Investigator Portal: a new wave in translational research

There are several new IT enabled services being currently explored in the clinical research space to make operations seamless with a focus on high quality of data and regulatory compliance. Dr Ankasha Tejam and Dr Suguna Nandgaonkar consultants, Healthcare and Life Science Practice, Infosys Consulting highlight the benefits of an Investigator Portal as a database of translational research knowledge

The most basic needs of all human is need to understand and be understood. Best way to understand people is to listen to them - Ralph Nichols Several features contribute to listening to an individual's specific needs and bridging gaps and building effective communication. Patients who feel they've been heard and cared are more likely to follow doctors' orders and have better treatment outcomes. Constant follow up and communication with patients is worth the investment in time and energy with present days patient requirements. Thanks to IT advancements which help clinicians keep track of their patients at anytime with multiple channels of communications.

Pharmaceutical companies develop and launch new drug molecules through extensive clinical research providing documented evidence for the safety and efficacy of the drug molecule in patients for the targeted disease area. The clinical research is conducted with the assistance of clinical investigators highly specialised in treating a particular disease. Active involvement and contribution of investigators is a critical factor for the success of a clinical trial.

The pharma companies look forward to strategic partnerships with qualified clinical investigators with a proven track record for patient enrollment targets and successful completion of clinical studies. The pharma companies also work hard to strengthen these partnerships to ensure participation in future clinical trials to meet companies' clinical research objectives.

A collaborative Investigator Portal is another interesting initiative towards efforts in strengthening relations with clinical investigators. Pharma companies are leveraging the best of technology platforms to improve their clinical operations. However, technology enablement only at the sponsor level will not ensure end to end operational success. Extending these technology benefits to investigators who are playing a crucial and major role right from clinical trial design, initiation to closure is also equally important. Pharma organisations are trying hard to close this technology gap between themselves and various investigator sites. The establishment of long term partnerships will help the pharma organisations in the continual use of the best and qualified investigators and reduce efforts on new site identification.

An interactive and collaborative Investigator Portal will serve this purpose on all counts by providing a single and unique platform for investigators to communicate with each other as well as various stake holders of the clinical trial.

It will provide easy and faster access to information like study and patient data and also access to medical and clinical literature. It will enable investigators to track the status of the trial online and also will improve compliance to drug safety by immediate reporting of the Serious Adverse Events (SAEs) and Adverse Events (AEs) through faster flow of information across sites and sponsor.

The Investigator Portal has to meet the current needs of clinical operations, the important features of which have been described below.

a. Single source of information: The investigators portal available from several pharma companies and third party vendors currently serve as a single and major source of clinical and medical information with the single log on. It provides information on drug and devices related to areas of clinical, biological, genetic and pharmaceuticals.

The generic areas covered are:

• Therapeutic targets
• Drugs and Biologics
• Metabolism
• Experimental Pharmacology
• Genomics
• Biomarkers
• Clinical studies
• AEs/ SAEs reporting
• Adverse Drug Reaction (ADR) reporting, and
• Literature.

Besides serving as a vast source of rich and scientific information, the web portal will also serve as a single source of information for clinical investigators to access the trial and patient related data from disparate clinical trial systems and databases being used by the sponsor. A unique user ID and password can enable the investigators to access the trial specific information they are involved with. Benefits of customised access to investigators helps in providing information related to the following:

• Investigators will have online updates on protocol amendments and help to maintain adherence to the clinical protocol and sustain compliance to the protocol throughout.
• Updates on the emerging regulatory and compliance requirements on patient safety , clinical data accuracy and integrity, trial conduct and drug safety to sustain end to end compliance
• Online access to laboratory data for the individual patients will help in tracking abnormal lab reports and ensure timely treatment incase of any clinically significant episodes.
• Online tracking of several episodes of AEs and SAEs from the laboratory and patient data will ensure patient safety at all times thus improve the health of clinical research studies.
• The online information about the sponsored research grants available will enable interested investigators to get in touch with the sponsor pharma company through the web portal.

