms (CRF), results and interpretations, analyses and reports of the study from his/her centre to the sponsor and the ethics committee.

8. Powers of IEC: According to Indian GCP (2.4.2.6), the IEC has power to order discontinuation of a trial if the IEC finds that the goals of the trial have already been achieved mid-way or unequivocal results obtained. As per ICH-GCP, this is the responsibility of independent data-monitoring committee (IDMC).

9. EC Quorum: ICH GCP min of 5 members and Indian GCP min of 7 members.

10. EC Members: Indian GCP gender representation at least 1 women

Progression with Pre- Clinical Studies

With the vision to be a preferred partner by the sponsor in providing complete management to the drug development services; we are working with the unique hallmark of Quality and Innovation. Genelife Clinical Research understands that Pre-Clinical Study is the foremost step to initiate the drug development process.

After playing a significant role in two Clinical studies for US FDA; Genelife has given a fine start with the preclinical Study. We are conducting Ten Pre- Clinical Studies; viz. Acute and Sub Acute studies for the a Inhalation Study, Four intravenous injectable, Five oral formulations. Apart from these Toxicity studies we are also conducting Non-Clinical studies like Capillary Electrophoresis and Stability Study. The Capillary Electrophoresis study we have conducted by Capillary Zone Electrophoresis (CZE). In Capillary Zone Electrophoresis analytes moves in the EOF but separate into bands because of difference in their electrophoretic mobilities. Further to this Capillary Electrophoresis study of a protein molecule. we are looking forward to do conduct another Capillary Electrophoresis of an Alkaloid. Conducting Capillary Electrophoresis study is unique experience as very few CRO's has the capability to conduct Capillary Eletrophorasis study. Now we at Genelife has developed facility for conducting these Studies and will play a vital role in setting up the highest Quality Standard and Expertise.

After these few Pre-Clinical Studies, we have erudite that for perfection one needs experience in the field. We are looking forward for more such preclinical studies and the Clinical Trials of these drugs in near future.

Rahul Bhalla

Clinical Research Associate

Genelife CR on a roll with successful Site Selections

Genelife has given a fine start with its projects. Currently we are selecting five sites for Ulcerative Colitis study and twenty sites for Psoriasis study. The site selection is the initial and very crucial part of successful clinical research conduction. During the site selection visit, the site is identified and observed with the infrastructure and number of patients visited at the site along with the technical discussions of the study with the principal investigator.
The very first stage is to select the city for the study. According to the prevalence of the disease and the type of the study for Ulcerative Colitis, we selected Western Maharashtra, Eastern Uttar Pradesh, Punjab, etc. and for Psoriasis study, we have selected cities in Western Maharashtra, Central Madhya Pradesh, Eastern Uttar Pradesh, and some parts of Andhra Pradesh and in the Northern part of India. The experience gained during the site selection was priceless. The doctors’ approach towards our project was appreciable. We conducted the site selection visits in Western Maharashtra, Central Madhya Pradesh, Eastern Uttar Pradesh and Andhra Pradesh. We faced many problems during the process. While selecting the site, we looked for facilities available at the site, patient recruitment rate, and compliance of ICH-GCP guidelines. We also considered important suggestions from investigators related to protocol of the study, exclusion and inclusion criteria for recruiting the patients for the study. After the few site selections, we learned that along with the experience one becomes perfect in the field. We are looking forward for the site selection in Western India in next week and we would like to take all this experience for our future projects.

Ujwala Nikambe
CRA
Genelife Clinical Research

A Proficient Start at Genelife Clinical Research

April 29, 2010, Genelife Clinical Research has acquired a study on Ulcerative colitis from a leading US based organization. We are managing five sites all along the western and northern part of India. It is a global study and Genelife has to enroll around 150 patients in the recruitment duration of 6 months.

In coming week we are also supposed to start another study on Psoriasis which is again a global, multicentre study involving 20 sites and requires 800 patients in the recruitment duration of 6 months.

Our young and dynamic team of Genelife Clinical Research is looking forward for a successful completion of these challenging projects and prove our-self accurate expert. Our aim is to excel in healthcare field by making the best use of opportunities, overcoming challenges by taking initiatives, hard work and sincerity for growth of the organization.