b. Single interactive and collaborative platform:

(Left to right) AnkashaTejam and Suguna Nandgaonkar. The authors are consultants, Healthcare and Life Science Practice, Infosys Consulting. Address for correspondence: Suguna_Nandgaonkar@ infosys.com

Clinical research and pharmacovigilance can be made technologically advanced by using interactive channels of communications with multiple stakeholders involved in clinical research. Having a collaborative platform will have several business imperatives in the interest of the sponsor to effectively execute the study and also provide exhaustive online access to the investigators for seamless functioning of the trials. This will in turn ensure prompt responses to drug adversities, patient safety and compliance requirements which is prime focus of any clinical investigator.

In the past, investigators were involved in clinical research only from subject recruitment to trial closure; however off late pharma organisations involve them right at the stage of study design and protocol development. Normally a panel of clinical investigators is chosen for the study design wherein they participate in extensive discussions and meetings for finalising the clinical protocol. These activities depend heavily on email communications, group meetings and conferences. Facilitating the whole activity through live audio-video web conferences through an interactive portal will save significant time and cost, allowing different investigators located across different geographies to communicate and reach a common consensus much faster. The interactive portal will also enable investigators to communicate with other clinical teams for routine trial related activities. During the course of the trial, there might be a need to make amendments in the clinical protocol, depending on the early trial outcome. All such unforeseen trial delays can be well communicated, coordinated and implemented through effective use of the web portal.

c. Improved compliance for drug safety

The portal will enable faster flow of information not only unidirectional that is from sponsor to different sites but bidirectional that is from different trial sites to sponsor. SAE forms can be made available to investigators through the portal. As soon as any patient experiences an SAE, the SAE can be reported directly on the web portal by the investigator and can be sent to sponsor. Also different investigators working on the same trial can communicate in advance about SAE reports from individual sites. This keeps all investigators well informed about the SAEs expected, the frequency and the type of SAEs across sites and ensures appropriate preventive measures to be initiated in terms of change in the treatment, dosage frequency, or alternative support.

Currently SAEs reported across multiple centers are summarised and updated to the team of investigators as safety mailing information over two-three months time. Access to online SAE alerts will help investigators keep a track of similar incidents and take timely measures.

Immediate reporting of SAEs on the web portal will avoid delays of SAE reporting through fax and emails and also minimises the documentation discrepancies between SAE forms and Case Report Forms (CRFs) thereby reducing SAE reconciliation efforts at a later stage of the trial process.

Conclusion

There are several new IT enabled services being currently explored in the clinical research space to make operations seamless with a focus on high quality of data and regulatory compliance. Several Clinical Data Management Services (CDMS) and Clinical Trial Management Services (CTMS) based applications have flooded the market. However very few companies presently offer services of an Investigator Portal, which are currently customised portals either provided by the company or through the CRO/third party vendor.

The Investigator Portal, which in its current form is more of an information based portal, can evolve as single point of access 24x7 to research investigators and help in providing critical outcomes in clinical trials and in managing pharmacovigilance activities of sponsor companies. A clinician's exposure to an interactive portal can proactively bring in several benefits to the sponsor companies concurrently.

It can help in effective management of clinical trials with very little chance for delays and protocol slipovers and guarantee patient compliance and close follow up by the physicians. The incidence of patient drop out, AEs and SAEs can be managed effectively which contribute majorly to the success rate of any clinical trial outcomes.

The portal can also contribute towards spreading awareness of several chronic and infectious conditions and new drugs for treatment in line for clinical trials to investigators and thus contributing to social medicine by dispersing information to the connected medical fraternity and patient forums.

As we try and explore several promising and plausible benefits of Investigator Portals, it is vital to ensure individual investigator licensing, authentication of accreditations to specialty medicine and measures to ensure secure access to the online systems to avoid cyber crimes.

Several other areas where an investigator is involved with multiple stakeholders can be explored further and can be made more robust which might work more as an online clinical desk and research portal at the same time.