Kind Regards,

Anila Mannathu
Clinical Research Associate

GENELIFE CLINICAL RESEARCH

33, 34, 37 Ground Floor, Cinewonder Mall, Ghodbandar Road, Thane West-400607. INDIA
Telephone: +91-(0)22-65242666

Mob: +91-(0)9773756671

Work flow at Genelife Clinical Research

Genelife Clinical Research

Genelife Clinical Research is started with the sole objective of reducing the time of drug development process. We at Genelife aspire to become the world's leading knowledge-driven service provider for our all Clinical Trial Participants. The building-block of Genelife Clinical Research is its employee, consultants, investigators along with system, who have passion for Clinical research who share common goals and expectations regarding drug development with our sponsor.

Genelife Clinical Research a newly incepted phase II/IV CRO, also involved in project management of Non-Clinical and BA/BE studies. Genelife Clinical Research has the capability to complete multiple projects on time and in budget in different therapeutic areas. Although a new CRO Genelife Clinical Research is confident of its capabilities and able to match any global CRO in quality and timeline.

Genelife Clinical Research is in the initiative to provide trust based strategic partnership with sponsors. Genelife provides broad-based progression of therapeutic candidates, including Drugs, Biologicals and Medical Devices, from the laboratory through clinical proof. Genelife Clinical Research has built the base with core values of 3 Es.

• Experience: Our diverse team brings experience pool of more than 20 years to deliver the most complaint services
• Enthusiasm: Our young and dynamic team considers the value of each sponsor and equally participates in the product development process
• Excellence: Our only objective to attain excellence in each study makes us unique in industry.

Genelife Clinical Research wishes to initiate collaborative effort with medical device, pharmaceutical and biotech to achieve unparalleled scientific, clinical and business results. Genelife Clinical Research innovates and carries-out sponsors’ programs by utilizing Genelife Clinical Research internal professionals, consultants, investigators as well as leveraging our extended Global Resources. By focusing on Translational Clinical Development, Genelife Clinical Research is fully committed to:

• Fundamentally understanding the “Lab” sciences
• Having the ability to lead IND enablement
• Being second to none in carrying out clinical research

Genelife Clinical Research has created an infrastructure that is based upon some of the most experienced program and project managers, seasoned principal investigators, and Academicians who can smoothly guide any project from the bench to the bedside with unparalleled speed. Working with Genelife Clinical Research will provide the following benefits:

• Higher recruitment rates/ shorter timelines
• Better understanding of your research needs
• Clear and transparent service
• Quality data

Our focus on medical device enables us to understand the competitive and regulatory challenges that are unique to the industry. Price erosion due to competition and increasing delays in DCGI approvals are creating continuous pressure on profit margins. Genelife Clinical Research helps by providing lower costs and faster completion of the programs. Genelife Clinical Research understands these challenges and can facilitate this expansion.

Genelife Clinical Research offers unique access and optimal utilization of opinion leaders, principal investigators, clinics, special subject populations, regulatory venues, and other trial resources. Understanding and leveraging the unique peculiarities of different regulatory venues, longstanding relations with renowned opinion leaders, Principal Investigators, and clinics, as well as in-depth understanding of the patients population pools, are all the components of Genelife Clinical Research's ability to deliver Global clinical research excellence. Our rigorous quality checks and SOPs make our data acceptable to the any regulatory body in the world. Genelife Clinical Research is also undergoing the GCP audit and will get certification by 2nd week of February, 2010 and FDA compliance Audit in the last week of March 2010.

The building-block of Genelife Clinical Research is its employee, consultants, investigators along with system, who have passion for Clinical research who share common goals and expectations regarding drug development with our sponsor. Science & innovation is the key for the union of people from diverse field of clinical research in Genelife Clinical Research.

We at Genelife Clinical Research encourage innovation and provide platform for everybody to share ideas and thoughts for the improvement of system. We work in a flexible & Client Centric system. For each given assignment every body in the organization recognizes their task and works in co-ordination with group in order to achieve personal & organizational goal. In our journey of development and innovation, our active consultants from different fields like translational research, drug discovery, Clinical Research, Pre-Clinical research, knowledge consultancy and R&D provide valuable inputs & suggest corrective action (if required) and guide us.

Our project management team has developed a good network among Investigators/Doctors of tier 2 & 3 cities along with tier 1 cities, which provide an extra mileage over our competitors. We have also created a steering committee of Doctors for different therapeutic areas which help us in reducing the lead time of feasibility as well as project planning in best possible way to beat the expectation of the client. 

Kind Regards,
Dhirendra V. Singh,

Managing Director
GENELIFE CLINICAL RESEARCH
34,35,37 Ground Floor, Cinewonder Mall, Ghodbandar Road, Thane West-400607. INDIA, Telephone: +91-(0)22-65242666 Email: dhirendras@genelifecr.com , info@genelifecr.com Website: http://www.genelifecr.com/